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RALEIGH, N.C. -- Startup TechWire ( has launched to champion entrepreneurs and innovation.


The professional news outlet reports on business, innovation, and education for America's vibrant startup community, especially the life sciences.


“The number of entrepreneurs across the U.S. is constantly growing, but not everybody is hearing about all the new tech that’s out there. It’s exciting to help build a stronger innovation community by sharing news and information on these startups and the businesses that support them,” David Menzies, editor/publisher, said.


Nearly a fifth of working adults in the U.S. – approximately 27 million people – identify as entrepreneurs. Many of these are solopreneurs, running a business alone without employees in order to stay lean and nimble to adapt to change, although this is somewhat limiting to scalability.


Many of these solopreneurs, Menzies explained, do not have the resources to get their stories out.


“That’s one of the ways Startup TechWire can help, by showcasing their products and ideas as well as covering trends related to their technologies,” he said.


Larger entrepreneurial trends in 2016 include innovation in utility apps geared toward “real life” issues such as travel, health and fitness, music, and news; bots and artificial intelligence; and products that promote productivity.


Menzies originally began publishing the tech news website as a means to generate extra visibility and web traffic for clients of his PR consultancy, Innovative Public Relations. Peers in the PR field began asking him if they could send their clients’ news items, and the publication grew, with Menzies utilizing his years of experience as a print newspaper editor to cull submissions and put forth a professional publication.


Word of mouth generated interest beyond the publication’s initial focus on North and South Carolina, with Startup TechWire now covering the entire U.S.


Fresh, original articles and user-submitted news items are updated daily, complimented by feeds from respected media sources.


Startup TechWire is an extraordinarily powerful and effective means of reaching a great number of people locally, nationally and globally.


For more information on editorial and advertising opportunities, visit or email This e-mail address is being protected from spambots. You need JavaScript enabled to view it .


About Startup TechWire

Startup TechWire ( reports on business, innovation, and education for America's vibrant startup community. It is a professionally edited online news outlet providing readers with timely information about the life sciences, entrepreneurism, high tech and education. Fresh, original articles and user-submitted news items are updated daily, complimented by feeds from respected media sources. Startup TechWire is published by Innovative Public Relations, Inc., a publicity and branding consultancy helping clients achieve their business development and organizational goals. All content is edited by Editor/Publisher David Menzies 919-274-6862 ( an award-winning 22-year professional communicator, published author and former print newspaper editor with a rich technology background.


Tagged in: bio innovation news
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By Jason Bissessur

Supple and smooth skin in our early youth can mirror the ‘ageless’ glow of clear vitality until after a while when ‘ageing’ nooks and crannies start to kick in.

Environmental culprits on the skin such as adverse weather and pollution can leave our sensitive coats looking dryer and duller by the day. But over time skin can reveal more grisly surprises on its surface, most commonly Thread Veins (aka ‘Spider’ veins for a more scare mongering term), a condition that affects 1 in 3 men and women.

Although the exact cause is not known with experts who speculate factors such as changing hormones and extreme weather conditions, there are readily available treatments that can lessen the impact of these ‘bulging’ dark veins.

This takes us swiftly onto the rejuvenating ‘holy grail’ science of IPL (Intense Pulsed Light) Thread Vein Removal, a procedure that beams intense rays of light directly onto the surface of these thread veins. Without damaging any surrounding tissue, the exposing heavy light causes blood inside the veins to dry and harden, making them absorbed naturally by the body and hence the result of a less visible appearance onto the skin.  Voila!

With such intense treatment, some might even wonder what does it feels like to have these dark spider-like veins vanquished. In fact, people that have undergone the procedure have experienced a warm prickly pin feeling or ‘tingly’ sensation when light is beamed onto their skin, but is pleasantly tolerable throughout.

For best results, it is recommended to have at least 4 treatments for every area affected by thread veins, leaving ideally 3 weeks in-between treatments to notice the effects. It’s a straightforward no brainer due to its remarkable simplicity, that can be done in 1 hour after work and back in time next day to the office!

As you know all treatments come with its own potential side effects, but these are rare but worth knowing anyways. Don’t fear! The chances you getting these is little as the likelihood of getting squished by the moon!

Side Effects may include:

-Burning where the area of thread veins is treated

-Blistering where the area of thread veins is treated

-Swelling where the area of thread veins is treated


However ‘scary’ these side effects may seem, it’s very rare and if you do get any of these reported symptoms, it will certainly heal over time!

Tagged in: aging anti-aging tip
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Posted by on in Health

Antioxidants aid in protecting skin cells against collagen-degrading enzymes so skin looks less wrinkled. They also counteract free radicals thus help reduce damage caused by strenuous exercise, harmful chemicals, and UV radiation.

Studies show that a blend of anti-oxidants are more effective than single anti-oxidants used alone.

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Enjoy your cup of coffee and feel free to browse through selection of the most interesting materials produced for various projects in the last couple of years.

Library router:

Course Global Pharma Primer: The material included in these five modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiveness of pharmaceutical products.  We introduce and describe the highly specialized and often disconnected components of pharmaceutical research, drug development and manufacturing, marketing, regulatory policies and practices, and use case studies to qualify the relative effectiveness of safeguards to prevent harm.  Additionally, how have pressures to reduce health care costs or increase safety actually affected both aspects of public concern within a global context because transnational interests influence national circumstances.

Survival guide to stem cell research and therapies: the course provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.

Big data in drug safety: The paper makes a case for change in the way data on safety of medicines is collected, structured, analyzed, visualized, and shared; moving away from the system of active reporting of individual case reports into national and international databases, toward collection and analysis of anonymous structured summary data from health care providers, in order to allow analysis of total numbers of treated patients and treatment outcomes; including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients’ privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.

Risk analysis primer: A variety of representative drug cases that have led to regulatory revisions will be template across the develop model to illustrate where signal detection could have been noticed that would have reduced patient casualty by providing an improvement in understanding to physicians prescribing medicines as an entry point for multidiscipline inclusion in process optimization and hazard reduction. Can drug development timelines be compressed while increasing regulatory confidence that public health interests and protections also advance?

Risk management plan (RMP) for opioid therapy: Prescription opioids cause more deaths than all illicit drugs combined. Law enforcement focus is on strict control of Rx and preventing diversion. This RMP focuses on frequent control of therapeutic range (TR). Frequent TR checking is possible if there is high capacity equipment with high sensitivity and specificity. Minimization of sample preparation time reduces labor time and overall cost.

Book Medicines for Women by Mira Woolrych-Harrison to which I contributed by co-authoring chapter “Political and religious perspectives on managing the risks and benefits of women’s medicines,” with review of the chapter by Frank Wallace, MD (Avatar Worldlink).

Paper “The human rights responsibilities of multinational pharmaceutical firms in host nation states” published in Journal of the International Relations and Affairs Group in June 2012 analyses the responsibilities of global pharmaceutical industry when conducting research in developing economies.

Article “The dangers of outsourcing personal medical data of PTSD patients” (Monitor SIRS, 2012) analyzes the risks associated with uncontrolled outsourcing of processing of medical data of PTSD patients.

Boyd cycle in clinical research and drug safety: To make any system oriented toward desired outcome, systems approach is necessary to make the feedback mechanism work. Boyd’s OODA loop is an elegantly simple grand theory, which contains high quality insight into strategic essentials. OODA loop has extensive domain of applicability, including clinical research and post-market drug surveillance.

Lessons from big industrial accidents and their relevance for the pharma industry, as presented at the 4th World Congress of Clinical Safety, Vienna (2015) organized by International Association of Risk Management in Medicine (IARMM).

Systems Theoretic Accident Model and Processes (STAMP) can be utilized in pharmaceutical industry in multiple different ways to define safe range of operation, impose constraints and enforce them by design and operations.

Course on Good distribution practice and supply chain security is currently under preparation. It will cover introduction into the regulatory environment in the U.S., EU, Japan, China, India and Russia, review case studies and enforcement actions in the area of product tampering and counterfeiting, and explain the impact of globalization and consolidation on supply chain security.

Resource guide relating to the 1080 scare in New Zealand: In November 2014 dairy giant Fonterra and national lobby group Federated Farmers received anonymous threatening to put 1080 poison in infant formula unless the government banned the agricultural pesticide by the end of March. In early March, the New Zealand police held a press conference, in which they appealed to the public for information regarding the threats. Environmental terrorism was widely discussed as the underlying motive. In October 2015, the case took a surprising turn, when local businessman was charged with criminal blackmail.

Current Good Tissue Practice (CGTP) governs the methods used in, and the facilities and controls used for, the manufacture of human cells and tissue based products (HCT/Ps) including all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution. (21 CFR 1271: CGTP).

Application of risk, issue and opportunity management in drug development: the presentation covers establishing an effective risk management process, risk management, relation to other risk management systems, issue management, opportunity management and management of cross-program risks.  Special attention is paid to alignment of risk management programs between stakeholders in clinical research, specifically the sponsor, investigator, and IRB/EC.

Book Dark Side of a Mountain is a historical study of the effects of ideology, religion and culture on medical science. Section The Code is dedicated to The Book of Leviticus and its 12th century annotation by Moses Maimonides. The root cause of the 1348 plague was flawed life-science doctrine which could not be challenged due to ideological and religious terror. Section Medical Oaths presents different concepts in medical ethics around the globe. Japanese medical ethics gets special attention, due to unique relationship between martial arts and the art of medicine. Eugenic Trail deals with the topic of pedigree, hereditary entitlement and inbreeding, and search for the causes of societal evils. Eugenics transformed from science to ideology in the mid-19th and early 20th century, but only in Nazi Germany it took on its most malignant form. Whilst the American version was driven by quest for hereditary causes of crime, harlotry, and pauperism, European cousins were pushing a case for the indispensability of noble families out of fear of spread of French troubles (the Revolution of 1848) to surrounding monarchies.

About 90% of all risk management efforts within the industry concentrate on regulatory compliance. Here is an overview of EU regulations in pharmacovigilance.

Diabetes drug Avandia (Rosiglitazone, GSK) was a promising medication and a top-seller until 2007, when its cardiovascular side effects and FDA’s role in evaluation of its safety came under intense public scrutiny. Avandia triggered discussion on FDA’s role in evaluation of safety of Avandia, and other medicines, and the need for reform in post-market surveillance. STAMP case study utilized research and materials produced during coursework on Life-Cycle Strategic Plan for the same drug.

Reliance of authorities on insider information requires adequate protections offered to whistleblowers, i.e. counseling, financial and legal aid, re-qualification, resettlement and/or a witness protection programs. Risk to whistleblowers is difficult to assess because of unavailability and inaccessibility of relevant data. Little information is available on the outcomes of whistleblower suits in federal/state courts. Obtaining data directly from state courts’ systems would require review all tort filings — a prohibitively expensive and time-consuming process.

Area study on Ukraine from June 2015 (resource guide):

Research: Czechoslovakian hospital in North Korea during the Korean War and Activities of Czechoslovakian scientists in the 1950s. Material for this research was collected in 2012 in the Military Historical Archive in Prague and includes wide range of documents mainly from the funds of Ministry of National Defense from the early 1950’s.

That's it for now, enjoy your coffee!

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In the last 7 years, in the period from January 2008 to March 2015, the FDA conducted more than 133,000 inspections. About half of this figure concerned foodborne biological hazards, Food composition, standards and labeling, and food and color additives. About 11,000 of all inspections, or 9%, related to drug quality assurances, and only a tiny fraction (362) identified unapproved and misbranded drugs.

Inspections are classified to reflect the compliance status of a firm. Classifications are based upon findings identified during an inspection and Agency review for compliance.

Bioresearch Monitoring 3 298
Blood and Blood Products 8 123
Colors and Cosmetics Technology 773
Compliance: Devices 11 822
Drug Quality Assurance 10 902
Food and Color Additives Petition review 3 619
Food Composition, Standards, Labeling 6 490
Foodborne biological hazards 50 370
Human, cellular, tissue and gene therapies 3 850
Interagency cooperative activities 1
Molecular biology and natural toxins 28
Monitoring of marketed animal drugs, feed and devices 12 293
Pesticides and chemical concominants 4 766
Postmarket assurance: devices 6 162
Postmarket surveillance and epidemiology 542
Pre-approval evaluation of animal drugs an food additives 190
Project evaluation: devices 2 225
Tobacco 103
Unapproved and misbranded drugs 362
Vaccines and allergenic products 402

Inspection classification database

Inspection classification database
Complete Inspection Classification Dataset


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Medicinal products are manufactured from active substances. The holder of a manufacturing authorization has to verify registration of the source of their active substances, and verify compliance of their suppliers with Good Manufacturing Practices by on site audits.

Title IV of Directive 2001/83/EC specifies the rules for manufacture and importation of medicinal products. The holder of a manufacturing authorization has to comply with Good Manufacturing Practices and must only use active substances, which have been manufactured in accordance with the principles of Good Manufacturing Practice and distributed in accordance with Good Distribution Practice.

It is the responsibility of the Member States GMP and GDP compliance of subjects on their territory, and enter the information provided by the distributors and manufacturers in the "EudraGMDP database", also called the “Union database”.

So what kind of secrets the database really holds?

The data reflect content of the EudraGMDP database. This dataset is necessarily incomplete, because at least eight European countries did not yet enter their data. Despite its limitations, EudraGMDP is still a valuable resource, which renders a lot of useful information.

According to the database, more than 6,500 authorizations were issued to wholesale distributors by national competent authorities within the EU.

Three countries account for more than half of all EU authorizations: the United Kingdom, the Czech Republic, and Poland. Full 70% of all authorizations were issued in 6 countries.

The number of issued authorizations does not correspond with total sales or population density. The number of authorizations does not correspond with the “Big Five” pharma markets – the United Kingdom, Germany, France, Italy and Spain. Italy did not enter their data at all, and authorizations issued by Spain represent only a tiny fraction.

Another useful metrics is the number of Good Distribution Practice certificates issued by each member state. Of almost 2,000 GDP certificates issued in 2014 in the EU, nearly 60% were granted by the MHRA. Full 80% come from four EU countries – the United Kingdom, Sweden, the Czech Republic, and Portugal.

Of the nearly 1,500 certificates issued in 2015, more than 50% were issued by the MHRA. Full three quarters new GDP certificates come from four countries – the United Kingdom, the Czech Republic, Portugal and Ireland.

The database also contains GDP non-compliance reports. To date, only three GDP non-compliance reports can be found on the database: two from the Czech Republic and one from Malta. The two Czech reports did not mention the nature of violations, except for non-compliance with the requirements of Good Distribution Practice. The report from Malta was more specific in detailing the nature of non-compliance and specified trade in falsified medicinal products not purchased from the legal supply chain, failure to conduct due diligence before purchasing from a new supplier, incorrect and incomplete information given to inspectors, and failure to effectively recall the concerned products.

Not a word about total number of inspections or their outcome. 28 FOIA requests would easily resolve that.

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I wish to comment on the concerned draft guidance and propose introduction of certain measures that would facilitate informed decision-making by stakeholders involved. All participants in the system need reliable and accurate information to make better treatment decisions: patients who consider stem cell treatments, healthcare professionals who care for these patients before and after such treatment, and payers, who may or may not wish to include these therapies in their programs depending on their benefits, risks, and cost-effectiveness.

The Helsinki Declaration says on unproven Interventions in Clinical Practice:

In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available. (Art 37)

Most stem cell interventions are not reimbursed by insurers. Most of the time, patients have to pay for these treatments themselves. Patients are making decisions based on information they can find in public domain. Currently, it is very difficult to accurately evaluate the benefit:risk profile of stem cell treatments. Because procedures under 21 CFR part 1271 (CGTP) do not qualify as studies, treatment outcomes of these interventions are never made available to the public.

Interventions offered by establishments under 21 CFR part 1271 (CGTP) rely on studies that have already been done and published, as well as their own empirical experience from own medical practice. Brief overview of registered studies and published studies illustrate the scope and extent of the information gap on stem cell treatments and their outcomes.

To facilitate informed decision-making by patients, healthcare professionals, and insurers, I am suggesting creation of a registry into which information on stem cell interventions conducted under 21 CFR part 1271 would be reported. To make such undertaking worthwhile, the anonymized dataset would have to include indication, type of treatment, and treatment outcome. Not only this would greatly benefit patients, who would be able to make truly informed choice for themselves; this registry could also benefit healthcare professionals who would be able to compare stem cell interventions to other existing therapies.

In total, 5,298 studies conducted with stem cells globally as of January 7, 2016 ( Most studies are conducted in highly regulated markets in the U.S. and in Europe. Other popular destinations include China, Iran, Israel and Middle America.

Stem cell studies by recruitment status as of January 7, 2016 (

Conditions treated

The register lists wide variety of conditions studied in a manner that is difficult to assess. Many conditions are listed under wide variety of terms, often overlapping, some low level, and others very general and high level. It is therefore difficult to judge whether a study intervention should be at all included in a specific evaluation without detailed scrutiny of the study objectives and design. This task is challenging even for an experienced biomedical researcher, and virtually impossible for a non-healthcare professional.

Stem cell studies by conditions treated, August 2015.

Availability of study results as of January 7, 2016 (

Funders of studies that involve stem cells as of January 7, 2016 (


Vast majority of stem cell studies are interventional. The database does not allow the researcher to filter out studies where stem cells were used as the intervention, compared to study of other – non-stem cell – interventions studied on patients who previously received stem cells or other type of studies that do not study the efficacy and safety of stem cell intervention themselves.

Type of studies that involve stem cells as of January 7, 2016 (

Studies by phase as of January 7, 2016 (

Majority of stem cell research is in early phases of development. This involves lot of ambiguity and uncertainty for those undergoing such treatments, as well as for their regular healthcare providers and payers.

Number of patients enrolled in studies that involve stem cells as of January 7, 2016 (


Publications, publication bias and multiple publication bias

It is very difficult to assess the true value of stem cell intervention for a particular diagnosis based on information available in public domain, i.e. information from registries ( and WHO ICTRP) and published scientific literature. Most studies do not disclose results to the public, or do so with long delays. Publication bias and multiple publication bias makes certain results difficult to appropriately evaluate.

Simple search for stem cells in PubMed returns about 245,000 results. Of these, about 139,000 describe experience in humans. About 4,200 of the identified published papers are published clinical trials. The following examples illustrate how poorly information in public domain represents research that has been done.

Example: Amyotrophic Lateral Sclerosis (ALS, Aran-Duchenne Muscular Atrophy, Gehrig's Disease, Lou Gehrig's Disease)

  • 36 studies (“stem cells” & Condition: “ALS”)
  • Of these 36 studies, 32 are interventional, 3 observational and 1 expanded access
  • None of the identified studies have any results posted in the registry
  • Enrollment: Interventional ALS studies – 805 patients in total; expanded access – 0; observational studies – 1185 (1000, 160 and 25).
  • Of these 36 studies, 10 were ever published in scientific literature, some multiple times.
  • The same studies can be found in PubMed.

Publication of studies involving “stem cells” and condition “Amyotrophic Lateral Sclerosis”

Example: Sickle Cell Anemia (Thalassemia)

  • 46 studies (“stem cells” & Condition: “sickle cell anemia”)
  • Of these 46 studies, 39 are interventional and 7 observational
  • Three (3) of the identified studies have results posted in the registry
  • Enrollment: Interventional studies – 1066 patients; observational studies – 376 + 1 unlimited
  • Of these 46 studies, 7 were ever published in scientific literature, some up to 3 times:
  • PubMed search returns 22 human clinical trials for this particular diagnosis and stem cells. In total, 369 hits for “stem cells” AND “sickle cell anemia” mainly show results from animal and in vitro studies.

Publication of studies involving “stem cells” and condition “Sickle Cell Anemia”

Stem cell therapies potentially offer great benefits to patients whose current options are either limited or non-existent. Some patients are willing to undergo new, experimental and unproven therapies, to take advantage of this cutting-edge research. These people are taking all the risks associated with novel therapies and procedures upon themselves.

To protect the interests of patients, and to support innovation in this rapidly developing field of medicine, it would be wise to facilitate substantial improvement of the information environment, and to provide all parties involved with the information they need to make better treatment decisions.

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A while ago I was invited to comment on training procedures pertaining to triage of patients with mental health issues at a major UK hospital. This particular case study involves a nursing assistant who in his or her limited capacity has to decide how to handle each specific case many times a night.

The hospital asked its staff a simple question:

"In your capacity do you feel you have enough training and coping mechanisms in place to safeguard yourself and a patient experiencing mental- ill health?"

After considerable time spent interviewing staff over their knowledge and understanding of existing laws, regulations and procedures, the simple and short answer is “No”.

This particular A&E admits about 320-400 new patients a day, of whom about 20 are patients with some kind of mental health problem. This figure does not include patients with dementia. Some of these patients are violent as a result of alcohol or drug abuse. The hospital also has to handle patients with long-term previously diagnosed psychiatric conditions, new onset psychiatric conditions, including drug-induced psychoses, erratic behavior and seizures resulting from trauma, poisoning, adverse drug reactions or metabolic conditions or other underlying disease, and distressed victims of crime such as domestic violence or sexual abuse, and victims of human trafficking.

Clear and understandable instructions for staff are necessary to comply with all applicable laws, regulations, instructions, and with hospital policy.

The following intriguing questions for handling these cases shall be promptly resolved by management of the hospital, and appropriate procedures including training shall be circulated to people on wards to minimize any liability caused by improvisation and human error.

  • What is the standard procedure for obtaining informed consent from patients who are conscious and able (but unwilling) to give consent with admission for examination and treatment?
  • What is the standard procedure for obtaining informed consent in situations when the patient is unconscious, incapacitated, disoriented but conscious, incapable of giving consent and non-aggressive, aggressive and uncooperative?
  • What are the symptoms a nursing assistant need to watch out for before he/she shall escalate the matter and ask someone to decide?
  • What are the roles and responsibilities for making decisions on such cases?
  • Who is the correct person to go to if the initial assessment indicates that the patient is a mental health case?
  • When a nursing assistant is allowed to use force, and what are the appropriate techniques? Do they need to record in patient chart that force had to be used, and what technique was applied? What if the patient becomes injured during the procedure?
  • How does a nursing assistant know who is the patient’s next of kin? How does the hospital determine who is the most appropriate person to talk about the patient’s health, especially if his/her family status is less than straightforward? The hospital already experienced cases of family feud and honor killing. The city is also a major human trafficking hub.
  • How does staff communicate with other persons who came in with the patient (police, neighbors, family members, coworkers)?
  • Who is responsible for accepting restraining orders, warrants, and similar measures, and how does a nursing assistant find out? Is this listed in the patient documentation, or is this communicated during a handover brief? Does the note on file refer to applicable internal procedure?
  • Does the hospital separate appropriately guarded ward for patients who can endanger themselves, other patients and staff?
  • How does the hospital ensure that distressed victims of crime, especially domestic violence and rape, are not held together with potentially dangerous individuals in the same “mental health” ward?
  • What is the protocol for the treatment of victims of rape to make sure forensic evidence is not destroyed in the process?
  • If drug abuse is suspected, especially substances such as bath salts, what is the correct procedure for obtaining and handling samples? Does the hospital use LC/GC detection equipment where the samples can be examined quickly?
  • What if poisoning or drug-induced psychosis is suspected, including adverse drug reactions to Rx drugs and Rx drug interactions?
  • Who is responsible for triage of these patients?

This list is by no means exhaustive. It is, however, illustrative of some of the challenges first line staff faces on busy nights.

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NHLBI has issued the first in a series of Requests for Information (RFIs) to solicit input from its stakeholders on ways to optimize the clinical trials enterprise:

"Characteristics of a successful clinical trial (recognizing that a clinical trial can be assessed in a variety of ways, including but not limited to advancing science and completing a trial on time and on budget)"

Risks to project success often result from a sequence of logically dependent decisions and actions by independent entities that operate within a clinical trial. Any incorrect assumptions made earlier in the process of drug discovery and pre-clinical development about drug characteristics and mode of action, which cannot be independently verified or remain concealed or unrealized through subsequent development phases can contribute to a patient casualty.[1]

Information on products is heavily dependent on clinical studies generated by the industry or funded by the industry. Non-registered studies, unpublished studies, and delays in registration of studies create an important disconnect between produced results and perceived findings. Registration of clinical studies improved the situation considerably over the last 15 years but did not resolve the selective information flow from the industry to medical professionals (publication bias and multiple publication bias). Multiple publication of a positive study amplifies such information, creating a false positive incentive for prescription (widely publicized anecdotal finding) whilst suppression of negative studies (publication bias) limits access to potentially crucial information for healthcare professionals.[2]

Very varied design of clinical studies makes them difficult to interpret by the target audience (regulators and healthcare professionals). Industry can opt for wide variety of designs to prove value of the product. Uncertainty about risks plays in favor of the producer especially after the drug has reached the market. Intentional avoidance of the producer to design and conduct studies empowered to define risks to patients, and disclose and mitigate these risks accordingly, can be interpreted as intentional interaction with uncertainty.[3]

Redefinition of trial success vs. failure would profoundly affect the value of trial results to other stakeholders, i.e. clinicians, investors, payers, and patients.

Independent assessment of “value” of a clinical trial would enable researches, medical professionals, investors and payers to make valid and reliable assessments of large numbers of differently designed trials. Rigorous assessment of “value” of a trial would also provide incentive to trial sponsors to prioritize resources toward trials, which provide clinically meaningful information, and improve their overall metrics. Trials without posted results have no meaning and no value for the consumer.

  • Are questions posed by the trial clinically relevant? The use of surrogate endpoints in trials should always be compared against real life data (EHR) and true clinical outcomes.
  • Does the trial answer the questions posed with high internal validity[4] and construct validity[5]?
  • Does the trial have statistical power[6] to answer research questions posed with high validity and confidence? Unsuccessful clinical trial does not have the statistical power to answer conclusively research questions.
  • High confidence in cause and effect relationship is essential for truthful communication with investors and validity of any assumptions made in the future based on the results of such trial.
  • Uncertainty of the meaning of data coming from clinical trials, its validity, accuracy, and confidence, which can be placed on each study, may be resolved through standardization of design of certain types of clinical studies through implementation of ISO standards. ISO standardization could reduce many uncertainties and increase probability of detection of reasonably foreseeable risks for individual therapeutic areas.
  • Incentives toward timely and complete publication of trial results (
  • Incentives to include NCT number in all publications as a clear identifier of data source.
  • Discouragement of multiple publication of the same trial in multiple different journals.


[1] Valdova V, Sheckler R, Abdulkhaleq A, Wagner S: The usability of Systems-Theoretic Accident Model and Processing (STAMP) in drug development (manuscript, 2015).

[2] Valdova V, Sheckler R: Risk Analysis Primer.!risk-analysis-primer/c1h0v (Dec 2014)

[3] Ibid.

[4] Internal validity is the confidence that we can place in the cause and effect relationship in a study: “Could there be an alternative cause, or causes, that explain my observations and results?”

[5] Construct validity determines whether the program measured the intended attribute.

[6] The power of a statistical test is the probability that the test will reject the null hypothesis when the null hypothesis is false i.e. it will not make a Type II error, or a false negative decision. As the power increases, the chances of making a Type II error decrease. The probability of a Type II error is referred to as the false negative (β). Therefore power is equal to 1‐β, which is also known as the sensitivity.

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Learn the thorough medical definition of lochia at What is Lochia? - Adidarwinian


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The Medical Academy of Pediatric Special Needs (MAPS) is going to organize the MAPS Spring Conference 2015, from March 12-14, 2015, in Hilton Orange County, Costa Mesa. The 3-day conference will provide Clinician CME Training in fields of special needs children and Autism Spectrum Disorders (ASD). The conference aims to educate medical professionals about scientific medical conditions in kids with ASD.

The conference invites:

  • Medical Doctors (MD)

  • Doctor of Chiropractic (DC)

  • Doctor of Osteopathic Medicine (DO)

  • Naturopathic Doctor (ND)

  • Physicians Assistant (PA)

  • Registered Nurse (RN)

  • Nurse Practitioner (NP)

  • Certified Clinical Nutritionist (CCN)

  • Registered Pharmacist (Rph)

  • Pharmacist (PharmD)

  • Psychologists with Doctorate (PsyD)

  • And other nutrition and healthcare providers




Leading scientists and medical practitioners are going to share their knowledge in the conference as speakers. The knowledge offered by these experts will reach beyond typical lecture series. They will put forth working case studies, and evidence supporting the treatment of certain conditions.


The honorable speakers of the MAPS Spring Conference 2015 are:

  • Dr. Sidney Baker

  • David Berger, MD (MAPS Faculty)

  • Jeff Bradstreet, M.D., M.D.(H), FAAFP, FMAPS

  • Dr. David Dornfeld

  • Stuart Freedenfeld, MD

  • Dr. Richard Frye

  • Dr. Suzanne Goh

  • Jerry Kartzinel, MD

  • Vicki Kobliner

  • Arthur Krigsman, MD

  • Elizabeth Mumper, MD, FAAFP

  • Dr. Nancy O’Hara

  • Dr. Dan Rossignol (MAPS President)

  • Dr. Cindy Schneider

  • Dr. Anju Usman

  • Dr. Vincent, MD

  • Dr. Robert K. Naviaux, MD, PhD


Topics of Lecture:


A few topics on which the speakers will share their valuable knowledge, are:

  • Advanced nutritional assessment

  • GI abnormalities and inflammation

  • GI testing and clinical pearls

  • Normal metabolism / methylation and sulphation abnormalities

  • Mitochondrial dysfunction and oxidative stress

  • Endocrine abnormalities

  • Reversible causes of autism

  • LDI as a treatment option for lyme

  • Update on new research findings


The Maps Spring Conference 2015 will see the speakers offering insight into innovative, new and different ways to treat different medical conditions. Attending the conference will prove to be highly beneficial for health practitioners, especially those in the field of ASD treatment.

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Sartorius has attributed double-digit growth figures in 2014 to increased demand across the US for single use technologies.

The firm posted a 32% growth in sales across the region. For the full year, the international laboratory and process technology company reported sales across its business of 891 million Euros ($1.01bm).

This is up 13% on 2013. Sartorius’ bioprocess solutions division, which provides technologies and services to the biomanufacturing industry, generated 70% of the total revenues.

Group CEO, Joachim Kreuzburg, said “overall” 2014 had proved to be a “highly successful year” for the firm. “Our largest divisions, Bioprocess Solutions,” he added, “reported double-digit gains for the fourth year in succession and again proved to be the key growth driver for our company’s sales and earnings.

“The results for Lab Products & Services were still impacted by portfolio cleaning, as expected, but with the start of the new year, this is now behind us.”

Bioprocess solutions stimulating the growth

Inga Stucke, a spokesperson for Sartorius, said the growth had been led by its bioprocess solutions unit.

“Demand for single use products was high across our entire product range,” Ms Stucke said in comments to “It came from our fluid management products such as single use bags, filters and also from single use fermenters.”

For 2015, Ms Stucke predicted additional growth in its bioprocess division in the range of 5-8%.

In related news, Sartorius has just completed the sale of its Industrial Technologies Division to the Japanese Minebea Co Ltd. The move is designed to free up more time and resources for Sartorius to direct towards bioprocessing and laboratory equipment.

Related reading:

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0 Lumiprobe fluorescent reagents

Inside this newsletter
  • Useful for Manufacturing Oligonucleotide Therapeutics
  • Citations of Interest
  • Scientist's Questions - Increase your knowledge and ideas!
  • Lumiprobe New Years greeting!

Lumiprobe reagents reduce cost, increase productivity and improve quality of research and production. Thanks to all ! Save 5% use discount code: biocrowd

Lumiprobe offers over 80 reagents for peptide, oligonucleotide, amine, alkyne binding - useful for Manufacturing Oligonucleotide Therapeutics!

In 2014, whether researching, creating, or manufacturing new drugs and treatment, Lumiprobe reagents were giving results in drug development research. Click chemistry was used with peptide-based nanoparticles in vivo, comparing the advantages between linear and cyclic peptides for intracellular delivery, process improvements for the economic  production,  peptide characterization , detecting and controlling oligonucleotide impurities, and exploring the development of peptides for diagnostic applications.  Novel oligonucleotide and peptide therapies were also enhanced when Lumiprobe's reagents were included.

Dye NHS esters - amine-reactive cyanine activated esters for the labeling of proteins, peptides, and other molecules

Sulfo NHS esters - water soluble sulfo-Cyanine3 SE activated ester for amino-biomolecule labeling.

Azides - fluorescent biomolecule labeling through Click Chemistry

Alkynes -
alkyne dye,  Useful for both copper-catalyzed, and copper-free Click Chemistry.

Maleimides -
bright and photostable thiol-reactive dye for protein labeling

Amines - fluorophores with free amino group (amino-dye). It can be conjugated with NHS esters, alkynes, carboxy groups (after activation), and epoxides.

Hydrazides -
dyes with a reactivity for carbonyl groups (aldehydes and ketones) activated by acid.  It can be used for the labeling of glycoproteins (i.e. antibodies) after periodate oxidation of sugar moieties.

Citations of Interest !

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Over 100 papers sorted by date or reagent are available for your review.
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In Site-Selective Protein Immobilization by Covalent Modification of GST Fusion Proteins.
Zhou, Y.; Guo, T.; Tang, G.; Wu, H.; Wong, N.-K.; Pan, Z.
Bioconjugate Chemistry, 2014 doi: 10.1021/ bc50 0347b

The immobilization of functional proteins onto solid supports using affinity tags is an attractive approach in recent development of protein microarray technologies. Among the commonly used fusion protein tags, glutathione S-transferase (GST) proteins have been indispensable tools for protein–protein interaction studies and have extensive applications in recombinant protein purification and reversible protein immobilization. Here, by utilizing pyrimidine-based small-molecule probes with a sulfonyl fluoride reactive group, we report a novel and general approach for site-selective immobilization of Schistosoma japonicum GST (sjGST) fusion proteins through irreversible and specific covalent modification of the tyrosine-111 residue of the sjGST tag. As demonstrated by sjGST-tagged eGFP and sjGST-tagged kinase activity assays, this immobilization approach offers the advantages of high immobilization efficiency and excellent retention of protein structure and activity.

EGF receptor-targeting peptide conjugate incorporating a near-IR fluorescent dye and a novel 1,4,7-triazacyclononane-based 64Cu(II) chelator assembled via click chemistry.
Viehweger, K.; Barbaro, L.; Garcia, KP; Joshi, T.; Geipel, G.; Steinbach, J.; Stephan, H.; Spiccia, L.; Graham, B. Bioconjugate Chem., 2014, 25(5), 1011–1022. doi: 10.1021/ bc50 01388

A new Boc-protected 1,4,7-triazacyclononane (TACN)-based pro-chelator compound featuring a “clickable” azidomethylpyridine pendant has been developed as a building block for the construction of multimodal imaging agents. Conjugation to a model alkyne (propargyl alcohol), followed by deprotection, generates a pentadentate ligand, as confirmed by X-ray crystallographic analysis of the corresponding distorted square-pyramidal Cu(II) complex. The ligand exhibits rapid 64Cu(II)-binding kinetics (>95% radiochemical yield in <5 min) and a high resistance to demetalation. It may thus prove suitable for use in 64Cu(II)-based in vivo positron emission tomography (PET). The new chelating building block has been applied to the construction of a bimodal (PET/fluorescence) peptide-based imaging probe targeting the epidermal growth factor (EGF) receptor, which is highly overexpressed on the surface of several types of cancer cells. The probe consists of a hexapeptide sequence, Leu-Ala-Arg-Leu-Leu-Thr (designated “D4”), followed by a Cys-β-Ala-β-Ala spacer, then a β-homopropargylglycine residue with the TACN-based chelator “clicked” to its side chain. A sulfonated near-infrared (NIR) fluorescent cyanine dye (sulfo-Cy5) was introduced at the N-terminus to study the EGF receptor-binding ability of the probe by laser-fluorescence spectroscopy. Binding was also confirmed by coimmunoprecipitation methods, and an apparent dissociation constant (Kd) of ca. 10 nM was determined from radioactivity-based measurements of probe binding to two EGF receptor-expressing cell lines (FaDu and A431). The probe is shown to be a biased or partial allosteric agonist of the EGF receptor, inducing phosphorylation of Thr669 and Tyr992, but not the Tyr845, Tyr998, Tyr1045, Tyr1068, or Tyr1148 residues of the receptor, in the absence of the orthosteric EGF ligand. Additionally, the probe was found to suppress the EGF-stimulated autophosphorylation of these latter residues, indicating that it is also a noncompetitive antagonist.

Size- matched alkyne-conjugated cyanine fluorophores to identify differences in protein glycosylation.
Burnham- Marusich, A.R.; Plechaty, A.M.; Berninsone, P.M.
ELECTROPHORESIS, 2014, 35, 2621–2625. doi: 10.1002/elps.201400241

Currently, there are few methods to detect differences in posttranslational modifications (PTMs) in a specific manner from complex mixtures. Thus, we developed an approach that combines the sensitivity and specificity of click chemistry with the resolution capabilities of 2D-DIGE. In “Click-DIGE”, posttranslationally modified proteins are metabolically labeled with azido-substrate analogs, then size- and charge-matched alkyne-Cy3 or alkyne-Cy5 dyes are covalently attached to the azide of the PTM by click chemistry. The fluorescently-tagged protein samples are then multiplexed for 2DE analysis. Whereas standard DIGE labels all proteins, Click-DIGE focuses the analysis of protein differences to a targeted subset of posttranslationally modified proteins within a complex sample (i.e. specific labeling and analysis of azido glycoproteins within a cell lysate). Our data indicate that (i) Click-DIGE specifically labels azido proteins, (ii) the resulting Cy-protein conjugates are spectrally distinct, and (iii) the conjugates are size- and charge-matched at the level of 2DE. We demonstrate the utility of this approach by detecting multiple differentially expressed glycoproteins between a mutant cell line defective in UDP-galactose transport and the parental cell line. We anticipate that the diversity of azido substrates already available will enable Click-DIGE to be compatible with analysis of a wide range of PTMs.


Tech Support: Lumiprobe offers FREE tech support before or after you order.
Questions - Increase your knowledge and ideas!

I have few questions about the click-chemistry labeling and need suggestions. In the protocol for Click-Chemistry Labeling of Oligonucleotides and DNA,
1.  Triethylammonium acetate buffer (final concentration 0.2 M, pH 7.0) was used. Does it matter that types of salts and pH of buffer effect the labeling efficiency? Can PB buffer be used?
2.  Azide was dissolved in DMSO and 1.5 * (DNA concentration), is it OK that azide was dissolved in water? In my experiment, azide was connected to peptide and had a good water solubility. Is it 50% DMSO necessary for the performance of click-chemistry labeling?
3.  Degass steps were performed during the procedure. Does it sensitive to oxygen?
4.  Precipitating the conjugate with acetone or ethanol was preformed to remove excess small molecules. Can Amicon ultra 3K device (Millipore) for buffer changing get the same result?
5.  Can reaction yield get >90%? Will +4 Centigrade lower the yield?

Thank you for your email!

1. In practice, Click Chemisty displays little dependence on the composition of buffer. It should not contain free thiols (i.e. no DTT or mercaptoethanol). The reaction can be carried out at pH of at least 4 to 10. I believe phosphate will work fine.
2. You can dissolve your azide in water without any issues. The protocol uses DMSO because it is optimized for non water-soluble azides.
3. Yes, the reaction is sensitive to oxygen. Alkyne dimers can form upon oxidation. Moreover, hydroxyl radicals are formed upon oxidation of Cu(I) catalyst, and they can damage biomolecules, especially DNA/RNA. We recommend to degass the solution.
4. Any purification will work, precipitation is the easiest for oligo labeling. You can desalt the reaction.
5. Yes, yields may exceed 90%. Lowering temperature to +4 Centigrade will not harm, but probably will extend the required conjugation time.

Please do not hesitate to contact Lumiprobe if you have more questions.

Actually, I do have one more question about NHS-ester labeling. The optimal pH value for modification is 8.3-8.5. In most cases I saw, the pH value suggested is 7.4. For example, SDA (pierce, product 26167) I used for proteins labeling is used in PBS. Is there any difference between DNA labeling and protein labeling? The pKa value of primary amines is the key factor?

Optimal pH for NHS ester labeling is indeed 8.3-8.5. pH value of 7.4 can be used if you need to label preferably N-terminus of a protein rather than side chains of lysine. The terminal amino-group is less basic than lysine amine, and it is less protonated at this pH than that of lysine. Therefore, it reacts preferably with the NHS ester. At higher pH ranges, both amino groups are non-protonated, and since lysine amines are more reactive, they react first.

If you need to label protein lysines or aminolink-DNA, use pH 8.3-8.5.

Do you provide the service which conjugate peptide to cy5 NHS ester?

Unfortunately, Lumiprobe does not make labeled peptides and does not perform conjugation. However, Lumiprobe can supply you or service company of your choice with our fluorescent reagents. The labeling protocol is simple enough to be performed by you. If you have peptide purification facilities such as HPLC -  if you work with peptides, you likely have it). If you prefer labeling as a service, there are local companies who do it - Lumiprobe can supply our reagent to this company. This will help save money on reagents.

Why use Lumiprobe's fluorescent dyes such as Cyanine5 NHS ester?

Cyanine5 fluorophore emission has maximum in red region, where many CCD detectors have maximum sensitivity, and biological objects have low background. Dye color is very intense, therefore quantity as small as 1 nanomol can be detected in gel electrophoresis by naked eye.

* high quality,  ideal for very cost-efficient labeling
* works well in organic solvents for small molecule labeling of soluble proteins,
peptides and oligonucleotides
* Water-soluble sulfo-Cyanine 5 NHS ester for sophisticated cellular & protein targets
* Compatible with various instrumentation including fluorescent microscopes,
imagers, scanners, and fluorescence readers.


Send your tech questions ? Any comments on the newsletter? What information would you like in the next issue?

Lumiprobe New Year's greeting!
Restock your lab in January and save 5%.
Use discount code: biocrowd

Thank you for integrating Lumiprobe fluorescent probes into your work in 2014!
Restock your lab or begin a new project - Lumiprobe offers you a new year's email discount of 5%. Use discount code: biocrowd

If you need something not found in Lumiprobe's catalog - ask!

Lumiprobe offers to help with your research, and create a custom probe for you at no extra charge! Reagents can often be customized for your needs at price schedule similar to Lumiprobe's other reagents. Ask Lumiprobe's tech support - you'll receive attention to your research, and ideas on what or how to do the click chemistry reaction. Lumiprobe's website offers instantly downloadable Certificate of Analysis (CoA) detailing meticulous quality control, real NMR, UV and mass spectra, and HPLC chromatograms.

Lumiprobe |    Products/Technical Info |    Protocols |    Ordering |    Contact

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Posted by on in Uncategorized

Single-use technologies have revolutionised the biopharmaceutical industries in more ways than you might think. It is indeed most common nowadays to see single use applications cascading along the many upstream and downstream processes which channel through the sector.

But what about the people who work tirelessly along the bioprocess supply chain? Well, it would seem Starbucks Japan has woken up and smelt the coffee when it comes to single use. The company’s outlets across East Asia are keeping  biopharmaceutical workers - along with the public - topped up on coffee which is brewed with a twist.

The art of great coffee

Starbucks Origami Personal Drip coffee is the first Starbucks single use drip coffee product offered in the world. Pick from one of three roasts, open the sealed bag, fan out the origami filter, affix to a mug and pour hot water over the ground beans.

Then sit back and enjoy the perfect blend.

Personal Drip, so says Starbucks, invokes the “artistry and hand-crafted nature of Japan’s ancient art of origami and this innovative product allows customers to brew a single cup of Starbucks coffee at home that does not require any special equipment”.

We’d have to agree. After all, at ALLpaQ we like to think of ourselves as coffee connoisseurs. Even so, this is by far the most creative way we’ve seen of brewing coffee.

Right then, time to put the kettle on. Anybody want one?


Related reading:

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Bioprocessing news: The global single use bioreactors market looks set to expand at a two-fold compound annual growth rate over the next five years, according to a report by Research and Markets.

Back in 2014, the single use bioreactor market generated $202.5 million. This, says the report, could grow 18.4% to reach $470.9 million by 2019.

A single use bioreactor – or disposable bioreactor – is a bioreactor which harnesses disposable bags rather than a culture vessel.

The market expansion of single use bioreactors is being driven by a number of factors including the increasing deployment of the technology in developing markets such as China and India.

Commercial single use bioreactors

Research and Markets’ report segments the global single use bioreactors by molecule type, type of cell, technology, end user and region.

On their website, they explain: “The monoclonal antibodies (MAbs) segment accounted for the lion’s share of the global SUB market, by molecule type. However, the stem cell segment is expected to grow at the highest CAGR in the forecast period, owing to an increased focus on research in this segment.

“On the basis of type of cell, the SUB market is categorized into mammalian cell, bacterial cell, yeast cell and others (insect cell and plant cell). The mammalian cell segment is expected to be the new revenue pocket in the market by type of cell. Increasing numbers of biologics are being based on mammalian cells due to their increased compatibility and bioactivity in humans.”

“The technology segment,” continues Research and Markets, “is subsegmented into wave-induced motion SUBs, stirred SUBs, single-use bubble column bioreactors and others (single-use reactors with vertically perforated discs and single-use hybrid reactors). Wave-induced motion SUB technology is the oldest and most widely accepted of these, which accounts for its large market share.

“Research and development (R&D) of biopharmaceutical manufacturers, research institutes and contract research organizations (CROs) are the major end users of the SUB, followed by biopharmaceutical manufacturing. The large share of the R&D segment can be attributed to the wide acceptance of SUBs for small – and mid-scale biopharmaceutical manufacturing for clinical testing and R&D. New and innovative product launches were found to be the dominant strategy adopted by key industry participants to increase their market share and cater to unmet market needs.”

Single use bioreactors: key report topics

Key topics areas covered in Research and Markets’ single use bioreactor report, include:

  1. 1. Introduction
  2. 2. Research Methodology
  3. 3. Executive Summary
  4. 4. Premium Insights
  5. 5. Market Overview
  6. 6. Industry Insights
  7. 7. Single Use Bioreactor Market, By Technology
  8. 8. Single Use Bioreactor Market, By Molecule Type
  9. 9. Single Use Bioreactor Market, By Type Of Cell
  10. 10. Single Use Bioreactor Market, By End User
  11. 11. Single Use Bioreactor Market, By Geography
  12. 12. Competitive Landscape
  13. 13. Company Profiles

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Posted by on in Health

US bioprocess equipment maker, ABEC, has taken a step into the European market by purchasing a former electronic component plant in Cork, Ireland.

The facility, previously owned by French firm FCI, will become a producer of custom engineered bioprocess equipment for the clinical and commercial manufacturing of biopharmaceuticals.

Emily Smith, marketing coordinator at ABEC, said: “Similar to our US HQ, we will be able to engineer, design, manufacture, and test the entire bioprocess – upstream, downstream and ... keep reading ...

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Proprietors of single-use technology could be perfectly placed to play a leading role in the design and construction of biopharma facilities according to Kurt Gilson, western regional manager at Total Facility Solutions.

His comments come on the back of concerns expressed by a number of leading pharmaceutical companies about the increasing reliance on system vendors in the supply chain.

Mr Gilson, speaking to, downplayed such fears, underscoring greater flexibility and reduced costs as potential upsides if vendors were to play a more central role in the design of bioprocessing facilities.

“The use of disposable or single-use technology is dramatically changing plant design and construction,” he said.

“If the bioprocess manufacturing requirements align with the technology capabilities of the systems vendor, then the detailed design and construction of the plant by a systems vendor does not limit the plant flexibility any more than traditional delivery methods and could offer schedule and cost advantages.”

Back in October 2014, Sartorius Stedim Biotech received an award from the International Society for Pharmaceutical Engineering for the design of WuXi AppTec bulk cell culture production facility in China.

Even so, Mr Gilson said that in the current climate “few” equipment manufacturers had the “breadth of process technology to deliver complete systems including support utilities and cleanrooms”.

Total Facility Solutions is a subsidiary of engineering firm M+W.

Related reading:

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