Tuesday 31 May 2016

FDA issues recommendations to reduce the risk of Zika virus transmission

The U.S. Food and Drug Administration  (FDA) has issued recommendations to reduce the risk of Zika virus transmission by human cell and tissue products. There is a potential risk that the Zika virus can be transmitted by HCT/Ps used as part of a medical, surgical, or reproductive procedure.

The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational tissues. The new guidance is a part of the FDA’s on-going efforts to protect HCT/Ps and blood products from Zika virus transmission.

Commenting further, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, stated: “Though there is more to be learned about the transmission of Zika virus, given what we know about the virus at this point, which also is informed by our understanding of similar viruses, we must address the potential risk of Zika virus transmission by human cells and tissues. Providing HCT/P establishments with donor eligibility recommendations will help reduce that potential risk.”

The report can be accessed here.

Posted by Dr. Tim Sandle

Monday 30 May 2016

DNA 'tape recorder' to trace cell history

Researchers have invented a DNA "tape recorder" that can trace the family history of every cell in an organism.
The technique is being hailed as a breakthrough in understanding how the trillions of complex cells in a body are descended from a single egg.
"It has the potential to provide profound insights into how normal, diseased or damaged tissues are constructed and maintained," one UK biologist told the BBC.
The human body has around 40 trillion cells, each with a highly specialised function. Yet each can trace its history back to the same starting point - a fertilised egg.
Developmental biology is the business of unravelling how the genetic code unfolds at each cycle of cell division, how the body plan develops, and how tissues become specialised. But much of what it has revealed has depended on inference rather than a complete cell-by-cell history.

For more details on this, see BBC Science.

Posted by Dr. Tim Sandle

Sunday 29 May 2016

Bacterial Exposure Can Promote Type 2 Diabetes

A recent study has demonstrated a link between bacterial exposure and the development of diabetes mellitus type 2 (DMII). This important work could lead to new treatments or even prevention through species-specific interventions.

Staphylococcus aureus is an opportunistic bacteria that lives on the skin. Colonization by S. aureus is associated with expression of a superantigen called toxic shock syndrome toxin-1 (TSST-1) which results in systemic immune activation. Importantly, there is a positive correlation between obesity and S. aureus colonization. In a recent study using a rabbit model, scientists from the University of Iowa showed that S. aureus colonization, and the resulting TSST-1 exposure, results in a loss in glucose response, increased insulin production, systemic inflammation, liver damage and increased circulating endotoxin - all hallmarks of DMII. To validate these findings they measured TSST-1 levels in DMII patients and found elevated levels. This is the first direct connection between bacterial exposure and diabetes.

For further details see: PubMed

Posted by Dr. Tim Sandle

Saturday 28 May 2016

CBER - Blood and Blood Components

Listed below are the guidances that FDA CBER are planning to issue during the course of the year:

Relabeling of Apheresis Plasma Intended for Transfusion to Concurrent Plasma for Further Manufacture; Draft Guidance for Industry

Recommendations to Reduce the Risk of Transfusion-transmitted Chikungunya Virus (CHIKV); Draft Guidance for Industry

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry (Revised Draft1)

Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Final Guidance for Industry

Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry

For more details see: CBER

 Posted by Dr. Tim Sandle

Friday 27 May 2016

Failure Mode Effects Analysis for Filter Integrity Testing

From a more global point of view, the goal of failure mode effects analysis (FMEA) for filter integrity testing (FIT) is to align the risks as closely as possible with its source. This analysis can identify the root cause of the risk and help the quality assurance staff and operators detect the occurrence of a particular deviation. Additionally, the analysis also helps define the adapted level of training to reduce operator mistakes.

Magnus Stering has written an interesting article for Pharmaceutical Processing about the risk assessment of filter testing.

The article identifies risks for achieving a higher level of FMEA for FIT and for improved quality assurance. It can be accessed here.

Posted by Dr. Tim Sandle

U.S. National Microbiome Initiative

Last Friday the White House announced that it was creating a National Microbiome Initiative to bring together scientists to study microbial diversity associated with the human body and our environment. The move will inject $121 million/year into microbiome projects from federal agencies as well as an additional $400 million from other institutions, including the Gates Foundation. In addition to monetary support, the NMI will foster collaborative studies, interdisciplinary research and comparative studies.

Microbiomes are the communities of microorganisms that live on or in people, plants, soil, oceans, lakes, rocks, and the atmosphere. Recent discoveries have generated a new view of the biological world, one that recognizes that plants and animals are actually meta-organisms containing one or many microbial species. Inanimate surfaces, from rocks to keyboards, are likewise swarming with microbial life.

These microbial communities help define the health and integrity of their living or inanimate hosts. Microbiomes influence the behavior of diverse ecosystems, with effects on human health, climate change, food security, and other factors. Imbalanced microbiomes have been associated with human chronic diseases such as obesity, diabetes, and asthma; local ecological disruptions such as the “dead zone” in the Gulf of Mexico; reductions in agricultural productivity; and disruptions in weather and atmospheric conditions related to climate change.

Despite the exciting progress that has already been made in microbiome science, the knowledge and tools necessary to manipulate microbiomes in a directed manner are lacking. The NMI will focus on comparative study of microbiomes across different ecosystems to seek organizing principles that shape all microbiomes. Understanding these principles are necessary to develop approaches to reliably alter microbiomes to benefit individuals, communities, and societies.

Specifically, the NMI will have three goals, which were developed through a year-long fact-finding process that involved Federal agencies, non-government scientists, and a broad community of citizens. These goals are:
  1. Supporting interdisciplinary research to answer fundamental questions about microbiomes in diverse ecosystems.
  2. Developing platform technologies that will generate insights and help share knowledge of microbiomes in diverse ecosystems and enhance access to microbiome data.
  3. Expanding the microbiome workforce through citizen science and educational opportunities.
See: Announcing the National Microbiome Initiative

Posted by Dr. Tim Sandle

Thursday 26 May 2016

New National Quality Standard for Healthcare Associated Infection (QS 113)

A new standard has been issued for U.K. health services. This quality standard covers organisational factors in preventing and controlling healthcare-associated infections in secondary care settings.

Organisational factors include management arrangements, policies, procedures, monitoring, evaluation, audit and accountability.

Secondary care settings include hospital buildings and grounds; inpatient, day case and outpatient facilities and services; elective and emergency care facilities; and hospital maternity units and services.

For further details on the revised standard, see NICE.

Posted by Dr. Tim Sandle

Wednesday 25 May 2016

FDA - Labelling for Biosimilar Products

The principal components of therapeutic biological products are large, complex molecules like monoclonal antibodies and cell signaling proteins. The nature of biological products creates unique challenges that generally do not exist with small molecule drugs. For instance, unlike small molecule drugs made through chemical synthesis, biological products are produced in living systems, such as microorganisms, plant cells or animal cells.

In relation to these products, the U.S. FDA has issued new guidance on how they should be marketed and labelled.

A draft guidance for industry has been produced, which can be accessed here

Posted by Dr. Tim Sandle

9th Edition European Pharmacopoeia - available

The 9th edition of the European Pharmacopoeia, is now available for order.

Each format allows direct access to the EDQM Online Knowledge database. The database provides information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; the chromatogram in pdf format; the links to the reference standard catalogue number; the trade names of some reagents, such as chromatography columns and biological kits; and access to the list of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) that have been granted for this substance.

For more details see: EDQM

Posted by Dr. Tim Sandle

Tuesday 24 May 2016

European food microbiology legislation scheme

The European food microbiology legislation scheme is designed for laboratories that examine foods for compliance with Regulation (EC) 2073/2005 and subsequent amendments.  It has recently been updated.

The European food microbiology legislation scheme assesses the participants’ ability to:

Test and interpret laboratory results in accordance with EU food safety
Process hygiene criteria

The samples are simulated foods to be tested for compliance with either the food safety or the process hygiene criteria.

A list of the updates can be found at the Public Health England site here.

Posted by Dr. Tim Sandle

Friday 20 May 2016

Objectionable Microorganisms

An objectionable organism is one which can either cause illness or degrade the product thus making it less effective. But how to define what is an objectionable organism?

Microbiologics have an interesting discussion paper on the subject. Here is an extract:

A manufacturer can detect objectionable organisms in its product by:

1.Performing tests for specified microorganisms as described in USP <62>.
2.Identifying all suspicious colonies growing on agar plates used in microbial enumeration tests. To find out more about microbial enumeration tests, see USP <61>.
3.Performing a risk analysis to determine which organisms would be objectionable and then devising a plan for detecting the organisms.

To access the paper, see Microbiologics

Posted by Dr. Tim Sandle

Thursday 19 May 2016

Should You Try New Approaches to Instrument Calibration?

Validation and instrument calibration are a necessity in every manufacturing and production unit. Calibration procedures have witnessed some changes and new techniques have been introduced. New approaches such as instrument diagnostics and calibration analysis have significantly improved efficiency. Read on to know more.


It is essential that instruments and devices used in your company are routinely calibrated to ensure that you get accurate measurements. However, it should be noted that not all instruments need to be calibrated at the same time or with the same frequency. Instrument diagnostics is the practice of analyzing the level of calibration different instruments require and which instruments can be shifted from periodic schedule to on-demand calibration.

While some devices have to be calibrated periodically without fail, the less critical instruments can be monitored carefully to observe if they indicate any change that needs immediate attention, which then should be calibrated as per requirement. On-demand calibration will eliminate hundreds of unnecessary calibrations per year. Instrument diagnostics ensure that efficiency is increased by folds, without compromising on the quality.


Calibration was a manual process and so was documenting. With automation, it became possible to achieve paperless calibration where the data pertaining to calibration can be recorded, stored and documented electronically. Paper is completely eliminated which helps in saving money.

The calibration process can be significantly streamlined by optimizing periodic calibration schedules, synchronizing instrument data in the calibration management system and using documenting calibrators. Paperless documentation allows technicians to access the required information and upload calibration results from any location, at any time. Further, it eliminates the necessity for administrative technicians and staff to manually fill out the data which usually takes a lot of hours. Needless to say, paperless calibration is faster, efficient and streamlined.


If possible, the interval between calibrations can be extended to reduce the overall number of procedures that are performed annually. These extensions are done in a manner that they remain in compliance with company regulations and policies. Calibration analysis identifies those instruments that don’t need to be calibrated as often as the others. This is achieved through an on-going, computer-driven analysis of the available historical data.

Calibration analysis includes safety and quality related instruments which need to be calibrated on a schedule but it has to ensure that the calibrations are done on the right schedule. It doesn’t matter if you calibrate some instruments on a yearly basis instead of calibrating every six months, but you have carefully monitor and check if they are performing as designed without compromising or affecting the quality between calibrations.

Results of Practicing New Approaches of Calibration

A number of critical instruments were observed to study if they showed any tendency to under-performed when the calibrations intervals were extended. All the product-related instruments were studied and depending on the result, they were moved into the ‘on-demand’ schedule. It was ensured that none of the instruments were over-calibrated or under-calibrated. Instrument calibration and diagnostics showed promising results and an increased efficiency by facilitating the following:

Reduced the time spent per calibration by at least 15 minutes, which equated to hundreds of hours saved per thousands of calibrations

Thousands of sheets of paper were saved per year
Over 200 hundred calibrations eliminated every year by extending calibrating intervals

A minimum of 500 hours saved per week due to elimination of manual data entry

Reduction in human errors

At least 30% of instruments (not related to safety and quality) shifted from scheduled calibration to an on-demand schedule, annually saving up to approximately 300 hours.

Author Bio:

Edward Simpson is a seasoned Calibration and Technical Engineer working for RS Calibration Inc. Edward has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and can be contacted anytime for matters related to machines on his email edward@rscalibration.com. He also invites people to visit his company www.rscal.com to learn more about the type of calibration work he does.

UHPLC Workflows for Biotherapeutic Characterization

Advanstar have issued a free e-book relating to Biotherapeutic Characterization.

The introduction of UHPLC revolutionized bio/pharma analytical laboratories and advances in technology promise more for the future. In this e-book, experts explain recent advances in UHPLC, and the basics of glycan analysis. Sample preparation technologies that can increase sample throughput and improve data quality for peptide quantitation are explored. In addition, the characterization of intact antibodies using reversed-phase chromatography is detailed.

The e-book can be accessed here.

Posted by Dr. Tim Sandle

Wednesday 18 May 2016

GMPs for HVAC in non-sterile pharma

The World Health Organization has issued a draft guidance, titled “Supplementary guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms.”

The scope of the document is:

“These guidelines focus primarily on the design and good manufacturing practices (GMP) requirements for HVAC systems for facilities for the manufacture of solid dosage forms. Most of the system design principles for facilities manufacturing solid dosage forms also apply to facilities manufacturing other dosage forms (such as liquids, cream, ointments) and other classes of products including biological products, herbal medicines, complementary medicines and finishing process steps for APIs.”

In terms of the change process, during the consultation on data management, bioequivalence, GMP and medicines’ inspection held in 2015 the possible revision of the guidance for (WHO Technical Report Series, No. 961, Annex 5, 2011) was discussed with the inspectors. It was suggested that in light of the new developments a draft for revision be prepared. This new proposal for revision was drafted based on the feedback received, the new, current trends in engineering and the experience gained during the implementation of this guidance in inspection.

At the same time, the opportunity was used to improve the graphic images and make them more readable in e-version as well as in print.

The document reference is Working document QAS/15.639/Rev.1, and it is dated May 2016.

The document can be found here: WHO

The closing date for comments is July 12, 2016.

Posted by Dr. Tim Sandle

ISO 14004:2016 - Environmental management systems

The newly revised ISO 14004:2016, Environmental management systems – General guidelines on implementation, provides organizations with support to help with the implementation of an EMS. It is designed to complement, but is not limited to, ISO 14001, ISO’s standard for environmental management systems.

For further details, see ISO.

 Posted by Dr. Tim Sandle

Tuesday 17 May 2016

History of ancient viruses

The global spread of an ancient group of retroviruses that affected about 28 of 50 modern mammals' ancestors some 15 to 30 million years ago has been revealed by a team of scientists.

Retroviruses are abundant in nature and include human immunodeficiency viruses (HIV-1 and -2) and human T-cell leukemia viruses. The scientists' findings on a specific group of these viruses called ERV-Fc, to be published in the journal eLife, show that they affected a wide range of hosts, including species as diverse as carnivores, rodents, and primates.

The distribution of ERV-Fc among these ancient mammals suggests the viruses spread to every continent except Antarctica and Australia, and that they jumped from one species to another more than 20 times.

The study also places the origins of ERV-Fc at least as far back as the beginning of the Oligocene epoch, a period of dramatic global change marked partly by climatic cooling that led to the Ice Ages. Vast expanses of grasslands emerged around this time, along with large mammals as the world's predominate fauna.

For further details see:

William E Diehl, Nirali Patel, Kate Halm, Welkin E Johnson. Tracking interspecies transmission and long-term evolution of an ancient retrovirus using the genomes of modern mammals. eLife, 2016; 5 DOI: 10.7554/eLife.12704

Posted by Dr. Tim Sandle

Monday 16 May 2016

New ISO 14644:2016 Part 13 reviewed

ISO 14644-Part 13 ‘Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications’ addresses the subject of cleaning cleanroom surfaces to remove particles (surface, in this context, refers to any solid object, work surface or item of equipment). Cleaning is an essential element of contamination control, and particles can cause significant damage to delicate materials and electronic components.

In relation to this, Tim Sandle has written a paper on the new standard which has been published in Cleanroom Technology. The reference is:

Sandle, T. (2016) Beneath the surface of new cleanliness standard ISO 14644-13, Cleanroom Technology, April 2016, pp27-28

To review a copy, please contact Tim Sandle

Posted by Dr. Tim Sandle

Risks to public health related to communicable diseases at the Olympics

New advice from the European Medicines Agency - "Risks to public health related to communicable diseases at the Olympics."

This takes the form of a new document. ​The aim of this document is to assess the health risks related to communicable diseases and other health threats for European citizens during their stay in Brazil for the Rio 2016 Olympics and Paralympics Summer Games, and the public health implications for European countries after travellers’ return to Europe. In addition, the document assesses the risk of disease importation from Europe to Brazil.

For details, see EMA

Posted by Dr. Tim Sandle

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