Category: Biosafety

Regulatory Standards for Sterility Testing

12th October 2018

Category: Biosafety

By: Daniel Cozens - Biosafety Scientist,

What is Sterility Testing? During the production of biopharmaceuticals, contaminating microorganisms can enter the process at many stages. Once introduced, bacteria or fungi can replicate exponentially, severely compromising the final product. The presence of microorganisms in vaccines and other biopharmaceuticals can over time both spoil the product and pose a major risk to patient health. More

Biosafety Testing Throughout the Drug Development Cycle

12th September 2018

Category: Biosafety

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By: Daniel Cozens - Biosafety Scientist,

Biosafety Testing from Cell Line Development Through to Lot Release For the release of biopharmaceutical drugs onto the market, products must be shown to be safe. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare Regulatory Agency (MHRA) require products are tested for compliance before release. This involves a More

Three Decades of Quantitative PCR

17th August 2018

Category: Biosafety

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By: Ifigeneia Stavrou - Biosafety Scientist,

In April of 1983 while on a late-night Friday “moonlit drive through the mountains of California” to his weekend cabin in Mendocino, Kary Mullis, a researcher at the Cetus Corporation biotechnology company, experienced a “Eureka” moment that would change the world forever (1). The idea made him stop the car on the side of the highway More

Testing for Human Cytomegalovirus

5th December 2013

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

Human cytomegaloviruses (and simian) are members of a virus family that are specifically identified by the biologics safety guidelines as a specific concern. Most recently the 2010 FDA guidelines for testing of vaccine cell substrate included a recommendation that if there is the possibility of contamination with Human and Simian cytomegalovirus then the in vitro More

Leptospira contamination – How to manage risk

27th September 2012

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

Vaccines and Biologics are recognized to be at high risk of contamination by bacteria and viruses. Over many years the risks have been determined and these products are recognized to be among the safest on the market. In the past there have been a number of viral contamination events which have resulted in increased vigilance More

Bovine Virus Contaminationin Cell Banks used in Biopharmaceuticals and Vaccines

25th November 2011

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

The risk of contamination of biopharmaceuticals and vaccines by Bovine viruses has been well recognized. Calf serum was, and in some instances still is, commonly used to supplement the growth media for cells used in production of many vaccines and some biologics. Although “serum-free” media is frequently used today the risk of exposure to bovine More

Massively Parallel Sequencing in Biopharmaceutical QC Testing – Is it too much information?

13th May 2011

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

There is a tendency towards conservatism utilising tried and tested methodologies in the safety and QC testing schemes designed for biopharmaceuticals, rightly so. In the early 1990s PCR was a useful research tool and was beginning to be used in targeted adventitious agent testing in cell lines and products, particularly virus vaccines, because of its More

Coping with New Virus Risks in the Manufacture of Biologics

14th April 2011

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

In June 2009 a new virus was added to the growing list of agents found contaminating Chinese Hamster Ovary cells used in the manufacture of Biologics. Genzyme reported a contamination of CHO bioreactor with Vesivirus (subsequently named 2117); this was the third time such infection of a bioreactor had occurred in Genzyme. This virus which More

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