A New Approach to Virus Safety
Andy Baily at ViruSure GmbH provides an overview
of the new CPMP guidelines on virus safety
and investigational medicinal products.
February 2009 saw the introduction of new regulatory guidance
governing the virus safety of investigational medicinal
biotechnology products (IMPs).
The development of this guideline has enabled
a more pragmatic approach to ensuring virus safety of IMPs,
seated firmly in the principles of risk-based management.
The process of developing the guideline started in 2004
with the publication by the EMEA of a concept letter
detailing the proposed scope of the new guideline.
The need for such guidance stemmed from a lack
of clear regulation regarding the point in development
that full ICH Q5A compliant testing should be applied.
The ICH Q5A guidelines are specifically applicable
to products proceeding into marketing authorisation,
but the requirements for products in clinical development
have never been clearly specified.
[...]
ViruSure is a well-versed CRO offering services in the areas
of virus and prion safety testing for biopharmaceutical products,
cell banking and cell bank characterization services
and in vivo biosafety studies (adventitious agent testing,
tumorigenicity testing, oncogenicity testing) and molecular and
potency testing, all required by pharma and biotech companies
specializing on biological products (e.g. recombinant proteins, vaccines,
human and animal derived biological products, cell based therapies).
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