Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.
Nowadays, many biopharmaceutical operations are outsourced, from R&D to regulatory-driven testing services. These outsourcing activities require a network of partners working hand-in-hand, as a global ecosystem, to bring new and critical medicines to patients in need. Biopharmaceutical companies are increasingly outsourcing to contract research organizations (CROs) and contract manufacturing organizations (CMOs) to not only keep pace with market demands, but also enable rapid expansion of development and manufacturing capabilities, source partners for innovative early stage R&D programs, and achieve greater cost efficiency in resource and expertise utilization.
Read this article in BioPharm International’s Partnerships for Outsourcing May 2021 eBook.
Laurent Lafferrère, PhD, is chief operating officer, and Audrey Brussel*, PhD, audrey.brussel@pathoquest.com, is Viral Safety leader; both are at PathoQuest.
*To whom all correspondence should be addressed.
BioPharm International
eBook: Partnerships for Outsourcing, May 2021
May 2021
Pages: 12–16
When referring to this article, please cite it as L. Lafferrère and A. Brussel, “Challenges When Outsourcing Viral Safety Services," BioPharm International Partnerships for Outsourcing eBook (May 2021).
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
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