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).
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
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