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).
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
2 Commerce Drive
Cranbury, NJ 08512