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12 BioPharm International eBook May 2021 www.biopharminternational.com Challenges When Outsourcing Viral Safety Services Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems. N owadays, many biopharmaceutical opera- tions are outsourced, from R&D to regulato- ry-driven testing services. These outsourcing activities require a network of partners work- ing 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 part- ners for innovative early stage R&D programs, and achieve greater cost efficiency in resource and expertise utilization. With an increasing drive of biopharma companies to develop new and innovative biologics, particularly in the cell and gene therapy space, the demand for viral safety testing services has seen an exponential rise and is expected to hit $7.25 billion by 2027 (1). Traditional approaches to assessing viral safety, still considered the workhorses of the industry, have included both cell- and animal-based testing strategies, as well as a number of aging molecular-based approaches such as polymerase chain reaction (PCR). While these approaches have suff iciently met the indus- try need for decades, they often fail to keep pace with the demands faced with new and innovative biomedicines and/ or have fallen out of favor in light of the 3Rs (replacement, reduction, and refinement of animal testing). The need for rapid and robust testing strategies to ensure the safety of EUGENE - STOCK.ADOBE.COM 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. LAURENT LAFFERRÈRE AND AUDREY BRUSSEL Partnerships for Outsourcing Analytics