Leveraging Next-Generation Sequencing (NGS) for Adventitious Agent Testing: Pacira’s Quality Control Strategy and Lessons Learned

A Pacira BioSciences Case Study implementing Pathoquest NGS solution

Pacira develops innovative non-opioid pain therapies, with two commercial products and a pipeline that includes musculoskeletal pain, including its Phase 2 gene therapy candidate for knee osteoarthritis.

As we continue to advance our gene therapy programs, this presentation describes the development of an integrated adventitious agent testing strategy within our advanced gene therapy platform utilizing our HCAd viral vector, with patient safety as the central guiding principle. Consistent with our commitment to adopting innovative methodologies across the product lifecycle, this strategy aims to ensure the highest standards of product safety and viral risk mitigation through robust, science-based analytical approaches.

Traditional in vitro adventitious agent assays have long served as the primary testing method within our programs. However, internal experience identified limitations highlighting opportunities to evaluate complementary technologies with improved sensitivity, reduced susceptibility to interference, and enhanced information content.

To strengthen viral safety assessment while maintaining test integrity, Pacira collaborated with Pathoquest to implement a GMP next-generation sequencing (NGS) assay within a risk-based framework as a complementary method for adventitious agent detection. Recognized by the FDA as an emerging technology with the potential to detect known, unexpected, and novel viral contaminants, NGS offers a broader analytical capability when appropriately validated.

A phased implementation approach, including suitability assessment, analytical qualification, and alignment with internal CMC requirements, enabled the controlled integration of NGS while supporting future scalability across programs.

Presented by Po-Yi Ho, Associate Director / Analytical Development / Cell & Gene Therapies at Pacira Biosciences

Po-Yi is a biotechnology professional with expertise in analytical development for gene therapies, genetic medicines, and advanced biologic products. As Associate Director at Pacira BioSciences, Po-Yi leads analytical strategy and assay development to support product characterization, process development, and regulatory submissions across innovative therapeutic programs. With a strong background in analytical sciences, Po-Yi has contributed to the establishment of robust analytical platforms that support the development and commercialization of next-generation therapies.

Prior to joining Pacira BioSciences, Po-Yi worked across gene therapy and advanced biologics programs at Carbon Biosciences, Ensoma, and Flexion Therapeutics spanning multiple therapeutic modalities, where responsibilities included developing analytical frameworks for product characterization, potency assessment, process development, and advancement of clinical-stage programs. Po-Yi has extensive experience in analytical method development, assay qualification, molecular characterization, and next-generation sequencing (NGS) applications, supporting data-driven strategies for genetic medicine development and regulatory readiness.

Earlier in the career, Po-Yi served as an ORISE Fellow at the CDC, contributing to viral hepatitis surveillance and outbreak investigations through the application of NGS technologies. This experience at the intersection of public health, genomics, and biopharmaceutical development has informed Po-Yi’s approach to advancing analytical innovation in gene therapy and supporting improved patient outcomes.

Followed by a live question and answer session

Sponsored by Pathoquest

Pathoquest, A Charles River Company, is a global CRO specializing in Next Generation Sequencing (NGS)-based Biosafety Quality Control through its iDTECT® assay platform, enabling the rapid and safe release of biotherapies to patients. The company offers validated GMP assays for viral safety testing and genetic characterization of cell and gene therapies, vaccines and biologics. Our testing services are available from facilities located in Paris, France, and Wayne, Pennsylvania.

Your GMP Next-Gen Biosafety Partner. Compliant, Faster, Animal-Free.

Learn more: https://pathoquest.com/