Charles River

Scientific experts Katarzyna Darmochwal, PhD, and Carmen Sweeney, PhD, discuss the latest regulatory expectations for the analytical testing of biologics products. They explain why regulatory success depends not only on compliance, but also on the precision, reliability, and depth of scientific understanding behind every test method.

With regulators embracing next-generation sequencing, how will the ICH Q5A(R2) guidelines reshape viral safety strategies for gene and cell therapies?

Ensure the stability, compliance, and success of your biologic with comprehensive CGMP cell banking and characterization services. Protect your process from start to finish with expert support and proven solutions.

This brochure will expand on our NGS testing services to biopharmaceutical and biotech companies, including viral contamination testing and genetic characterization of cell lines, bulk harvests, virus seeds, and raw materials used for production of biologics including cell and gene therapy products.

Early potency assay development and MOA understanding are critical for ATMP success. Delays can increase costs and risk failure, but recent advances highlight the need for timely, validated approaches to ensure regulatory and commercial success.

Join on June 3-4 in Cologne, Germany to gain insights from leading regulatory authorities, academics, and industry practitioners who define how biologics, vaccines, and advanced therapeutic medicinal products (ATMPs) are evaluated. Discover the latest technologies, learn best practices, and understand how to design an efficient manufacturing process.

NGS-Based Viral Safety Testing for ATMPs: Mandatory or Just an Option?

Characterization and Release Testing for AAV Therapies – the Importance of Empty/Partial/Full Capsid Analysis and its Impact on Potency

Learn highlights from the 2024 event, including new strategies for viral clearance and NGS applications for viral safety testing.

Cell banking and cell line characterization experts are sharing why HEK293 cells are important for viral vector production for CGT products.

Your biologic can only be as successful as the cells behind them. Learn about our full spectrum of CGMP cell banking and cell line characterization services.

When complexities of developing donor-derived cell therapies are considered, NGS emerges clearly as a better, cost-effective yet regulatory-compliant solution.

Thursday July 22, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST Learn how to detect replication competent virus in your gene therapy and what regulators are looking for when testing viral vectors.