Optimizing Biologics Testing
Budget, capacity, and strict regulatory requirements can often delay commercialization of the next big breakthrough. How to reduce these risks?
Less than 1% of all drug candidates entering clinical trials reach the market, which means you need a partner with a proven track record. With over 40,000 tests run annually at global biologics testing facilities and 200+ products supported; Charles River can provide comprehensive testing services for a wide range of modalities. These include monoclonal antibodies/recombinant proteins, viral vectors, vaccines, and cell therapies. Count on us to ensure your biologic is safe, effective, and able to pass regulatory scrutiny.
Next Generation Sequencing in Adventitious Agent Testing: Navigating Regulatory Acceptance
Traditional in vivo assays are slow and resource intensive. Next generation sequencing (NGS) offers a faster, more comprehensive alternative for viral detection in biologics development. Join experts Olaf Stamm and Horst Ruppach in a webinar to learn how to implement NGS effectively while aligning with revised ICH Q5A guidelines.
Next level viral safety testing: How to replace legacy testing methods with NGS
Biologics are essential but susceptible to viral contamination, which can threaten patient safety. Traditional detection methods, including in vivo tests, antibody production tests, cell-based assays, and PCR, face challenges due to increased product complexity. This whitepaper explores these limitations and demonstrates how validated NGS technology can enhance viral safety testing.
DownloadPromoting Safe and Effective Gene and Cell Therapies: The Importance of Lentivirus Testing
Lentiviral vectors (LVs) are key in gene therapy but require rigorous testing for patient safety. This webinar will cover LV quality attributes, testing strategies, and compliance with FDA and EMA guidelines. Key topics include titer assessment, impurities, replication-competent virus, and GMP-aligned quality control strategies.
Register hereNext Generation Sequencing for Adventitious Virus Testing: An effective Testing method
Vaccine developers traditionally relied on animal testing to detect adventitious viruses, using in vivo, in vitro, and PCR methods. However, next generation sequencing (NGS) is now emerging as a more effective alternative. Regulatory bodies support NGS for viral safety testing, prompting a shift away from traditional assays.
Read moreMoA Reflective In Vitro Potency Testing for GLP-1R Agonists Poster
This proof-of-concept study investigated if different GLP-1 agonists can activate the reporter system and if this system is robust enough to be validated according to ICH Q2(R2) guidelines to be used for GMP lot release and stability testing. See poster presentation video and download PDF.
DownloadMoA Reflective In Vitro Potency Testing for Vaccines Poster
Learn how to substitute the in vivo methods by in vitro alternatives reflecting the immunogenicity of vaccines. Explore why implementation of 3R principles is imperative for vaccine development when you download this scientific poster.
DownloadReflections from the 2025 Viral Summit & On-Demand Videos
Read the latest viral safety & viral clearance iInsights and observations from industry thought leaders and regulators to learn about ICH Q5A (R2) impact and the future of viral safety. Access exclusive recordings of presentations and panel discussions from the summit.
Learn moreWebinar: Analytical Testing Regulatory Requirements
This expert-led webinar provides a strategic approach to optimizing lot release and stability programs that can help you stay ahead of evolving standards.
Watch here