Executive Summary
Comprehensive analytical testing is essential to advancing biologics and advanced therapies. This webinar provides an overview of Minaris Advanced Testing’s integrated capabilities, including biosafety testing, viral clearance studies, product characterization, stability programs, and GMP lot release testing. Watch to learn how coordinated analytical
Key Takeaways
– Scope of analytical services across modalities
– Integrated viral clearance and biosafety testing
– Stability and product characterization support
– GMP lot release testing capabilities
Watch the full webinar to explore our full biosafety testing portfolio and capabilities.
About This Webinar
Biologics and advanced therapies require complex analytical strategies to ensure safety, potency, purity, and regulatory compliance. As modalities evolve, sponsors must align biosafety testing, viral clearance validation, and product characterization within structured GMP frameworks.
In this session, Minaris Advanced Testing outlines its analytical services supporting monoclonal antibodies, viral vaccines, and advanced therapies. Topics include viral safety and viral clearance studies, stability program design, analytical development, and GMP lot release testing.
The discussion highlights how integrated analytical services improve data integrity, streamline regulatory submissions, and reduce risk during clinical and commercial manufacturing. By consolidating analytical development and testing within a coordinated quality system, sponsors gain greater visibility and control across the product lifecycle.
This webinar provides a practical overview of how structured analytical capabilities support compliant, scalable development.
Who Should Watch This Webinar?
– Analytical development and QC leaders in biologics and advanced therapies
– CMC teams preparing regulatory submissions
– Sponsors requiring biosafety testing and viral clearance validation
– Quality professionals overseeing GMP lot release testing
– Biotech and pharma companies evaluating analytical service partners
Watch nowAbout the speaker
Audrey Chang, PhD
CMC Advisor at Minaris Advanced Testing
Dr Chang has over 28 years of government and industry experience in conducting biological product testing and in managing laboratories. Audrey earned her Ph.D. at the Johns Hopkins University in Biology, and after a post doc at the FDA, joined BioReliance where she held various positions of increasing responsibilities. Prior to joining Minaris Advanced Therapies, Audrey was VP of QC at Vigene BioSciences which was acquired by Charles River Laboratories. In her current role, Audrey provides technical solutions and support to clients for both traditional biologics and novel modalities. Audrey has always had a passion for driving innovative products to commercialization and is happy to bring her experience to the testing division at Minaris Advanced Therapies.