Futureproofing Viral Safety: Global Perspectives from an Educator, Supplier, and Biosafety Expert

Viral clearance is the final safeguard for patient and product safety, but evolving regulations, complex modalities, and sustainability demands call for new approaches. In this webinar, you’ll learn the complexities of viral clearance from a CASTL educator, then hear from Avantor and WuXi Biologics about proven data, alternative detergents, and emerging technologies shaping bioprocessing.

Register Free: https://www.biopharminternational.com/bp_w/futureproofing

Event Overview:

In biopharmaceutical manufacturing, viral clearance is the critical safeguard protecting both products and patients. With regulatory shifts, complex modalities, and growing sustainability demands, the industry’s approach to viral safety is rapidly changing. In this webinar, a CASTL educator will explain what viral clearance is. In addition, Avantor will introduce a novel, regulatory-compliant detergent designed to replace Triton™ X-100 without compromising protein stability—even in sensitive molecules like bsAbs. WuXi Biologics will also share over a decade of viral inactivation data, benchmarking Triton™ X-100 alternatives and exploring the future of viral safety technologies.

Key Learning Objectives:

• Hear about viral inactivation insights backed by over 10 years of data
• Learn about emerging technologies reshaping viral clearance strategies
• Learn about sustainable, GMP-ready alternatives for futureproof safety

Who Should Attend:

• Process developers
• MSAT engineers
• Downstream manufacturing engineers

Speaker:

Hardik Upadhyay
Site Leader
CASTL

Hardik Upadhyay has worked in the biopharmaceutical manufacturing industry since 2016, specializing in operations management, training, and process optimization. As a trainer and site manager at CASTL’s Charlottetown training facility, he instructs learners in critical procedures and processes to minimize errors, improve productivity, and ensure compliance with quality management systems. Upadhyay originally trained as a pharmacist, completing a Bachelor of Pharmacy at RGTU University and post-grad work in pharmaceutical research and development at the Toronto Institute of Pharmaceutical Technology. He received his certified training professional designation through Quality and Qualifications Ireland (QQI).

Victor Melendez-Colon
Senior Director, Applications
Avantor

Victor Meléndez-Colón, PhD, earned a Bachelor of Science in Chemistry from the University of Puerto Rico, a PhD in Biochemistry and Medicinal Chemistry from Purdue University, followed by a post-doctoral experience with the National Health Institute. Meléndez-Colón worked for Bristol-Myers Squibb, Amgen, AstraZeneca, and Takeda in the biopharmaceutical arena, dedicated to the breakthrough of therapies within their quality, process development, and MS&T departments. He has supported multiple critical technology transfer projects, analytical method development, process and cleaning validations, and manufacturing process improvements. As a recognized expert in raw material attributes and data digitalization, Meléndez-Colón served as chemistry, manufacturing, and controls (CMC) champion of products within global operations to drive pipeline progression, as well as enable successful clinical and commercial performance qualification with successful regulatory approvals. Most recently, he entered a prevalent CDMO position as technical and production business expert in customer service, handling the development of simultaneous cell & gene therapeutical processes from multiple prestigious companies.

Shanshan Wu
Associate Director, Biosafety Testing
WuXi Biologics

Shanshan Wu has accumulated over 10 years of experience in viral clearance studies. She heads the Viral Clearance Study Department within WuXi Biologics Biosafety Testing, leading a team of over 100 dedicated scientists to provide viral clearance services for IND and BLA filing. As team leader, she has monitored over 1,000 IND and 150 BLA viral clearance studies and, as study director, personally oversaw more than 100 viral clearance studies. Her extensive knowledge of viral clearance technologies and significant experience with regulatory filings is an asset. She holds a master’s degree in Biochemical Engineering from Nanjing University of Technology.

Register Free: https://www.biopharminternational.com/bp_w/futureproofing