Biosimilar Regulatory solution center
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Facility Considerations When Retrofitting Legacy Sites For ADCs
1/26/2026
Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.
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Building Enterprise Resilience From QRM Signals
1/16/2026
Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.
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New Year, New Biopharma: Game Changers We're Betting On
1/15/2026
Digital innovation and regulatory evolution are reshaping biopharma. From AI to breakthroughs in oncology and gene editing, discover the trends and challenges that could define the industry.
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Sterile Injectables: Why Innovation Matters More Than Ever
1/15/2026
New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.
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Three Tips To Put Your Viral Vector On The Path To Regulatory Success
1/15/2026
Gene therapy regulations are evolving fast, creating uncertainty for developers. Discover three strategies to navigate approval challenges and keep pace with changing expectations.
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A Sustainable Future: Phasing Out Animal Testing
1/14/2026
Discover a practical roadmap for replacing animal tests with advanced molecular methods, as well as how regulatory updates and innovative technologies are shaping a sustainable future.
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Enhanced Flow Kit Performance With Leak And PUPSIT Testing
1/13/2026
Sterile drug filtration demands rigorous integrity testing to prevent contamination. Learn how PUPSIT and in situ leak testing strengthen compliance with EU GMP Annex 1 and ensure reliable manufacturing.
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Automated PUPSIT For Drug Product Applications
1/13/2026
Automated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.
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Single-Use Standards Are Maturing, But The Process Remains King
1/13/2026
The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.
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Wetting Recommendations For Successful Filter Integrity Testing
1/12/2026
Discover best practices for hydrophobic and hydrophilic filters, troubleshoot failures, and optimize wetting in stainless steel and single-use systems to ensure process reliability and product quality.