Biosimilar Regulatory solution center

  1. Application Of A Dual Spiking Strategy In Viral Clearance Studies 2/3/2026

    Explore how an alternative spiking strategy can streamline viral clearance studies, reduce material demands, and maintain compliance while addressing the challenges posed by MLV and MMV.

  2. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

    International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.