Biosimilar Insights

  1. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

  2. How Robotic Isolator Technology Aligns To Annex 1 Principles 4/28/2025

    Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

  3. Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators 4/28/2025

    Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.

  4. Biofluorescent Particle Counters Are Gaining Momentum 4/28/2025

    The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.

  5. CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics 4/28/2025

    CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.

  6. White Raven's Accelerated Path To GMP Certification 4/28/2025

    CDMO White Raven achieved GMP certification using an innovative aseptic filling solution in just 18 months. Discover how meticulous planning and collaboration set a new industry standard for efficiency.

  7. Service Solutions Designed To Help You Gain Speed To Clinic And Market 4/28/2025

    Discover how speed, cost, and regulatory acceptance impact drug manufacturing, as well as learn about aseptic filling challenges and how innovative services can enhance your efficiency and compliance.

  8. What Threatens Biosimilars, How Partnerships Protect Them 4/25/2025

    Bioprocess Online Live’s panel discussion Impact Of The Biosimilars Boom wraps up with a discussion about biosimilar development partnership strategy before reflection on a poll of the audience’s perceived threats to biosimilar strategy. Biosimilars Forum Executive Director Juliana Reed and Celltrion VP of Medical Affairs Hetal Patel, PharmD, MBA offer their closing remarks on continued education, alignment across the healthcare ecosystem, and the shared goal of improving access and affordability through biosimilars.

  9. Biosimilars Cost Control And IP Protection 4/25/2025

    In addition to reflecting on a live poll of our audience, Kashiv Biosciences' Associate VP Kaushal Joshi discusses IP protection and cost control in biosimilars development and addresses audience questions on reference batches and assay development in this segment of the Bioprocess Online Live panel discussion Impact Of The Biosimilars Boom.

  10. Market And Policy Dynamics Impacting Biosimilars 4/25/2025

    In this segment of the Bioprocess Online Live panel discussion Impact Of The Biosimilars Boom, Biosimilars Forum Executive Director Juliana Reed and Celltrion VP of Medical Affairs Hetal Patel, PharmD, MBA address the role of policy and legislation in biosimilar adoption. Market dynamics, competition, and the role of Medicare and Medicaid are explored, as Reed and Patel discuss how policy can drive greater utilization and trust in biosimilars.