Biosimilar Manufacturing solution center

  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. 8 Ways To Drive Resilience In Oncology Drug Supply Chains 5/2/2025

    From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

  3. Using Virtual Reality To Enhance Aseptic Contamination Control 5/1/2025

    Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.

  4. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

    Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Helpful Biosafety Testing Innovations Where And When You Need Them 4/24/2025

    Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.

  10. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.