Biosimilar Manufacturing solution center

31. 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.

32. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

    Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

33. Common Manufacturing Challenges For LBP Formulations 4/23/2025

    As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.

34. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

    The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

35. Pharmaceutical Sovereignty: The Resilience We Cannot Outsource 4/15/2025

    Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration. 

36. Transforming Life Science With Remote Equipment Monitoring 4/15/2025

    Life science organizations are shifting to data-driven oversight. Discover how remote monitoring technologies are revolutionizing operational efficiency and innovation.

37. Optimizing TFF And SPTFF For High-Concentration mAb Formulations 4/9/2025

    Discover the critical role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.

38. Selecting A Platform Filter For High Concentration mAbs 4/9/2025

    Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.

39. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

    In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

40. A Closer Look At Buffer Recycling For More Sustainable Bioprocessing 4/8/2025

    Recognizing the unexplored potential to save resources, one researcher realized consumption reduction of up to 50% during a key phase of downstream processing.