Biosimilar Manufacturing solution center

31. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

    The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

32. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

    The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

33. The 9 Fastest-Growing Outsourcing Segments 10/21/2025

    Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

34. Takeda Reimagines Biopharma Quality For The Digital Age 10/21/2025

    Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

35. How Lipid Nanoparticles Enable Next-Gen Delivery 10/20/2025

    Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.

36. Streamline Process Development, Digitize Data, And Maximize Your Investments 10/20/2025

    Discover how AI, digital twins, and automation are transforming biomanufacturing by cutting costs, improving quality, and accelerating timelines for smarter, more efficient production.

37. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

    Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

38. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

    This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

39. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

    Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.

40. Fermentation Of Live Biotherapeutic Products In cGMP Environments 10/8/2025

    We follow the journey from master cell bank to large-scale anaerobic fermentation, highlighting the unique needs for working with oxygen-sensitive, strictly anaerobic therapeutic microbes in a cGMP setting.