Biosimilar Manufacturing solution center

31. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

    Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

32. Bioprocessing Observability: Why Real-Time Monitoring Matters 8/17/2026

    Bioprocessing produces more data than ever, but many organizations still struggle to turn it into action. Better integration can support faster decisions and more predictable performance.

33. The Bioprocessing Industry Has A Digital Execution Problem 8/17/2026

    Digital execution remains a major barrier in manufacturing. Learn how fragmented data, manual decisions, and inconsistent adoption affect the ability to bring complex therapies to patients faster.

34. How Can Biopharma Overcome Digital Transformation Failure? 8/17/2026

    Biopharma understands the promise of digital transformation, but implementation remains the challenge. Learn why organizational structures must evolve to turn strategies into scalable results.

35. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

    The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

36. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

37. In Bioprocessing, Trusted Data Is A Process Variable 8/6/2026

    As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.

38. Are Biopharma Companies Outsourcing Their Ability To Think? 8/5/2026

    Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.

39. Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring 7/22/2026

    Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

40. What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)? 7/20/2026

    Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.