Industry Insights

31. April 2025 — CDMO Opportunities And Threats Report 5/8/2025

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

32. A Road Map For PAT Monitoring And Control 5/8/2025

    Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.

33. Is Early Automation The Key To Scalable Cell Therapy Manufacturing? 5/8/2025

    Picking which phase to introduce automation has serious implications, and the calculation is unique for every product. Here are some important considerations.

34. Hard Lessons In Parenteral Automatic Visual Inspection 5/7/2025

    Complex problems can have simple solutions. That's what a team at AstraZeneca found when they set out to reduce false rejection rates in vials containing mAbs.

35. The EU Biotech Act Has Been Delayed — Here's What That Means 5/7/2025

    First due at the end of 2025, the act has been delayed until late 2026, which suggests key issues that many say hobble innovation will go unaddressed for longer.

36. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

    The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.

37. Addressing Human "Error" In Pharma Manufacturing 5/7/2025

    Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.

38. PheWAS Is Your Friend 5/7/2025

    Discovery and preclinical development expert Stephen Pinkosky, MD, Ph.D. explores the resurgence and growing impact of PheWAS and multi-omics in drug development.

39. Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis 5/6/2025

    Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.

40. Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis 5/5/2025

    Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.