Industry Insights

31. ICH Final Q13 Guideline For Continuous Manufacturing: What It Means 12/16/2022

    The International Council for Harmonisation released the final draft of its Q13 guideline for continuous manufacturing. It's yet another signal that global regulators see tremendous potential in CM. Here are the key takeaways.

32. 5 Reasons For Outsourcing Chromatography Resin Lifetime Studies 12/12/2025

    Outsourcing resin lifetime studies accelerates timelines, reduces costs, and minimizes risk. Gain expert support, free up resources, and optimize resin performance without tying up your team or equipment.

33. Prefillable Syringe Plungers: A Solution For Low Temperature Storage

    Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.

34. A Methodology To Support Particle Investigations In Biopharma Products 11/22/2022

    Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

35. EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines 5/6/2025

    The EMA's new draft guideline applies to mRNA vaccines for infectious diseases, providing guidance on manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.

36. 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.

37. MHRA's Compliance Report 3/26/2013

    On February 5, 2013, the MHRA put out an update bulletin on its “Compliance Report”. The Compliance Report from the MHRA began around 2009 when they moved to a risk based pharmacovigilance (PV) inspection process. By Bart Cobert

38. The Value Of Expertise In The Aseptic Fill Finish Of Biologics

    Aseptic fill finish manufacturing is critical for highly valuable biologic drug substances. With vast amounts of time and resources invested upstream, loss-resulting errors at such a late stage can be catastrophic.

39. September 2025 — CDMO Opportunities And Threats Report 10/14/2025

    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.

40. Best Practices In The Design Of A Pharmaceutical Manufacturing Facility 11/6/2024

    A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.