Production Featured Articles

31. Strategic API Sourcing: Offshoring Vs. Nearshoring For A Resilient Supply Chain 9/25/2024

    Generic drug manufacturers must carefully consider the decision to offshore or nearshore API sourcing. It's not only about managing costs but also about ensuring a stable and reliable supply.

32. FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals 9/11/2024

    The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.

33. Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR 9/4/2024

    Content uniformity is one of the most important release criteria for solid dosage forms. In continuous manufacturing, what process analytical technologies (PAT) are available to measure and assure content uniformity as part of a real time release (RTR) strategy?

34. EMA Issues New Draft Guideline: Chemistry Of Active Substances 9/3/2024

    The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

35. Industry Insights In Isolator Technologies And Aseptic Processing In Pharma 8/30/2024

    Explore an overview of trends and insights in isolator technologies and aseptic processing in the pharmaceutical industry.

36. A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions 8/30/2024

    Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.

37. EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging 8/27/2024

    Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.

38. How To Select An Optimal Chromatography Silica 8/26/2024

    When selecting a chromatography resin, it is important to consider particle size, pore size, surface chemistry, scale, and surface area to help optimize efficiency, selectivity, and quality.

39. Small Scale, Big Impact: The Advantages Of Flexible Pilot Plant Equipment 8/26/2024

    Discover the benefits of flexible pilot plant equipment. Seamlessly scale up your processes, optimize your formulations, and save costs with in-house small-volume production.

40. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

    Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.