Featured Pharma Online Editorial

  1. Peptide Synthesis: New Market Research 11/3/2024

    Peptide synthesis is used to create new vaccines, medications, and enzymes. This article provides an overview of solid phase and liquid phase synthesis as well as new market research.

  2. Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients 10/9/2024

    In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.

  3. Sterility Assurance: The Fundamentals 10/8/2024

    Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

  4. 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.

  5. 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.

  6. 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?

  7. 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.

  8. 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.

  9. 2024 Emerging Trends In Cleanroom Technologies 8/14/2024

    This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more.

  10. VR/XR In Drug Manufacturing: No Longer Sci-Fi 8/13/2024

    Virtual reality (VR) immerses users in a completely simulated environment, while extended reality (XR) is an umbrella term encompassing VR, augmented reality, and mixed reality. These capabilities open up a world of possibilities for drug manufacturing.