Material Handling Featured Articles

  1. A Guide To QbD For Small Molecule Drug Product Manufacturing Excellence 11/13/2024

    Leveraging the quality by design (QbD) approach to achieve manufacturing excellence is game-changing. This article shares QbD principles, benefits, and successful case studies.

  2. 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.

  3. 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.

  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. Technical Considerations For Selecting Softgels As An Oral Dosage Form 8/21/2024

    The unique characteristics of softgel capsules can play a pivotal role in the success of a drug. By addressing stability and shelf-life challenges, softgels have become a valuable tool for manufacturers.

  10. Aligning Pediatric Patient Needs With Drug Development Success 8/15/2024

    Executive Director of Pharmaceutical Sciences Srinivasan Shanmugam, Ph.D., discusses pediatric patient compliance, regulations impacting trial access, excipients within formulations, and more.