Featured Pharma Online Editorial

  1. Stage 3a: A Key Indicator For Process Validation Maturity 12/9/2024

    Process validation's stage 3a serves to reconfirm the assumptions made during design space development and is particularly pronounced for new modalities and emerging processes.

  2. 2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality? 12/3/2024

    The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Developing & Manufacturing Oligonucleotides: An Overview 8/22/2024

    An overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides.