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. Oral Solid Dosage Formulation And Process Development: A Case Study 12/4/2024

    This case study involves a drug substance currently in the preclinical phase. Discussion includes API physical chemical characteristics, enabling technologies, formulation assessment, and more.

  3. 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.

  4. Enteric Coatings For Oral Solid Dosages: A Short Guide 11/19/2024

    Enteric coatings play a pivotal role for drugs/APIs that need to withstand the harsh conditions of the stomach in order to dissolve in the intestine. This article shares an overview, commonly used excipients, and more.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.