Liquid Dose Featured Articles

  1. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

  2. The Challenges Of Developing Combination Products 3/13/2026

    Examine the regulatory complexity of combination products and learn how holistic development strategies, early equipment decisions, and representative clinical supply reduce risk and costs.

  3. Optimizing Cryovial Filling And Cryopreservation For Reliable Cell Functionality 3/11/2026

    Discover how controlled-rate, directional freezing maintains functional recovery even with lower DMSO concentrations, supporting consistent cell therapy manufacturing outcomes and enhanced batch reproducibility.

  4. U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact 2/18/2026

    Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

  5. Practical USP <1665>/<665> Guide To E&L Risk Assessment 2/17/2026

    A practical USP <1665> and <665> framework helps manufacturers evaluate and manage extractables and leachables risk, supporting quality, safety, and regulatory compliance.

  6. Key Topics And Trends In Aseptic Filling 1/9/2026

    Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.

  7. FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs 12/11/2025

    The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.

  8. Powering The Next Generation Of Drug Delivery Systems 12/4/2025

    Discover how pharmaceutical extrusion, including aseptic methods, enables advanced drug delivery systems, detailing the critical process controls required for success with complex and novel drug products.

  9. How Do We Reduce Your Environmental Cost Of Ownership (ECO)? 12/4/2025

    By rethinking cleanroom requirements and reducing resource-heavy sterilization steps, manufacturers can significantly lower their Environmental Cost of Ownership and futureproof their operations.

  10. 5 Key Questions On Implementing Pharma 4.0™ Solutions For Fill-Finish 12/1/2025

    Pharma 4.0 leverages IoT, AI, and automation to enhance drug quality. Evaluate your fill-finish line readiness by considering five key questions on modularity, high-risk process automation, and data integration.