Contributing Editors

  1. 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.

  2. The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations 12/4/2024

    The building blocks of such successful packaging relationships include a thoughtful approach to quality service agreements, a culture of transparency, and more.

  3. AstraZeneca's Digitally Connected Strategy For API Manufacturing 12/3/2024

    The company's packing in the latest technology at its APICOM facility in Dublin. A key feature is more effective and timely use of process data.

  4. 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.

  5. Are We Witnessing A New "Age Of The CDMO"? 12/3/2024

    Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.

  6. The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond 12/2/2024

    These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.

  7. Embracing An Economic Model For Agile Process Development 11/27/2024

    If AI-led discovery brings the surge in new candidates it promises, will process teams be ready?

  8. Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies 11/25/2024

    The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.

  9. Is The BIOSECURE Act The First Real Step Toward Reshoring? 11/22/2024

    The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

  10. Defining When To Implement Technologies To Support Commercial Growth 11/20/2024

    Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.