Featured Editorial

  1. Designing Highly Agile Bio/Pharma Manufacturing Facilities 4/5/2024

    In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules. 

  2. Best Practices For Clinical Supply Chain Management In Rare Disease Trials 3/27/2024

    A supply chain pro discusses three of the greatest challenges in clinical trial supply management for rare diseases and strategies to overcome them.

  3. Quick Takes From Takeda Austria's Annex 1 Rollout 3/25/2024

    At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.

  4. How To Prevent And Manage Temperature Excursions In Clinical Trials 3/20/2024

    Temperature excursions can have devastating effects on drug product for clinical trials. Here are some ways to avoid them and protect the cold chain.

  5. Process Development With “The End In Mind” For Startups 3/20/2024

    We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

  6. What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production 3/8/2024

    Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.

  7. The Key Differences Between Expanded Access Programs And Investigator Sponsored Trials 3/6/2024

    Expanded access programs (EAPs) and investigator sponsored trials (ISTs) play significant roles. While both aim to provide patients with access to investigational therapies, they operate under distinct frameworks and serve different purposes. Understanding their differences from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.

  8. Do ClinOps Professionals Understand The CAR-T Supply Chain? 3/4/2024

    Lee Clough RN, HP, of Novartis talks about the importance of understanding the nuances associated with collecting and shipping autologous material (i.e., CAR-Ts) for clinical trials. 

  9. Green Gains In Biopharma Without Closing Facilities? 2/29/2024

    Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.

  10. Comparability Considerations For mRNA Product Development 2/28/2024

    Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.