Featured Editorial

  1. 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. 

  2. 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.

  3. 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.

  4. Process Mapping For More Effective Knowledge Management 2/26/2024

    It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.

  5. Post-Pandemic Planning: Using Direct-To-Patient Deliveries For Supply Chain Management 2/23/2024

    UCB Vice President – Head of Global Clinical Science and Operations Tero Laulajainen gets us up to speed on direct-to-patient (DTP) trials and how UCB is leveraging it today.

  6. When In The Product's Life Cycle Does Continuous Manufacturing Make Sense? 2/1/2024

    This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.

  7. The Impact Of Protocol Design On An IRT System 1/31/2024

    DTP and home treatment studies can get expensive — and be a hassle to patients — if the IRT element isn’t well planned for during trial design. In their SCOPE Summit presentation, Irina Grishina and Kelsey Kern of CSL Behring plan to share their personal anecdotes and lessons learned from both types of trials as they pertain to IRT. 

  8. Donating Surplus Clinical Trial Supplies Is Sustainability's “Low-Hanging Fruit” 1/29/2024

    ClinOps professionals know all too well the waste that occurs with leftover trial kits that are destroyed at the end of the trial. Explore donation as a way to give those kits a second life.

  9. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

    Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

  10. Cryo-Shippers: Challenges, Controls, And Logistics 1/3/2024

    Cryo-shippers are essential for shipping advanced therapeutics, but how do you choose and validate the right one? This article from BMS experts offers insights.