Clinical Supply Manufacturing Articles

  1. The Process Map To Ensure Biopharma Raw Materials Supply 8/16/2022

    In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.

  2. 4 Ways Academic Medical Centers Can Capture Greater Value In The Cell & Gene Therapy Industry 8/22/2023

    Academic medical centers (AMCs) are unique in the way academic functions and healthcare delivery services are co-located. With strong research capabilities, access to leading scientists, access to patients, and more, AMCs are uniquely positioned to conduct research and clinical trials, enable process development and manufacturing, and more.

  3. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

    AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

  4. Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs 11/6/2025

    This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process. 

  5. Solving The Leukopak Supply Chain Issue With Cryopreservation 11/25/2024

    Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.

  6. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

  7. 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.

  8. NK Cell Therapies: How Artiva Biotherapeutics Leverages Its "Manufacturing First" Approach 4/24/2024

    We caught up with Chris Horan, Artiva Biotherapeutics' CTO, to discuss natural killer cell therapies and Artiva’s experiences and strategies with its candidate, AlloNK.

  9. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

    Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

  10. 3 Strategies For mAb Manufacturing: How Do You Choose? 3/19/2025

    As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.