Clinical Supply Logistic Articles

  1. How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside 10/9/2024

    The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.

  2. Warning To U.S.-Based CDMOs: Don't Get Complacent 9/9/2024

    How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

  3. A 5-Step Approach To Strengthen Clinical Trial Partnerships In Low- And Middle-Income Countries 8/30/2024

    To find suppliers and partners for our clinical trial programs, we need to go beyond just selecting the best offer and then managing them. For virtual organizations in particular, we must strive to be the partner of choice. 

  4. Should You Be Using Unique Container Identification? 8/22/2024

    Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

  5. A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services 8/15/2024

    These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development. 

  6. Clinical Trial QA Strategies In Low- And Middle-Income Countries 8/9/2024

    This author shares key learnings and insights around quality assurance coming out of Gates MRI's vaccine clinical trials in low- and middle-income countries.

  7. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

    A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.

  8. Digitalized Drug Forecasting Minimizes Waste In Clinical Trial Supply Chain 6/5/2024

    Why should pharma companies strive for more sustainable clinical trials? And how can digitalizing drug forecasting reduce waste in the supply chain? J&J Innovative Medicine's Kristel Rens explains.

  9. Adapting Clinical Supply Strategies Through The Phases 5/17/2024

    Phase-appropriate logistics are essential to manage resources efficiently, maintain regulatory compliance, and ensure timely delivery.

  10. Trends To Track: Outbound, Inbound Biopharma Supply Chain Advances 5/10/2024

    Here's an overview of advancements in technology and industry built around biopharmaceutical supply chain and logistics, including packaging and temperature controls.