Clinical Supply Manufacturing Articles

  1. Strategic Procurement For Emerging Pharmas & Biotechs 2/27/2023

    Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

  2. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

    ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

  3. Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy 9/18/2023

    If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.

  4. 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.

  5. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

    Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

  6. Does Single-use Seem Daunting? Try Starting With Standard Assemblies 7/8/2024

    You might not need to outfit your whole facility to take advantage of single-use technology. Assemblies offer a straightforward path to standardizing equipment.

  7. What's A “Hybrid Externalized” Manufacturing Model? 3/10/2022

    Anthos Therapeutics’ phase 2 antibody candidate abelacimab could dramatically improve the way clinicians treat very common, high-risk arterial and venous thromboembolic events. The company is exercising manufacturing creativity to maintain clinical supply. Anthos CEO John Glasspool shares on the Anthos approach to outsourcing. 

  8. 4 Tips For Advancing Your AAV Manufacturing Plans 1/4/2022

    Tim Kelly, M.B.A., COO of Homology Medicines, a clinical-stage genetic medicines company, shares four lessons his company learned from building a GMP facility and testing and optimizing their novel platform.

  9. The Real Cost Of Poor Quality — And What You Should Do About It 7/30/2024

    It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.

  10. 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.