Clinical Supply Manufacturing Articles

  1. 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.

  2. 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.

  3. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

  4. U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact 2/18/2026

    Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

  5. 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.

  6. The $122 Billion Question: Can Clinical Trial Supply Systems Keep Pace With Cell Therapy Demand? 5/14/2026

    Cell therapy demand is outpacing manufacturing capacity, forcing clinical supply teams to rethink patient scheduling, production slots, and real-time coordination.

  7. 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.

  8. The Hidden Cost Of Convenience: Single-Use Supply Chain Vulnerabilities And Clinical Trial Continuity 7/28/2026

    Single-use technologies improve flexibility, but overreliance on single suppliers can jeopardize trial continuity. Learn how to build resilience before disruptions occur.

  9. ADC CDMO Selection For Small Biotech 8/31/2026

    Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.

  10. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

    When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.