Outsourced Pharma Editorial

  1. At INTERPHEX 2026 A Smarter Outsourcing Playbook Comes Into Focus 4/28/2026

    From AI explainability to geopolitical sourcing strategy, the Contract and Outsourcing Exchange Stage at Interphex 2026 delivered a clear message for drug sponsors: the days of passive, transactional CDMO relationships are over.

  2. Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline 4/28/2026

    The EMA's December 2025 draft guideline on expectations for the quality documentation of radiopharmaceuticals replaces the earlier 2007 guideline and reflects significant developments.

  3. Overcoming 3 Key Challenges Of Working With CDMOs For Radiopharmaceuticals 4/27/2026

    Radiopharmaceuticals have a level of operational complexity that challenges traditional outsourcing models. Address these three critical challenges early and intentionally.

  4. FDA Letters Made Public Are Creating New Risks 4/23/2026

    There is a pharma-backed citizen petition challenging the FDA over its new practice of publicly releasing redacted Complete Response Letters (CRLs). It could potentially end in a lawsuit. Chief Editor Louis Garguilo provides early analysis of what is at stake.

  5. Selecting The Right eQMS To Maximize Quality Maturity 4/23/2026

    Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

  6. How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT 4/23/2026

    Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.

  7. FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing 4/22/2026

    The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

  8. Validating Candel's BLA-Ready Analytics Profile 4/22/2026

    The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.

  9. Mapping Candel Therapeutics' Sprint To The BLA Finish Line 4/22/2026

    Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.

  10. The Hidden Operational Cost Contained In Every Small Molecule Portfolio 4/21/2026

    The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.