Guest Columns

  1. How Generic Pharma Manufacturers Can Rebuild Margins Inside The Four Walls 5/4/2026

    The pricing dynamics for generic drugs turns formerly attractive products into high-volume, low-margin commodities. Lean and Six Sigma in four key areas can unlock efficiencies.

  2. Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative 5/1/2026

    This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

  3. The Stepwise Path Lilly Mapped From Paper To Digital Logbooks 4/30/2026

    Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

  4. Minimizing Regulatory Risk For Biologics Manufacturing Changes 4/29/2026

    Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.