Cell and Gene Regulatory

  1. A Faster Path To Genomic Medicine Feasibility 3/17/2026

    Life Edit accelerates genomic medicine by comparing five editing modalities, engineering new enzymes, and rapidly pinpointing optimal strategies that boost feasibility, cut risk, and speed clinical progress.

  2. Regulatory Brief: USP 382 Updates 3/17/2026

    As regulations continue to shift, staying current with the latest expectations is essential for maintaining compliance and ensuring patient safety.

  3. FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address 3/17/2026

    For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

  4. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

  5. How Drugs Are Manufactured And Administered 3/16/2026

    Modern medicine includes far more than familiar over‑the‑counter products. Explore how drug composition, formulation, and administration work together to shape today’s therapies.

  6. How To Select The Right Fill-Finish CDMO For Phase I–II 3/16/2026

    Early‑phase programs require flexible, technically aligned fill‑finish partners. Mid‑sized CDMOs offer a balance of agility, infrastructure, and regulatory maturity suited to Phase I–II needs.

  7. Pharma's Guide To Navigating Complex Impurity Compliance And Profiling 3/16/2026

    Evolving regulations require proactive impurity control using trace‑level detection, solid risk assessment, advanced analytics, and ongoing monitoring to prevent compliance issues.

  8. The Challenges Of Developing Combination Products 3/13/2026

    Examine the regulatory complexity of combination products and learn how holistic development strategies, early equipment decisions, and representative clinical supply reduce risk and costs.

  9. Building Harmonized Real‑World Data In Oncology 3/13/2026

    Experts at PMWC 2026 emphasized that regulatory‑grade real‑world data in oncology will require prospectively collected, harmonized datasets that integrate multimodal clinical information.

  10. Where Contamination Control Really Breaks Down In Practice 3/13/2026

    Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.