Guest Columns & From The Editor

  1. Engineering Challenges In Designing Pharmaceutical Isolators 7/7/2026

    Designing pharmaceutical barrier systems requires balancing strict cleanliness with practical engineering. Explore key factors for optimizing airflow and ergonomics.

  2. Wondering If Your Org Should Purchase R&D Datasets? 7/1/2026

    Pharma/biotech companies are increasingly looking to access large-scale data sets to fill gaps in their computational biology capabilities. Be prepared for the investment.

  3. Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines 6/30/2026

    Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.

  4. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools 6/30/2026

    Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.

  5. How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale 6/29/2026

    Our latest Cell & Gene Live examined how CGT developers can choose manufacturing models that support long-term commercial success by aligning biology, operations, supply chain, and scalability from the earliest stages of development.

  6. Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression 6/29/2026

    While circular RNA platforms can enhance protein expression, developing effective delivery strategies remains the key challenge to achieving therapeutic efficacy.

  7. FDA Explains How To Respond To Form 483 Observations In New Draft Guidance 6/29/2026

    In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.

  8. Organizing Digital Systems Around Novel Modalities 6/24/2026

    Cell therapies represent an important advancement in our ability to treat difficult cancers, but continued exploration of this new modality will require new digital tools and equipment.

  9. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures 6/23/2026

    A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

  10. Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains 6/19/2026

    Restrictions and fear on the Hormuz Strait have fractured supply chains, especially for primary materials used in pharmaceutical packaging.