Featured Editorial

1. Mastering Biotech's Insourcing/Outsourcing Trade-Offs 4/10/2026

   Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.

2. Drug-Device Combination Products: 4 Evolving Platforms For 2026 4/10/2026

   Biologic advantage won’t come from better biology alone, but from delivery technology and designing the full experience around patients, providers, and supply chains.

3. Integrate Upstream/Downstream To Reduce Development Risks And Costs 4/8/2026

   Coordinating unit operations can help reduce costs and mitigate challenges in process development. Check out these key takeaways from the Bioprocess Online Live event “Optimizing Process Development Through Upstream and Downstream Integration.”

4. From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations 4/6/2026

   Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.

5. From IV To Subcutaneous: It's Not About Convenience, It's About System Design 4/6/2026

   IV→SC transition extends beyond dose, volume, concentration, and device; it requires integrated system design, not a series of isolated optimizations.

6. New Research: Co-Expression Could Make Plant-Based Systems Viable 4/2/2026

   By co-expressing Protein A with the protein of interest, the work proposes to reduce the abundant cost of chromatography resins with a one-pot purification approach.

7. Quantifying Single-Use Waste Produced During mAb Manufacture 4/2/2026

   Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.

8. From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations 4/1/2026

   The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.

9. The Systems And Choreography Needed For Grade B ATMP Material Transfer 3/31/2026

   Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.

10. Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign 3/27/2026

    The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.