Featured Editorial

1. FDA Report Details FY24 Inspections, Shows Big Uptick In Key Countries 8/29/2025

   The 2024 Report on the State of Pharmaceutical Quality shows the agency's efforts to normalize post-pandemic oversight under the previous administration.

2. Unpacking Pfizer's Advanced Process Control Platform For Upstream Ops 8/29/2025

   Pfizer's advanced process control platform gives modelers more dexterity compared to default controllers, thus speeding up process development.

3. The OBBBA: Biopharmas Unlock R&D Expensing, Global Tax Efficiencies 8/28/2025

   Biopharma innovators may soon see major tax breaks thanks to the One Big Beautiful Bill Act (OBBBA). The new legislation introduces targeted tax incentives designed to strengthen domestic R&D and capital investment.

4. Single-Use Standardization Starts At Home 8/28/2025

   During a Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up," panelists discuss a way forward for the industry to unlock the true flexibility and promise of single-use technology.

5. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

   The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

6. Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured 8/21/2025

   An element of the 2025 BioPlan Associates annual report and survey took Chief Editor Louis Garguilo by surprise. The report intimates that biopharmaceutical manufacturing faces a fractured CDMO market. Despite solid data to back that assertion up, Garguilo presents a very different view, one based on what many readers have expressed.

7. Calculating The Right In-House/Outsource Mix For ADC Manufacturing 8/21/2025

   Antibody-drug conjugate innovators often question whether to outsource manufacturing activities or bring them in-house. Here are some key considerations.

8. Unlocking The Pharmacological Potential Of Antibodies 8/20/2025

   Abalone Bio's CEO and co-founder, Richard Yu, Ph.D., explains the company's Functional Antibody Selection Technology (FAST) platform and its approach to developing a pipeline of G protein-coupled receptor (GPCR) mAbs.

9. Report: Nearly 40% Of Biomanufacturers Eyeing Continuous Processing 8/19/2025

   Continuous perfusion manufacturing came about before the technology was mature enough to support it. Now, new data suggests an inflection point in the status quo.

10. Advancing CAR T Cell Therapy with Logic Gate Engineering 8/19/2025

    Logic gating applies Boolean logic principles to CAR T cell design to improve precision and minimize collateral damage.