From The Editor

1. We're A Virtual Biotech. CDMOs Should Treat Us As A Priority 11/3/2025

   Chief Editor Louis Garguilo says he's sure some readers will smirk at our headline. CDMOs are running a business; they may attempt to treat all customers equally, but they focus where the most financial gain is. That's usually with bigger clients. Nonetheless, according to a very experienced outsourcing professional, there's nothing humorous here at all.

2. FDA Releases Draft Guidance To Accelerate Biosimilar Development 10/31/2025

   New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.

3. Supporting The Next Generation Of ADCs 10/30/2025

   Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."

4. The 9 Fastest-Growing Outsourcing Segments 10/21/2025

   Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

5. AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing 10/10/2025

   At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

6. On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration 9/29/2025

   AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

7. On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing 9/26/2025

   Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

8. On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D. 9/25/2025

   DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.

9. The Death Of A Dogma: David Baltimore And Lessons For Modern Drug Discovery 9/11/2025

   Nobel laureate, David Baltimore passed away at 87 years old, on September 6, 2025. He was widely regarded as a scientific visionary who at just 37, co-discovered reverse transcriptase, an enzyme that flipped molecular biology on its head by showing that genetic information could flow from RNA back to DNA, not just the other way around. 

10. 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.