Featured Editorial
-
Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices
7/3/2025
Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.
-
Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification
7/1/2025
A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.
-
How CGT Leaders Are Reducing Failures, Scaling Processes, And Overcoming Regulatory Friction
6/30/2025
Industry leaders share their philosophy on reducing product failure, embracing AI, and building dynamic teams to stay ahead of the curve to bring curative CGT therapies to patients.
-
Sorriso's Path To Oral Biologics Dosing Is Through The Gut
6/30/2025
Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.
-
Why 'Which Is Best?' Is The Wrong Question In CGT Development
6/27/2025
In cell therapy development, the instinct to seek a single “best” option is natural — but in reality, there’s rarely a universal winner.
-
Finding Compatibility In Love And CDMO Partnerships
6/26/2025
Just like people, some sponsor-CDMO partnerships can be matches made in heaven. Others, not so much. See what experts have to say about finding the right CDMO and building a successful partnership together.
-
Five Takeaways from BIO 2025 and Why You Should Stay Tuned
6/26/2025
New chief editor of Drug Discovery Online shares insights from BIO 2025’s global biotech gathering and spotlights the impacts to early-stage drug research.
-
Lonza Bets On Biologics. What's It Mean For You?
6/26/2025
It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will increase its focus on biologics, and “advanced synthesis” including for antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA therapeutics. Will other CDMOs follow suit? What's this say about the future of development outsourcing and our industry?
-
Understanding FDA's New National Priority Voucher Pilot Program
6/25/2025
The FDA's vouchers will be issued to companies addressing health issues in the U.S. and increasing domestic manufacturing, among other criteria.
-
BIO2025 Recap: FDA Reducing Animal Testing, Governor Shapiro On Supporting Biopharma, Practical AI Use
6/24/2025
Bioprocess Online chief editor Tyler Menichiello shares his three key takeaways from the 2025 BIO International Convention.