Editorial

1. Should We Refocus On The Product, Then Engineer The Process? 10/14/2025

   Logic behind the "process is the product" refrain collapses when you accept that starting material is non-uniform by design. These experts want to rethink a tired cliche.

2. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

   This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

3. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

   Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.

4. Fermentation Of Live Biotherapeutic Products In cGMP Environments 10/8/2025

   We follow the journey from master cell bank to large-scale anaerobic fermentation, highlighting the unique needs for working with oxygen-sensitive, strictly anaerobic therapeutic microbes in a cGMP setting. 

5. Import Product Specifications And Drug Registration Testing For China 10/6/2025

   This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

6. What If We Had Just One Developability Parameter? 10/3/2025

   Research suggests years-long stability studies that gobble up material can be reduced to a single day using milligram quantities.

7. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

   Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

8. What You Should Know About USP's Bioassay Updates 10/2/2025

   The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

9. Automation In The Lab: Lessons From Successes And Setbacks 9/24/2025

   Real-world examples show that, in some labs, manual screenings disappeared altogether, replaced by automated runs that now cover entire departments.

10. Can CHO Bioreactors Be Used For Plant-Based Protein Production? 9/22/2025

    The moss Physcomitrium patens is especially good at producing glycoproteins. Established technology and prior knowledge are helping one company develop new therapies with it.