Biosimilar Manufacturing solution center

1. 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.

2. 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.

3. 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. 

4. 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.

5. 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.

6. Achieve Higher Targeted Concentrations 9/30/2025

   Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

7. 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.

8. 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.

9. How To Grow CHO Cells Without Cysteine, Tyrosine Feeds 9/19/2025

   Researchers at Pfizer are developing a cell line that synthesizes these amino acids autonomously, which could reduce costs and increase stability.

10. Why FDA's Tough Talk On Foreign Inspections Is More Bark, Less Bite 9/18/2025

    FDA Commissioner Marty Makary has promised to end the so-called "double standard" of announced overseas inspections. Does the agency have the resources?