Newsletter | November 10, 2026

11.10.26 -- Is Your Microbial Process Ready To Scale?

How To Build Reliable, Repeatable Microbial Processes At Any Scale

Successful microbial manufacturing depends on optimizing strain expression and product purity, maximizing fermentation scale-up and controlling process impurities, and achieving consistently high, predictable midstream yields.

 

Analytical Blind Spots That Derail Microbial Programs Before The Clinic

High refolding yields aren’t enough. Learn how analytical characterization, structural equivalence testing, and optimized fermentation reduce scale-up risk and improve quality.

 

Quality From The Start: Reducing Regulatory Risk And Accelerating Market Readiness

Integrating quality early in biopharma development reduces risk, speeds commercialization, and ensures compliance through inspection readiness and ongoing analytical oversight.

 

VIDEO INSIGHTS

10 Minutes On Building A Scalable Upstream Process

Gain insight into how UPD ensures scalable and compliant processes, facilitates the efficient development of innovative therapeutics, and contributes to molecule development and production.

 

GMP-Ready Platform Processes For Microbial, pDNA, And mRNA Programs

Mario Kraft, Director of Process Development at AGC Biologics' Heidelberg facility, explains how platform processes optimize microbial, plasmid DNA, and mRNA production.

 

SOLUTIONS

Global Microbial Capabilities, Starting At 100 L GMP

With robust GMP-compliant quality systems and a broad range of regulatory qualifications, we are equipped to meet manufacturing demands at any development phase. Our microbial production platforms include both stainless steel and single-use bioreactors, offering flexible batch sizes with capacities up to 3,000 liters.

 

What Does A Friendly CDMO Expert Look Like?

Transparent, collaborative outsourcing reduces supply chain risk and protects IP. Open communication and proactive problem-solving keep development on track and speed commercialization.