Newsletter | September 30, 2025

09.30.25 -- From Single-Use To Continuous Manufacturing: Strategies Shaping Biopharma

Management Strategies For Adaptive Bio And Single-Use Excellence

Single-use technologies (SUTs) offer biomanufacturers faster turnaround, flexibility, and lower contamination risk compared to traditional stainless steel systems. However, to unlock their full potential, CDMOs must apply rigorous, phase-appropriate risk assessments.

 

Balancing Speed, Quality, And Digital Transformations

The pharmaceutical development and technology transfer sector is changing fast, making strategic agility essential for CDMOs to succeed. This presentation will explore the main challenges and opportunities outsourcing partners face in this dynamic environment.

 

Elevating Downstream Process Development With Real-Time Data Monitoring

Learn how real-time monitoring of critical process parameters (CPPs) using Process Analytical Technology (PAT) improves control of critical quality attributes (CQAs), accelerates development timelines, and enables the transition to continuous biopharmaceutical manufacturing.

 

Dynamic Trends Shaping The Future Of Microbial Fermentation

By leveraging innovative methods and technologies, developers can unlock new opportunities, improve patient outcomes, and make a significant impact. Uncover how you can stay ahead of the curve and ensure the success of your future microbial fermentation projects.

 

VIDEO INSIGHTS

Step Inside One Of America's Leading Protein Biologics CDMO Sites

With multiple cGMP manufacturing lines, a flexible uni-flow design, and cutting-edge single-use technologies, the site delivers speed, scale, and compliance for both mammalian and microbial biologics. It also serves as AGC Biologics’ global center of excellence for analytical formulation services, featuring the latest fed-batch and perfusion processes.

 

10 Minutes On Optimizing Upstream Process Development

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

 

OPCU VIDEO FEATURE

Capacity Update April 2025: ADC

This presentation offers a global overview of our comprehensive ADC program, providing developers with full end-to-end support — all under a single, streamlined contract.

 

IN THE NEWS

AGC Biologics Strengthens Single-Use Technology Network, Adds 5,000 L Vessels From Thermo Scientific To New Yokohama, Japan Facility

AGC Biologics' Seattle Site Achieves Successful Multi-Product Inspection By U.S. Food And Drug Administration For Biologics License Applications

SOLUTIONS

Global Services: Large Molecules, Advanced Therapies

Across our global network of facilities, we have successfully manufactured over 250 biologics and more than 400 GMP batches of viral vectors. We've also supported over 30 cell and gene therapy (CGT) clinical trials.

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