Newsletter | August 21, 2025

08.21.25 -- Building Smarter Biologics: cGMP, PAT & Scale-Up Strategies

Is Your cGMP Compliance Ready For The Future?

Biologics manufacturers must remain cGMP compliant to both ensure their products meet safety, quality, and efficacy standards and maintain a competitive edge with the associated cost-saving benefits. Explore how to navigate the challenges of incorporating cGMP standards and foster a culture of product quality throughout all levels of your organization.

 

Unlocking Smarter Downstream Development With Real-Time Data Monitoring

Quality should not be tested into products; it should be built in from the start, by design. Learn how real-time monitoring with Process Analytical Technology (PAT) enhances process understanding and control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.

 

Fast Track: 10 Minutes On Upstream PD Optimization

In this Teach Me In 10 episode, Simina Petrovan explores the roles and responsibilities of upstream process development (UPD) while sharing success stories from the field. Gain insight into how UPD ensures scalable and compliant processes, facilitates the efficient development of therapeutics, and contributes to molecule development and production.

 

Mastering Cell Culture Scale-Up: Shear And Oxygen Mass Transfer

Discover practical strategies for achieving seamless transitions, ensuring the success of your biopharmaceutical manufacturing process. Uncover the critical impact of shear forces and oxygen transfer on cell health, how to evaluate and control key parameters, and strategies to minimize cell damage while maintaining process efficiency.

 

OPCU VIDEO FEATURE

Proveo™: Integrated Solution For ADC Manufacturing

The Proveo™ alliance presents an innovative solution for ADC developers seeking comprehensive end-to-end support. This presentation provides a global overview of the program, highlighting how it offers seamless, integrated support without the complications of managing multiple contracts, allowing for a more efficient path.

 

IN THE NEWS

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

AGC Biologics Selects Cytiva To Provide FlexFactory Platforms In New Biomanufacturing Facility In Japan

SOLUTIONS

Global Manufacturing Capabilities

We combine deep industry expertise, technologies, comprehensive service offerings, and a uniquely customized, client-centered approach.

• Request Information