Case Studies & Customer Stories

Robust, Scalable Manufacturing

N-Linked Glycan Analysis for Complex Glycoproteins

The Challenge — The client had an established cell line and process for a complex glycoprotein that produced high-quality material but had a low yield and was not scalable. With plans to move into clinical development, AGC Biologics was challenged to develop a robust, scalable manufacturing process for this molecule while addressing the unique project parameters and production requirements. 

Quality by Design

The Highest-Standard Approach to Process Validation for Early and Late-Stage Projects

The Challenge —Develop and validate manufacturing processes for two novel molecules, one in phase 1 development and the other in phase 3.

Get your antibody produced right. On time.

The Challenge — Accelerating the development and manufacture of monoclonal antibodies is critical for reducing the time it takes to move a promising therapy from bench to clinic.  Learn how AGC Biologics can deliver at least 500 grams of monoclonal antibody manufactured under cGMP in just 12 months for €2 million.

Optimizing a Perfusion Manufacturing Process for Commercial Production

The Challenge —Optimize and scale up a bench-scale perfusion manufacturing process for a client developing its first recombinant DNA-based product. The project required the scale-up of a complex process and the development of validated analytics that would support commercial manufacture.

At-Scale LVV Production

Scaling From Cell Factory™ Systems to an iCELLis® 500 Bioreactor without Affecting Critical Quality Attributes

The Challenge —Evolving from the well-established GMP 48L Nunc™ Cell Factory™ (CF) process, identify an effective, replicable, and large-scale lentiviral vector (LVV) manufacturing process to meet the growing manufacturing demand – especially for market application – without affecting critical quality attributes.