Ex-Shire director to aid Catalent’s shift to commercial manufacturing

The new general manager at Catalent’s facility in Wisconsin says his experience at Baxter and Shire will help the plant transition towards commercial manufacturing.

Contract development and manufacturing organization (CDMO) Catalent has appointed Graham Brearley as general manager of its Madison, Wisconsin facility. With over 25 years’ of technical, operations and business experience in the biopharmaceutical industry, BioProcess Insider spoke to him about his move to a third-party services firm and his vision for Madison – and Catalent – going forward.

Graham Brearley, Ph.D., has been appointed as General Manager of Catalent’s Madison, Wisconsin facility

Bioprocess Insider: What experiences from your previous roles will you be bringing to Catalent?

Graham Brearley: I spent over 13 years at Baxter’s biologics facility in California, and progressed to be the Plant Manager. During that time, the site went through initial start-up, FDA and EU licensure, multiple significant expansions and transitioned from single to multiple products. After that, I spent eight years supporting business development on external due diligence and integrations, as well as special projects such as facility divestitures.  I spent time managing a Contract Manufacturing Organization (CMO) project for a product that was ultimately granted FDA approval.

When the BioScience Division of Baxter was spun off to form Baxalta, which in turn was acquired by Shire, I spent a year as site head (Plant Manager) in Milford, Massachusetts, where we successfully submitted an IND application and gained licensure.

These experiences are directly transferable to the Catalent site in Madison, which is also experiencing growth and transition to become a commercial manufacturing site.

BI: How does working for a biologics CDMO compare to working for an end-user biomanufacturer?

GB: The biggest difference is the number of customers and interactions. Catalent is a patient-centric organization, and we are amazingly fortunate to work on many impactful therapeutic programs.

BI: What changes, if any, are you likely to bring in at Madison?

GB: There is a great history of success and growth here, but as we transition from being a clinical manufacturing facility to adding commercial cGMP manufacturing, we need to keep our focus on patients, as well as customers and our employees. Specifically, training and development, and building on robust business processes for commercial production are high priorities.

BI: What do you think is needed at the site in terms of capabilities, and indeed talent?

GB: I will start with talent, as that is the key. We want to attract, train, develop and retain the very best. For capabilities, we are continuing to innovate our R&D platforms, process characterization capabilities, and manufacturing sciences, and will also explore the potential for additional manufacturing capacity. More innovation, more growth.

BI: Tell me about the integration of Madison with the recently acquired Cook Pharmica facility [in Bloomington, Indiana]. How far has this progressed and how will you hope to encourage this further?

GB: We have a unique opportunity to partner closely with our colleagues at Bloomington and present customers a single, integrated offering that covers the entire process from early development to final, fill-finished drug product. The process of working together is already well under way, and both teams are demonstrating wonderful collaboration, keeping our Patient First culture at the front of all that we do.