Catalent Madison: Capitalizing on Biomanufacturing Expertise

Mike Jenkins GM Catalent 001 CropCatalent Pharma Solutions – Madison has been busy lately. The expanded 100,000+ square foot biomanufacturing facility is ready for a grand opening on April 26 and last week the biologics group announced an exclusive license to Redwood Bioscience antibody drug conjugate (ADC) technology. I recently caught up with Michael Jenkins, General Manager for the site about the company’s progress and where they are headed next.

 

The Madison site is a prime example of advances in biotech coming from a strong agricultural tradition in Wisconsin. In 1996, the predecessor company was founded as Gala Design to produce pharmaceutical proteins in the milk of transgenic cows. (Gala is Greek for milk.) In 2003, Gala Biotech (previously Gala Design) was sold to Cardinal Health, which was followed by a spin out of the pharmaceutical technologies and services businesses into a new company called Catalent Pharma Solutions in 2007. The roots of the Catalent Gene Product Expression (GPEX®) technology are the tools developed for gene insertion to develop transgenic animals.

 

The founders of Gala had strong ties to the lab of the late Nobel laureate Howard Temin at the University of Wisconsin-Madison and some of the key early patents were licensed from the Wisconsin Alumni Research Foundation. The sale of the company to Cardinal Health is also an interesting. An angel investor in Gala who worked at the Woodstock Illinois site of Cardinal Health sparked the initial conversations between the companies. Jenkins moved to Madison to work at Gala in 2003, prior to the acquisition. Jenkins said over the last ten years “Catalent allowed Gala to become a company that makes products.”

 

One way Catalent has done that is to provide capital for infrastructure. Catalent has 25 sites and the Madison site expansion the largest capital expenditure in 2012. According to Jenkins, “Wisconsin is the only place Catalent can grow living organisms to make Active Pharmaceutical Ingredients.” The facility has increased to 100,000 square feet and incorporates single use technologies for cGMP production from 10 to 1,000 liters. Due to their technology that enhances expression, the company anticipates their capacity will compete well with competitive facilities. Jenkins said they are validating the GMP manufacturing space batches and expect to be manufacturing GMP batches for customers this summer. Catalent is looking to expand the market reach of the site from Phase I and II products to Phase III production based on client demand.

 

The facility expansion requires additional personnel, primarily in quality, regulatory and manufacturing positions. Catalent Madison has grown from ~65 to 89 employees during the expansion and expects to add more as the facility use expands. When asked about where the employees came from, Jenkins said  “Our leaders in manufacturing are all University of Wisconsin  Madison Masters in Biotech graduates.” The breadth of knowledge was noted as a key to succeeding in these operations roles. Jenkins also noted that they have not provided any relocations during the expansion. Having worked in North Carolina, Virginia and Florida, Jenkins said the people here in Wisconsin are as good or better.

 

Catalent also provides their biologics to what Jenkins referred to as “key feeder technologies”, which will allow Catalent to offer customers valuable proprietary solutions beyond those developed at the company. The exclusive license just announced with Redwood Bioscience for their antibody drug conjugation technology is just such an opportunity. Redwood has developed aldehyde tags that allow for site-specific conjugation to proteins, including antibodies. In addition to Redwood, Catalent also has deals with CEVEC Pharmaceutical for access to cell lines with human glycosylation patterns and  Xencor for antibody humanization techniques.

Catalent provides opportunities to collaborate within the organization as well. Since the Madison and Woodstock Illinois sites are less than two hours apart, they leverage each other’s manufacturing and regulatory expertise. In addition, the sites collaborate on new applications of patented technologies, most recently applying blow, fill seal technology to glass vials traditionally used for fill and finish of biologics.

 

Catalent’s investment in the growth of the Madison site is encouraging. When companies see value in biotechnology companies we’ve built in Madison, the community benefits when we are able to attract the resources to continue to grow.