Catalent celebrates groundbreaking for expanded biologics facility

Company to Invest $34 million in facility extension to add a new 2 x 2000L single-use bioreactor system and laboratory space

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, celebrated its groundbreaking for a new $34 million extension to its state-of-the-art Madison (Wisconsin, USA) biologics manufacturing facility on Friday 21 October.

When completed, the additional 22,000 square feet of space will accommodate a new 2 x 2000L single-use bioreactor system, allowing the company to support late-phase clinical and commercial production of up to 4000L batches. The new footprint will also support expansion of analytical and process development laboratories, as well as additional office space.

The groundbreaking ceremony, led by Lieutenant Governor of Wisconsin Rebecca Kleefisch and Catalent President and Chief Executive Officer John Chiminski, marks the beginning of construction at the site that will eventually create more than 100 new jobs.

'I want to thank the company for its continued commitment to Wisconsin by deciding to grow here,' said Lt Governor Kleefisch. 'This expansion will further enhance the Madison region’s leadership position in the pharmaceutical and health industries.'

The Wisconsin Economic Development Corporation (WEDC) has awarded Catalent up to $1 million in state tax credits during the next 3 years. The actual amount of credits the company will receive is contingent upon the level of capital investment in Madison during the 3-year period.

'Our continued investment in biologics capabilities is in direct response to market demand, where underlying growth for large molecules is expected to exceed that for small molecule drugs,' commented Barry Littlejohns, Catalent’s President of Drug Delivery Solutions. 'We are immensely proud of our facility, and the people here in Madison who have helped achieve our customers’ programme milestones and move toward larger commercial programmes,' he added.

Opened in April 2013, Catalent’s Madison facility is the home of the company’s proprietary GPEx cell line technology, used to create high-yielding mammalian cell lines. Catalent provides development, manufacturing and analytical services for new biological entities (NBEs) and biosimilars from the Madison facility.

It was designed for flexible cGMP production, from 10–1000L scale, and non-GMP production up to 250L scale, and features extensive use of single-use technologies and unidirectional flow to maximise efficiency. Manufacturing is supported by integrated analytical, process and formulation development capabilities and separate microbiology and quality control functions.

Work to extend its integrated analytical capabilities was completed in January 2016, and Catalent has also completed investments to expand process development capability at the site, including integration of an Ambr 15 microbioreactor system into its cell line and upstream development process, providing overall reductions in timelines and increases in expression levels.