Catalent Pharma Solutions opened a state-of-the-art bio-manufacturing centre of excellence in Madison, Wisconsin, US, in April 2013. Following the inauguration, Catalent relocated its operations and 89 employees from a 43,000ft² facility in Middleton to the new 100,000ft² centre.

The new facility quadruples Catalent's manufacturing capabilities and helps to generate innovative biologic products.

Catalent invested $29m in leasing and equipping the new site. It received $1m in job creation and job training tax credits from the state.

Catalent's Middleton facility details

Catalent's Middleton facility was equipped with biopharmaceutical development and mammalian cell line engineering capabilities. It was also capable of carrying out protein production for clinical Phase I-II trials.

The facility used the patented gene expression (GPEx) technology used for producing stable mammalian cell lines. The technology enables current Good Manufacturing Practice (cGMP) production of biopharmaceuticals.

The Middleton facility also included development laboratories and space for research and development and quality control. It included cGMP manufacturing suites featuring stirred tank bioreactors.

The facility was ideal during the initial growth stages of the company in the early 2000s. It is, however, ageing and its size restricted Catalent's bioprocess capabilities. Relocation was considered as the best solution to address these issues.

Need for expansion of Catalent's facilities

Relocation to Madison was part of several strategic initiatives being undertaken by Catalent to improve its product offerings. Increase in demand for cell-line engineering was one of the main reasons for the decision to relocate.

In 2010, contracts requiring use of the GPEx technology had doubled and were growing by nearly 20% every year. Competition was also increasing in contract manufacturing of biologics. Companies such as ShangPharma, Lonza and DSM were expanding their offerings in the field.

The increase in demand for Catalent's products and manufacturing capabilities, as well as competition from other companies, resulted in a need for more space and a robust infrastructure. In December 2011, the company announced its plans to expand its manufacturing capabilities. The additional capacity provided by the new facility would help Catalent's customers bring their products to the market faster.

Catalent also partnered with Toyobo Biologics to increase its product offering in biologics.

The new Madison facility

The Madison facility was originally built in 2000 for the production of bone-scanning medical devices. It was later operated by GE Healthcare. Catalent retrofitted the facility to its standards.

Designed for cGMP production from 10l up to 1,000l and non-GMP production up to 250l, the new facility features extensive use of single-use technologies and unidirectional flow to minimise the risk of cross-contamination. The facility is equipped with three separate cGMP-compliant production suites.

The Middleton facility employed 200l stainless-steel bioreactors. The new facility shifts the use of single-use bioreactors with capacities ranging from 50l to 100l. This increases Catalent's production capacity for Phase I and II clinical trials.

Single-use bioreactors help to increase the number of batches produced. They provide Catalent with greater flexibility in terms of cleaning and changeover. This flexibility is essential in an environment where Catalent has to work on different proteins supplied by several customers.

The increased capacity from stainless-steel bioreactors helps Catalent to scale up its manufacturing capabilities according to customer requirements.

Catalent installed one single-use bioreactor at the Middleton facility. This enabled employees to familiarise themselves with the system.

Production at the Wisconsin facility

The new facility increases the efficiency and output of the GPEx technology. It uses retrovector technology, which enables accurate transduction of targeted cells. Any kind of complementary DNA can be targeted using the technology to generate a mammalian cell line of customer's choice.

The technology enables generation of stable mammalian cell lines in 4.5 months compared with 18 months using conventional technologies. It is more efficient and reduces costs by halving the development time.