Catalent signs cell line deal with Japanese CMO

The deal – financial terms of which are not being made public – will see Akita headquartered Unigen use the cell lines to make biosimilars for drug industry customers developing products for the Asian market.

In a separate arrangement Unigen’s owner - UMN Pharma - will provide the Akita-based contract manufacturing organisation’s (CMO) customers with clinical trial, marketing and sales support for biologics made using the Catalent cell lines.

Sven Lee, Catalent’s VP of business development for biologics and GPEx operations, told Outsourcing-pharma.com the firm “will provide the biosimilar cell lines and all the process development protocols that were used by Catalent to achieve the yields of the clones selected for development and manufacturing.​

“We can also provide UMN with onsite training of our process at Catalent’s Middleton, WI facility and later in the new facility in Madison,” he continued

Lee is not concerned that the deal grants a CMO and therefore potential competitor access to Catalent’s technology, explaining that: “Our model is to allow partners to the flexibility of choosing their own manufacturing or to manufacture through a CMO.  In the case of UMN and as Unigen are a subsidiary it made sense they would use this facility​.”

The Unigen agreement differs from the deal Catalent agreed with Japan’s Toyobo Biologics last year​, which saw the Osaka CMO agree to act local marketing partner for the New Jersey firm’s GPEx cell line engineering technology.

Biologics​

Catalent’s GPEx cell line production technology has been the focus on a number of agreements this year.

In April​, Nascent Pharma contracted Catalent to develop manufacturing cell lines for its candidate antibody-based brain cancer treatment Pritumumab and also produce supplies of the biologic for clinical trials.

More recently​ the firm partnered with Cevec Pharmaceuticals – owner of a protein expression platform based on human primary aminocytes – to offer drug industry customers a range of cell line development services.

These deals – and the agreements with both Unigen and Toyobo – fir with Catalent’s efforts to build its biologcs offering, which has seen it start ramping up manufacturing capacity by building a new facility in Madison, Wisconsin in December last year​.

The site – work on which is ongoing - will be an addition to Catalent’s existing biomanufacturing plant in neighbouring Middleton​.