The new ‘HA4 Plant’, located at the company's Takasaki site, about 100km from Tokyo, was completed today, with operations set to commence in the first half of 2016.
The facility complies with GMP in Japan, the US, and the EU, and amongst the plant’s capabilities it has installed a 12,000L bioreactor for recombinant animal cells, which Kyowa Hakko Kirin spokesman Kazuaki Inoue told Biopharma-Reporter.com would be – along with all the biomanufacturing equipment on site – stainless steel.
The size of the bioreactor will allow the firm to realise a larger scale and stable manufacture of biopharmaceuticals, though when asked Inoue said it fell short of Japan’s largest bioreactor for mammalian cells with that title going to Chugai Pharmaceutical, a division of Roche.
The four-storied, 4,000m2 Kyowa Hakko Kirin facility also has capabilities for downstream processing with a new compatible large column purification plant attached.
Pipeline & Potelligent Platform
Inoue was unable to disclose which biopharmaceutical APIs the new plant would manufacture but Kyowa Hakko Kirin currently makes and markets several products for the Japanese and Asian markets. These include ESPO (filgrastim) used to stimulate the proliferation and differentiation of granulocytes, and the enzyme drug Leunase (asparaginase) used for acute lymphoblastic leukemia and made with a modified strain of E. coli HAP.
Furthermore the firm has a pipeline with a number of monoclonal antibody drugs developed using its BioWa Unit’s Potelligent cell line technology which, according to the firm, uses antibodies with low fucose content which are better able to interact with immune cells and are thus more potent than antibodies that contain high amounts of sugar.
Poteligeo (mogamulizumab) has been filed in Japan for peripheral T/NK-cell lymphoma whilst Benralizumab, of which Kyowa Hakko Kirin has the marketing rights in Japan and Asia, also uses the Potelligent technology and is being developed by AstraZeneca’s biologics wing, MedImmune.