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The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.
The Applied Process Company (APC) and Bavarian Nordic have completed a EUR 2-million (US$2.3-million) joint investment and have partnered to build a new 500-L pilot-scale single-use biologics facility at APC’s headquarters in Cherrywood, Dublin, Ireland, APC announced on Sept. 27, 2018.
The new facility fully integrates process analytical technology (PAT) and process modelling and control capabilities. The pilot plant will initially employ a single-use bioreactor system and process-tailored bags to support upstream processing. After pilot-scale development, the manufacturing process will be transferred into GMP assets within Bavarian Nordic.
Downstream processing elements will initially include unit operations for cell lysis, clarification, and purification to address current project requirements, with the ability to add further equipment as needed. Both upstream and downstream processing are supported by APC’s biologics analytical laboratories, currently focusing on viral titer and impurity analysis.
Since early 2017, APC has been developing and testing process platforms for Bavarian Nordic to provide upstream and downstream development support, scale-up, and analytical services for that company’s broad-spectrum respiratory syncytial virus (RSV) vaccine candidate, MVA-BN RSV.
“[T]his multi-million Euro investment sees continued expansion of APC’s biologics research capabilities. We are delighted the expansion will enforce our stated mission of ‘accelerating the development of quality, life-changing medicines to patients’. This fully integrated pilot platform will expedite research, provide for a robust manufacture process, and ensure client retains all process knowledge required,” said Mark Barrett, CEO of APC, in a company press release.
“[T]he partnership between APC and Bavarian Nordic has been a key factor for us in accelerating the development of a future robust and cost-effective manufacturing process for the commercial supply of vaccines for treatment of RSV. With a mortality rate on a par with influenza, there is a high unmet medical need for an RSV vaccine for the protection of children, elderly, and individuals with respiratory and circulatory diseases. In March 2018, Bavarian Nordic reported positive clinical data from its 421 patient, Phase [II] study investigating the safety and immune effects of its universal RSV vaccine, MVA-BN RSV, in an older adult population,” added Brian Sall, senior vice-president, Global Operations, Bavarian Nordic, in the press release.
Visit APC at Stand 9B71 at CPhI Worldwide in Madrid, Spain on Oct. 9–11, 2018.