APC and Bavarian Nordic Partnership with 500L Pilot Plant
September 27th, 2018 – APC today announced the completion of a two million Euro (€2M) joint investment with its Client partner Bavarian Nordic A/S.
From early 2017, APC have been developing and testing innovative process platforms for Bavarian Nordic A/S providing upstream and downstream development support, scale up and analytical services for its novel, broad spectrum RSV (respiratory syncytial virus) vaccine candidate, MVA-BN RSV®. Providing scalable solutions from bench to 500 litre pilot scale, so a robust, repeatable and, importantly, cost efficient process can then be transferred and validated to Bavarian Nordic’s own commercial assets in support of this innovative medicine.
The Parties entered a strategic partnership that saw the development and build of a new 500L single use biologics facility at APC headquarters in Cherrywood, Dublin, delivered over ten months from concept agreement. This state of the art facility fully integrates Process Analytical Technology (PAT), Process Modelling and Control Capabilities, facilitating deep process understanding leading to an optimised, robust and transferable process. This 500L scale manufacture process will then be “Tech Transferred” into GMP assets within Bavarian Nordic.
In support of upstream processing the pilot plant will initially employ a Single Use Bioreactor (SUB) system providing flexible and cost-effective solutions for most cell culture growth processes. Addressing the immediate need for a microcarrier culture process tailored bags are being utilised.
Initially downstream elements will include unit operations for cell lysis, clarification and purification to address current project requirements, with the ability to add further equipment as client needs arise. Both upstream and downstream processing are supported by APC’s full suite of biologics analytical laboratories currently focusing on viral titre and impurity analysis.
Mark Barrett, Chief Executive Officer at APC commented “this 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. We pay tribute to our client partner Bavarian Nordic for their support during this challenging project, and, of course, all the scientific endeavour and teamwork of the APC team who have delivered yet again.”
Brian Sall, Senior Vice President, Global Operations, at Bavarian Nordic concludes “the 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 2 study investigating the safety and immune effects of its universal RSV vaccine, MVA-BN RSV in an older adult population.”