Recovery of Biological Products XIX (RXIX)
Join us in-person at the Rome Cavalieri, Waldorf Astoria Hotel, in Rome, Italy for the Recovery of Biological Products XIX conference where Just-Evotec Biologics will be presenting its research.
- Lisa Connell-Crowley, VP Process & Product Design at Just-Evotec Biologics
- Rob Casey, Director Technical Operations at Just-Evotec Biologics
- Megan McClure, Principal Scientist Process Science at Just-Evotec Biologics
Advancing Manufacturing Technology Through a Flexible J.POD® Facility
At Just – Evotec Biologics, the need to deliver low-cost, high quality biopharmaceutical manufacturing is driven by our mission to dramatically increase global access to biologics. Accordingly, we have developed an integrated technology platform, J.DESIGN™, to operationalize our technology efforts for affordable biologics. J.POD®, an integral part of J.DESIGN, is a deployable manufacturing technology that exploits process intensification using single-use systems in modular and autonomous cleanrooms. This advanced manufacturing technology coupled with J.POD’s modular design allows for flexible and parallel production of multiple biological products within the same facility. This new approach to facility design has positioned J.POD facilities to manufacture therapeutics in agile response to COVID-19 and other future pandemics. Our first commercial facility in North America, J.POD 1 US, launched production in September 2021 and now manufactures therapeutic proteins including antibodies. This presentation will include J.POD 1’s startup timeline with a discussion of key milestone activities. The drivers for facility design will be presented in the context of capacity and cost modeling, including managing risk and uncertainty through deferred capital investment. A comparison between a flexible facility design and a traditional stainless-steel facility, based upon differences in facility costs and speed of construction, will be highlighted, including facility performance and capacity. We will also discuss our project to implement fully integrated continuous manufacturing in J.POD 1 and future facilities, an approach which is informed by cost analysis and facility footprint considerations. Further discussion topics include our emphasis on single-use technology operating as fully/functionally closed systems, sustainability initiatives, and the regulatory challenges associated with process and facility design concepts for operating a multi-product facility. The presentation will close with facility information and a project update about J.POD 2 EU that starts construction in Toulouse, France this year, as part of Just – Evotec Biologics’ strategy for a global network of flexible facilities that utilize an integrated technology platform approach.
Presented by Robert Casey, Director Technical Operations at Just-Evotec Biologics
Considerations for Viral Filtration in an End-to-End Continuous Process
Integrated, end-to-end continuous processing presents challenges to the viral filtration operation to maximize filter throughput while ensuring viral safety. Continuous virus filtration over many days requires higher loadings to maximize filter utilization and minimize system manipulations, such as filter change-outs, to reduce process risk. However, high filter loadings and long process times create challenges in evaluating the viral clearance capabilities of the viral filter. Assessment of viral clearance to support continuous viral filtration may require studies spanning over several days, as well novel virus-spiking strategies. This type of assessment is needed to adequately demonstrate a high level of viral clearance while not overloading the filters with virus in a manner not representative of manufacturing operations. This presentation will include small-scale screening data for different viral filters to identify those filters that can process large volumes over long operating times, followed by implementation of one of these filters at scale in a continuous process. Additionally, the use of virus surrogates and alternative spiking strategies demonstrating high levels of viral clearance will be presented.
Presented by Megan McClure, Principal Scientist Process Science at Just-Evotec Biologics