Just - Evotec Biologics has developed and proven an integrated continuous biomanufacturing platform. It combines a perfusion cell culture step with a fully connected and intensified downstream process. We manufacture drug substance using hybrid (‘semi-continuous’) or fully continuous (‘end-to-end’) modes of operation using either 500L or 1000L scale single-use bioreactors depending on the amount of drug substance needed.
Our continuous bioprocess platform is designed to produce monoclonal antibody, bispecific antibody, biosimilars and next-generation biologics.
Continuous Biomanufacturing Maximizes Flexibility
Our continuous manufacturing approach is extremely flexible while capable of delivering the high mass outputs more commonly associated with traditional large-scale stainless-steel fed-batch facilities. We have high expressing cell lines and integrated single-use upstream and downstream processing unit operations to maximize process intensification. Our innovative control strategy is enabled by our proprietary automation.
Process Development for Continuous Bioproduction
Just – Evotec Biologics scientists are experienced in process development for continuous biomanufacturing. We perform process development for biopharmaceuticals in pre- and early-phase clinical development. Our expertise extends to converting existing fed-batch processes to our continuous biomanufacturing platform in preparation for commercial launch.
Highest Biologics Product Quality
Within our continuous bioprocess platform, an intensified perfusion cell culture process results in high and consistent viable cell densities. Our process controls and process analytical technologies ensure the cell culture is held in a ‘steady state’ resulting in greater product consistency.
Perfusion cell culture allows cells to be maintained in a healthier state than in fed-batch manufacturing and reduces the leakage of intracellular contents, such as proteases, that degrade biological products. In this way, perfusion cell cultures are capable of delivering the highest biopharmaceutical product quality.
Maximum Bioprocess Productivity
Drug substance manufacturing throughput is ramped up to meet product demand simply by extending the perfusion time and increasing the number of downstream cycles. We have proven that we can significantly increase productivity compared to traditional fed batch processes.
Lowest Biopharmaceutical COGs
Our fully end-to-end continuous bioprocessing strategy can deliver titers of 4 g/L/day or more and can reduce COGs for a monoclonal antibody by as much as 75% for a commercial product1.
We are committed to achieving COGs below US$ 50 per gram, as part of our mission to dramatically expand access to biotherapeutics.
Discover More
- How an Integrated, Continuous, Intensified Approach for Manufacturing Biologics Provides Productivity and Quality Benefits >
- Virtual Roundtable Continuous Manufacturing >
- Challenges in Biomanufacturing and How Just-Evotec Biologics Plans to Overcome The >
- Reducing biopharmaceutical manufacturing costs through continuous processing in a flexible J.POD® facility (Open access article in Drug Discovery Today >