- J.POD® 1 US PROVIDES UNIQUELY FLEXIBLE CGMP MANUFACTURING OF KILOGRAMS TO METRIC TONS OF BIOLOGICS THERAPEUTICS
- J.POD® FACILITY EXPANDS JUST – EVOTEC BIOLOGICS’ CAPABILITIES INTO COMMERCIAL BIOLOGICS MANUFACTURING AND ADDS LATE STAGE CLINICAL DEVELOPMENT AND COMMERCIAL SUPPLY FOR BOTH SMALL AND LARGE QUANTITIES OF DRUG SUBSTANCE
Hamburg, Germany, 11 August 2021:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced the opening of the company’s late-stage clinical and commercial biologics cGMP manufacturing facility (J.POD® 1 US) in Redmond, Washington. The innovative cGMP biomanufacturing facility is the final step in Just – Evotec Biologics’ J.DESIGN platform that integrates data analytics and machine learning through all activities involved with the discovery, development, and manufacture of biologics. This includes design of discovery libraries (J.DISCOVERY™), molecules (J.MD™), processes (JP3®) and the manufacturing facility, J.POD®.
The facility employs J.POD® technology that uses autonomous clean rooms to run small, highly intensified production processes, thereby reducing the cost of biologics manufacturing.
Unique in the industry, the 130,000 square foot J.POD® facility was designed with improved environmental sustainability and a dramatically compressed construction time compared to traditional biologics manufacturing. The site includes dedicated quality control and process development laboratories for both clinical and commercial products, a warehouse, and collaborative office and meeting spaces for approximately 200 employees at full capacity.
The innovative “manufacturing ballroom” and clean rooms provide intensified fed-batch or continuous processing up to 1,000 L scale, delivering high quality clinical or commercial grade drug substance from a few kilograms to metric tons.
Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: “Evotec’s mission is all about access to innovative, highly effective medicines. The opening of J.POD® 1 US marks a big milestone for our Company and our partners. With this uniquely flexible manufacturing facility, Evotec now has the capabilities in house to not only discover and develop innovative biologics therapies, but also deliver them to the patients who urgently need them. I am very grateful to our Washington-based team at Just – Evotec Biologics who have made this achievement possible right on time – against all odds of the COVID-19 pandemic.”
The facility was built in just 19 months from breaking ground in late 2019, compared to an industry standard of up to 4+ years for a traditional biologics manufacturing facility.
Dr James Thomas, Executive Vice President, Global Head Biotherapeutics for Just – Evotec Biologics commented: “The speed in which the facility was built, and the flexibility of the manufacturing capability delivers on our mission to design and apply innovative technologies to create global access to biotherapeutics. The J.POD® 1 US facility completes our end-to-end drug discovery and development platform, so we can now partner at every stage of the biologics value chain. This important capability supports our commitment to stand prepared with our leading technology, resources and experience to battle future pandemics if needed.”
Just – Evotec Biologics’ existing Seattle facility, which includes discovery and development labs and an early clinical phase manufacturing plant, will continue to operate as an integral part of Just – Evotec Biologics’ J.DESIGN capabilities.
Designed for improved environmental sustainability, the J.POD® facility will use less water, electricity and chemicals compared to conventional facilities; providing a more sustainable approach to large scale manufacturing of biologics.
Dr Leslie Alexandre, President and CEO of Life Science Washington commented: “Just – Evotec Biologics’ J.POD facility brings new, highly innovative, commercial scale manufacturing capabilities to our industry, with the flexibility to produce small and large quantities of drug substance for biotech companies locally and around the globe. I am thrilled to see the vision of Jim Thomas and his superb team at Just come to fruition here in the greater Puget Sound, bringing much needed additional manufacturing capacity to our region and many new jobs. The J.POD facility will contribute to the commercialization of some of the most important, life-saving products delivered through biotechnology.”
At its two sites in Washington state, Just – Evotec Biologics currently employs more than 250 highly skilled workers, and is expected to grow to approximately 300 by the end of 2021. The first manufacturing runs for a valued partner, the U.S. Department of Defense, are due to be initiated in November 2021.