- 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.
ABOUT JUST – EVOTEC BIOLOGICS
Just – Evotec Biologics, wholly owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just – Evotec team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation. Learn more at www.just.bio.
ABOUT EVOTEC SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 3,900 highly qualified people. The Company’s 14 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on Twitter @Evotec and LinkedIn.
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding completion of the offering. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based