- THE J.POD® TECHNOLOGY EXPANDS EVOTEC’S CAPABILITIES INTO FLEXIBLE COMMERCIAL BIOLOGICS MANUFACTURING
- CONFIRMS EVOTEC’S ROLE AS LEADING EXTERNAL INNOVATOR FOR THE INTEGRATED OUTSOURCING OF DRUG DISCOVERY AND DEVELOPMENT
- ADDS CLINICAL DEVELOPMENT AND COMMERCIAL SUPPLY FOR BOTH NICHE AND LARGER QUANTITIES OF DRUG SUBSTANCE
- EVOTEC’S PARTNERS WILL BENEFIT FROM FLEXIBLE, HIGH QUALITY MANUFACTURING TO DE-RISK DRUG DISCOVERY AND DEVELOPMENT
Hamburg, Germany, 14 January 2020:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that the wholly-owned Seattle-based company Just – Evotec Biologics initiated the construction of a late-stage clinical and commercial manufacturing facility for biologics in Redmond, Washington.
The innovative cGMP biomanufacturing facility employs Just – Evotec Biologics’ J.POD® technology using small, intensified bioprocessing operations housed inside autonomous cleanrooms. The design of the physical plant and the processes used for manufacture are fully optimised for high efficiency and flexibility; reducing the plant footprint, environmental impact and the overall time of construction and cost involved with biologics manufacturing. Dedicated quality control and process development laboratories for both clinical and commercial products are being built into the facility.
With the site, Just – Evotec Biologics will be able to supply small and large quantities of high quality clinical or commercial grade biologics to meet the needs of its customers and partners. Fast and efficient change-over times will provide partners with the flexibility and security to produce portfolios of biologics.
Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: “We are delighted to initiate the construction of the first-ever J.POD® facility in North America shortly after the acquisition of Just – Evotec Biologics. The space-saving and cost efficient modular setup will make J.POD® the technology of choice for Pharma and biotech customers who need both high-yielding and flexibly scalable cGMP production facilities for their biologics. J.POD® is also ready for the future of personalised medicine which will require production of smaller batches of specialised biologics.”
J.POD® (manufacturing and plant design) is an integral part of the 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®.
Dr James Thomas, EVP Global Head Biotherapeutics, President U.S. Operations, commented: “We are excited about the opportunity to expand our capabilities and apply the J.POD® approach to later stage clinical development and commercial supply of biologics. This is foundational to accelerate drug development and to expand biotherapeutic access to a greater patient population. The flexible J.POD® facility will be capable of efficiently manufacturing a few kilograms to metric tons of drug substance. Instead of scaling-up capacity all at once, we will be scaling-out capacity as needed. This approach alleviates risk to both capital and operations because the same scale of operation will be used for both clinical and commercial manufacturing.”
Just – Evotec Biologics’ existing Seattle facility, which includes development labs and an early clinical phase manufacturing plant, will continue to operate as an integral part of Just – Evotec Biologics’ J.DESIGN capabilities.
Construction on the greenfield site, located in Redmond Ridge Business Park, was recently initiated and the new facility is expected to be completed by late 2020 and operational in the first quarter of 2021 – approximately 19 months from breaking ground to full operations. The 130,000 square foot facility will contain manufacturing pods for implementing intensified fed-batch or continuous processing up to 1,000 L scale, with the capability of manufacturing metric tons of drug substance. Also included are supporting quality labs, a warehouse, process development labs and collaborative office and meeting spaces for approximately 200 employees at full capacity.