The company said that the facility supports several recently announced partnerships, including one with Roche and Genentech, a wholly-owned member of the Roche Group, to develop and commercialise a sustained drug delivery formulation of Lucentis (ranibizumab injection), and other formulations for the treatment of ophthalmic diseases.
The facility is designed to support multiple clinical and commercial products and includes 16,000sqft of clean room production space. Each of the four clean room suites has independent air handling systems, enabling SurModics to accommodate multiple drug compounds in the same facility.
Support utilities and equipment include a 6,000 gallon water-for-injection system, vial washer, autoclave and depyrogenation oven. The facility is also equipped with the latest half-suit isolators for aseptic manufacturing processes, which are typically required to handle therapeutic proteins.
Additionally, support infrastructure includes a 5,300sqft quality control laboratory and a 2,400sqft microbiology laboratory, which will be used to monitor the facility and to test and release products for clinical and commercial use. The total build out was approximately 90,000sqft and also includes a 4,600sqft engineering lab, which will be used to scale up and develop additional processes.
Reportedly, the facility will be used to manufacture pharmaceutical and drug coated device products for both clinical and commercial products, throughout the SurModics organisation. It was constructed to handle the dosage forms, including microparticles, nanoparticles, liposomes, and implants, needed for extended-release delivery of a range of drug classes, including small molecules, peptides, proteins, and antibodies.
Bruce Barclay, president and CEO of SurModics, said: “The creation of a world-class cGMP facility enhances our capabilities to service our current and future customers from feasibility to commercial sales, and is a critical element in realising our future growth goals. We continue to be focused on effectively executing our business plan and maintaining our vision of extending and improving the lives of patients through technology innovation.”