SurModics has opened a 90,000 square foot manufacturing and development facility in Birmingham, AL. The firm will consolidate its operations in Alabama into this new site, which will be used to manufacture pharmaceutical and drug-coated device products for clinical and commercial use.
SurModics picked up the facility in Alabama in April 2008 for $30 million. It has since been constructed to handle various dosage forms like microparticles, nanoparticles, liposomes, and implants needed for extended-release delivery of a range of drug classes including small molecules, peptides, proteins, and antibodies.
The facility includes 16,000 square feet of cleanroom production space. Each of the four cleanroom 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 state-of-the-art half-suit isolators for aseptic manufacturing processes, which are typically required to handle therapeutic proteins.
Support infrastructure includes a 5,300 square foot quality-control laboratory and a 2,400 square foot 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 90,000 square feet and also includes a 4,600 square foot engineering lab, which will be used to scale up and develop additional processes.
“Opening this facility is a tremendous step in our multiyear vision to commercialize important parenteral and coated drug-delivery products,” says Arthur J. Tipton, Ph.D., vp and president of SurModics Pharmaceuticals. “With several programs in clinical development, we believe the capability to manufacture commercial products represents a significant competitive advantage and will greatly assist our clients in bringing their products to market. Our investment in this facility reduces risk for customer programs, can shorten time to market, and maximizes the opportunity for programs to reach the royalty-generating phase of our business model.”
The re-built site will support the company’s partnerships including one with Roche and Genentech to develop and commercialize a sustained drug-delivery formulation of Lucentis®, currently marketed for age-related macular degeneration. The deal also includes the development of other formulations of the drug for the treatment of various ophthalmic diseases.