SurModics has opened a 90,000 sq ft cGMP manufacturing and development facility in Birmingham, Alabama, US to support its partnerships and shorten time to market.
Roche and Genentech were among the companies to ink deals with SurModics last year. Boosted by these deals SurModics posted a 111 per cent increase in operating income in the 2009 financial year and the expansion is designed to support this growth.
Notably, the expansion gives SurModics commercial-scale manufacturing capacity. The company believes this will help clients shorten time to market. Also, it maximises the opportunity for programmes to reach the royalty-generating phase of SurModics’ business model.
Work began on the site when SurModics acquired a new building in April 2008. Since then the company has made a significant infrastructure investment to build a current good manufacturing practice (cGMP) compliant facility for parenteral and drug coated device products.
Housed at the site is 16,000 sq ft of cleanroom production space. This is split into four suites, each with independent air handling systems, to allow SurModics’ to work on multiple drug compounds simultaneously.
Half-suit isolators have been installed for aseptic manufacturing, typically of therapeutic proteins, as have a 6,000 gallon water-for-injection system, vial washer, autoclave and depyrogenation oven.
To support these operations SurModics has built a 5,300 sq ft quality control laboratory and a 2,400 sq ft microbiology testing room. These laboratories will monitor the facility and test and release products for clinical and commercial use.
Also housed at the site is a 4,600 sq ft engineering laboratory for scale up and development of additional processes. Housing all these functions at one location consolidates SurModics’ Birmingham operations.
Arthur Tipton, president of SurModics Pharmaceuticals, said that many current and prospective clients have expressed a strong interest in the facility and expanded suite of services now offered.