Pharmaceutical and drug-coated device products for clinical and commercial use
SurModics Pharmaceuticals launched a new cGMP facility for manufacturing and development on 21 January 2010. Located at 750 Lakeshore Parkway in Birmingham, Alabama, less than half a mile away from the company’s headquarters, the facility develops pharmaceutical and drug-coated device products for clinical and commercial use.
The facility was expected to consolidate all SurModics Birmingham operations at one location. However, in December 2010 SurModics announced its intention to divest its pharmaceutical division, including the plant, to focus on its medical device platform, I-vation delivery system and diagnostics divisions. The decision followed an unexpected loss posted by the company in 2009 and the sudden resignation of CEO Bruce Barclay in June 2010.
Formerly known as Brookwood Pharmaceuticals, SurModics Pharmaceuticals is a leading provider of drug delivery, biomaterials and clinical trial manufacturing.
It develops a broad range of delivery technologies, primarily focusing on long-acting parenterals including injectable microparticles and injectable solid implants to deliver small molecules, peptides, proteins and nucleic acids.
The company has facilities for conducting Phase I and Phase III studies, and launching commercial products of small and medium size.
The facility has increased SurModics’ production capacity and provides the company with commercial-scale manufacturing capabilities. It supports SurModics’ alliance with Roche and Genentech to produce and market a sustained drug delivery formulation of Lucentis (ranibizumab injection) and other formulations developed for the treatment of ophthalmic diseases. The alliance was announced in October 2009.
In May 2010, the facility received the Det Norske Veritas (DNV) certification. The certification is awarded to facilities that comply with Quality Management System Standards ISO 9001:2008 and ISO 13485:2003.
Birmingham cGMP facility
The facility is situated on a 90,000ft² site. Designed to support a number of clinical and commercial products, the facility includes a 16,000ft² clean room production space divided into four suites.
Each suite is equipped with an independent air-handling system that allows multiple drug compounds to be accommodated in the facility simultaneously. Two suites are devoted to processing, including microencapsulation, extrusion, liposomes and nanoparticles. The remaining two suites are employed for solution preparation.
The facility also has a 5,300ft² quality control laboratory and a 2,400ft² microbiology laboratory for monitoring the facility and testing and releasing of clinical and commercial products. To oversee scaling up and the development of more processes, a 4,600ft² engineering laboratory is also housed inside the facility. The cGMP facility is fully equipped to develop products that require terminal sterilisation.
Half-suit isolators that support aseptic manufacturing, primarily of therapeutic proteins, are installed in the facility. Support equipment including a water-for injection system with a 6,000gal capacity, an autoclave and depyrogenation oven and a vial washer are also installed in the facility.
SurModics’ production capacity
The facility is designed to produce pharmaceutical and drug-coated device products for clinical and commercial products across SurModics. Microparticles, nanoparticles, liposomes, implants and other dosage forms required for sustained-release delivery of several drug classes including small molecules, peptides, proteins and antibodies are also developed in the facility. The highest standard of aseptic manufacturing will be adopted in the facility.
The facility is used by Nupathe, a neuroscience speciality pharmaceutical company for the development and commercial supply of clinical material. Under a licence agreement made on 2 November 2009, Nupathe agreed to use SurModics’ drug delivery technology and manufacturing expertise to develop a long-acting treatment for Parkinson’s disease.
The facility uses isolation technology for drug and medical devices. Using the technology, 100kg microparticle batches, for instance, are enclosed in a containment device. The technology places a barrier between the process and its operators, providing protection to the process and materials.
cGMP facility construction
Construction of the facility began in April 2008 after a new building with office and warehouse space was acquired by SurModics.
The 286,000ft² building situated on a 42-acre site was well suited to accommodate the requirements for the production of large-scale pharmaceutical products. In 21 months SurModics made major infrastructure investments at the building and converted it into a cGMP-compliant facility for parenteral and drug-coated device products.