GLP and GMP Production
Morphotek leverages its internal scientific expertise and regulatory know-how to develop and scale-up manufacturing processes to produce high-grade recombinant proteins and antibodies to test in experimental systems and, ultimately, to support clinical studies. The company operates out of its R&D facilities and a 60,000 sq. ft. cGMP pilot plant to support the manufacturing of its advanced therapeutic candidates. The Morphotek pilot plant facility is designed with state-of-the-art, highly automated, scalable bioreactors, using both fixed and disposable technologies with associated downstream purification capability, which enable the rapid scale-up and optimization of processes from lab to 1000L bioreactor scale. The facility is designed to support multiple products concurrently using either cell culture or microbial systems. In addition to cGMP suites, the facility contains laboratories for technology transfer, release testing and stability studies. The company is leveraging the use of its manufacturing capabilities to support its preclinical and clinical pipeline programs, as well as to assist strategic partners in need of GMP manufacturing support.