ANTIBODY AND PROTEIN ENGINEERING TECHNOLOGIES
Morphogenics is a broad-based proprietary platform technology that regulates the ability of a host organism to repair mutations that occur during DNA replication. All proliferating cells duplicate their genetic material prior to dividing into two siblings (sibs). During the replication process, thousands of mutations occur that are corrected prior to cell division by DNA repair mechanisms. One of the most robust repair mechanisms is the highly conserved process called mismatch repair (MMR), which proofreads newly replicated DNA for mutations. The process is similar to a computer spell check function. Once the MMR process is completed and mutations in the new genome have been corrected, the cell divides into two genetically identical sibs. Cells with dysfunctional MMR accumulate mutations throughout their genomes, leading to mutant gene(s) that yield sibs with traits different from that of the parent.
The selective regulation of the MMR function via morphogenics results in an unbiased, undirected and accelerated rate of genetic evolution within a living host organism. This unique feature makes morphogenics a highly desirable technology for creating molecules with biologically important and commercially attractive traits.
Morphotek has leveraged morphogenics through the following applications:
- Human MORPHODOMA® technology employs an ex vivo immunization process in combination with morphogenics to generate fully human antibodies targeted against disease-associated antigens. The resultant antibodies are fully human with high-affinity and target specificity.
- Libradoma™ technology generates libraries of hybridomas that can be rapidly screened to identify fully human monoclonal antibodies to known antigens and novel targets for the diagnosis and treatment of diseases in humans. This platform is being widely pursued internally to feed our future therapeutic antibody pipeline.
Morphogenics technology has been validated though research collaborations with premier corporate partners including Abgenix, Amgen, Centocor, Novo Nordisk, PDL, GSK, Tanox, and Wyeth, as well as though its application to internal development candidates.
Manufacturing Technologies – 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 for supporting 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, scaleable bioreactors, using both fixed and disposable technologies with associated downstream purification capability, that 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 partnerships in need of GMP manufacturing support.
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