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Stephen Raillard, Didier G Benoit, Wayne To, Yuhua Hu, Stephen Charles, D. Victor Perlroth; Manufacturing of novel ultra-high molecular weight branched biopolymers for use with antibody based bioconjugate therapies. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5311. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
Development of an aqueous, optically clear biocompatible polymer platform that can pair with therapeutic antibodies to generate next generation therapies with enhanced durability and stability as compared to current agents.
We designed a multi-branched polymerization initiator and studied polymerizations with methacrylate-based phosphorylcholine containing monomers with the goal of producing very large (>2,000 monomers) water-soluble polymers with controlled molecular weight, polydispersity, composition, chain architecture, and site-specific functionality. The desired antibodies of choice can be attached to the biopolymer via a stable covalent linkage. Key success factors were the parallel optimization of initiator architecture, monomer features and the fine-tuning of controlled/living polymerization chemical process parameters.
A manufacturing process was developed and successfully applied in the production of a well characterized custom biopolymer under current good manufacturing practices on batch scales approaching 10 kilograms. This is sufficient manufacturing scale to support clinical development through early commercialization of Kodiak’s ophthalmic biologics pipeline.
A novel biopolymer platform was developed that features a high molecular weight phosphorylcholine based biopolymer that is manufactured with high-fidelity and allows for the development of well-characterized, optically clear antibody based bioconjugate therapies.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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