Developed upstream processes for biotherapeutic production and transfer processes for early clinical manufacturing sites. Using a metabolism-targeted approach for media development, increased the volumetric antibody productivity of a fed-batch process by 2-fold.  Increased productivity and altered the antibody product glycosylation pathway to meet biological activity and circulatory half-life targets.  Selected by management to pilot an accelerated approach for the supply of reagent for toxicology and early clinical material using a platform high cell density perfusion system.

Primary responsibility is the rapid isolation of CHO cell lines producing high levels of recombinant proteins.  Developed animal source-free CHO media for high cell density, fed-batch culture by the systematic replacement of all animal source components. Developed enhanced basal formulations by step-fortification of amino acids and vitamins, and ultimately blending basal formulations to maximize protein expression. Implemented a small scale shake flask production model to predict the effect of process and media formulation changes on full scale bioreactors. Developed an improvement on the capacity of this model, by miniaturization, to increase the throughput of cell lines and media formulations evaluated from 25 to 500 cultures per incubator chamber.  Developed and implemented a commercial cell banking program. Also, wrote the supporting documentation describing, in detail, the preparation and qualification of the cell banks.

 Developed animal source-free media for the production of recombinant proteins in mammalian cells.  Developed a commercial master cell banking program. Developed methods for the rapid isolation of high producing and genetically stable recombinant CHO cell lines. Developed the genetic stability and product quality program for cell substrates.  To support the small molecule program, developed an in vitro cell system that mimics the intestinal mucosa to measure drug absorption via the principal drug transport mechanisms. This assay, with a three-day incubation period, is an improvement over the conventional 21-day incubation period, saving time and money.

Supervised the production of recombinant vaccines from mammalian cell culture in large scale continuous stirred tank reactors (CSTR). Responsibilities included coordinating the expansion of cells, construction of culture vessels, CSTR operations management, and assuring the availability of large amounts of perishable raw materials traced accurately in compliance with GMP.

Responsibilities included the development of low protein, serum-free media for the activation of lymphokine activated killer (LAK) cells. Prepared standard operating procedures for the isolation, activation, and short-term cytotoxicity assay for the LAK project.

Responsibilities included conducting experiments using fresh human tumor cells for chemosensitivity testing. Performed a stem cell clonogenic assay in semi-solid agar using nucleic acid precursor incorporation to measure drug effect. Responsible for cryopreservation and recovery of human tumor cells and established cell lines.

Successfully completed a project involving the culturing of bacteria; the isolation of bacteriaphage; viral protein purification; production of antisera; and the isolation of monoclonal antibodies.