Eileen Choi, Ph.D.

Eileen comes to Dark Horse Consulting with over two decades of experience in the biotech industry, bringing expertise in process and analytical development, process optimization, tech transfer, comparability, validation, and CMC strategy. She is well-versed in numerous methods to support the quality control of biologically derived products. At BioTechLogic, Eileen has supported multiple clients with a broad range of products across all stages of development. As a senior consultant for technical operations, she helped her clients with CMC strategy, including gap analysis for various stages of the product, risk assessment, and roadmap to IND and BLA. She also authored or reviewed Module 3 CTD sections and supported her clients with FDA interactions for various regulatory filings.

Eileen recently served as head of a CMC Task Force of over 60 people focused on obtaining BLA approval of a plasma-derived product for an established company in Korea. Under Eileen’s leadership, the product received FDA approval at the end of 2023, and she is now intimately involved with the continued process verification program.

Before joining BioTechLogic, Eileen served as Senior Director of Technical Operations (Process and Analytical Development) at ADMA, a biopharmaceutical company developing plasma-derived products for the treatment of patients with primary immunodeficiency (PI). Eileen spearheaded the process optimization project to resolve product aggregate issues and improve product quality for a commercial product under a Warning Letter. Eileen’s team optimized the DS manufacturing process and improved the product quality at every unit operation throughout the manufacturing process. Eileen authored the analytical comparability study protocol and reports for this optimization and led the cross-functional team in conducting the study. Her team then delivered data packages to support the complete response items and re-submission of the BLA, ultimately obtaining the approval from the FDA in April 2019.

Eileen’s early career was spent in both analytical and process development departments at biologics companies, including Biotest (now known as Grifols) and Goodwin Biotechnology (CDMO). At Biotest, she served as the Director of Process Development and was primarily responsible for supporting the manufacturing of plasma-derived commercial products, optimizing unit operations (plasma thawing, fractionation with centrifugation or filter press, solvent-detergent viral inactivation, chromatography, UF/DF, nanofiltration, and sterile filtration) and transferring the process from PD to production. She also conducted investigations for any process or analytical related deviations. Prior to this, Eileen served as the Senior Manager of Analytical Development at Biotest and was responsible for transferring and validating DS in-process tests, release tests, and characterization methods for several monoclonal antibody products at various stages.

As the Manager for Process and Analytical Development at Goodwin, Eileen was responsible for specific ELISA development for various mAbs (IgG and IgM), SEC-HPLC, SDS-PAGE, enzymatic assays, protein quantitation methods, and Western Blots. Eileen was also responsible for process development, including protein A, ion exchange, hydrophobic chromatography, low-pH viral inactivation, UF/DF, ion exchange filters, nanofiltration, and formulation. At Goodwin, Eileen also led viral clearance studies by establishing the scaled-down model unit operations, producing the in-process materials in support of the studies, and overseeing the contract organizations on behalf of the clients.