Erik Whiteley

Erik Whiteley, Ph.D.

PRINCIPAL

Veteran process development expert with deep expertise in late stage product processes and a wide diversity of experience, spanning cell therapy, gene therapy, and protein/antibody therapeutics.

About Erik

Erik is a leader in biologics process development with 20+ years of experience across a wide range of products. Throughout his career, Erik has advanced cell therapies, gene therapies, and protein/antibody therapeutics through late-stage processes, meeting output, optimization, and regulatory targets.

Erik’s most recent role was at Asterias Biotherapeutics, where he advanced from Director of Process Development to Executive Director of Product Development & Research. There, he led process development efforts to develop improved late-stage manufacturing processes for stem cell-derived products in the immuno- oncology (AST-VAC2) and neurology (AST-OPC1) spaces, increasing yields, scalability, and reproducibility of first-in-class novel processes. Erik used a Quality by Design-like approach to support the exceedingly constrained and dynamic landscape at the company. He generated process technology roadmaps to prioritize development strategy, and mitigate risks and gaps, and designed and led the implementation of a process monitoring plan to support development and optimization of new and existing processes. In addition, Erik was responsible for leading multidisciplinary teams to maintain expertise in cell therapy technologies and production, overseeing an international tech transfer of a complex cell therapy manufacturing process, and supporting regulatory filings related to clinical study initiation and product comparability.

Erik’s career started at Berlex Biosciences where he advanced from a Scientist of Cell Culture & Fermentation Development to Lab Head of Upstream Process Development. As a scientist, Erik was responsible for perfusion reactor optimization, development of novel adenovirus harvesting techniques, and equipment purchasing for cGMP manufacturing. He also helped lead technology transfer, regulatory filing, CMO evaluation, and upstream process characterization for a gene therapy virus product. As lab head, he gained responsibility for process scale-up of both a cytokine conjugate, and novel cell therapy, successfully increasing yield and production of both.

Erik has also held leadership roles in process development and process sciences at three additional prominent pharmaceutical companies: Boehringer-Ingelheim, Geron Corp., and Bayer. At these companies, he led upstream process development strategies of cell therapy products in Phase I to Phase III trials. In addition, he was responsible for preparing documentation and communicating details for regulatory compliance and technology transfer. Erik also used process modeling and statistical analysis to achieve and implement product purity and yield improvements. His breadth of experience across multiple companies and product types gives Erik a wide scope of process development knowledge to apply to the challenges faced by DHC’s clients.

SELECTED PATENTS

  • United States Provisional Patent Application No. 62/796,077, filed January 23, 2019. “Dorsally-derived Oligodendrocyte Progenitor Cells from Human Pluripotent Stem Cells”,  Onishi, K, Manley, N.C., Halberstadt, C.,  Whiteley E.M.
  • United States Provisional Patent Application No. 62/733,621, filed September 19, 2018.  “Methods for Differentiating Pluripotent Stem Cells in Dynamic Suspension Culture”, Nair, R., Kayser, S., Parikh, A.S., Whiteley E.M., Manley, N.C., Halberstadt, C.
  • US Patent 6,773,909: Concentration and Lysis of Adenovirus-Infected Cells in a Single Unit Operation, Inventors: Whiteley, E.M., Monica, T.J.
 
 

SELECTED PUBLICATIONS

  • Li Y., Gautam A., Yang J., Qiu L., Melkoumian Z., Weber J., Telukuntla L., Srivastava R., Whiteley E.M., Brandenberger R. “Differentiation of Oligodendrocyte Progenitor Cells from Human Embryonic Stem Cells on Vitronectin-Derived Synthetic Peptide Acrylate Surface.” Stem Cell Dev., 22(10), 1497–1505 (2013)
  • Monica, T. J., Montgomery, T., Ayala, J.L., Schoofs, G.M., Whiteley, E.M., Roth, G., Garbutt, J.J., Harvey, S., and Castillo, F.J. “Monitoring Adenovirus Infections with On-line and Off-line Methods.” Biotech. Prog.,16(5), 866‐871(2000)
  • LeDuc, P. R., Whiteley, E. M., and Betenbaugh, M. J. “Investigating the Secretory Pathway of the Baculovirus-Insect Cell System Using a Secretory Green Fluorescent Protein.” Biotech. Prog.,16(5), 716‐723 (2000)
  • Whiteley E. M. and Betenbaugh, M. J. “Protein Processing: Processing in the Endoplasmic Reticulum and the Golgi Network.” in Encyclopedia of Cell Technology (Spier, R.E., ed.) 1075‐1090, John Wiley & Sons, New York (2000).

 

PAST EXPERIENCE

Asterias Biotherapeutics
Executive Director of Product Development & Research
Senior Director of Process Development
Director of Process Development

Boehringer-Ingelheim
Associate Director of Cell Culture Technology, Process Sciences

Geron Corporation
Associate Director of Process Development, Process Sciences

Bayer Healthcare Pharmaceuticals
Principal Process Development Engineer

Berlex Biosciences
Lab Head, Upstream Process Development
Scientist, Biochemical Engineering
Scientist, Cell Culture & Fermentation Development

 

EDUCATION

The Johns Hopkins University
Ph.D. in Chemical Engineering

Pennsylvania State University
B.S. in Chemical Engineering, with Honors

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