Allyson Davidson

Allyson Davidson, Ph.D.

SENIOR CONSULTANT

Data-driven engineer and subject matter expert in cell cryopreservation, process optimization, scale-up, and technology transfer of cell therapies and clinical diagnostics.

About Allyson

Allyson joined Dark Horse Consulting in 2018 as a senior consultant, bringing expertise and leadership in cryopreservation, cell enrichment, process design, and technology transfer.  Allyson has been studying, inventing and perfecting cryopreservation techniques for nearly a decade. In addition, she has led several teams and projects in process development, scale-up, validation, and technology transfer of cell therapies and clinical diagnostics throughout her career.

Allyson is skilled in streamlining and optimizing process methods using Design of Experiments and statistical data analysis. Her expertise also includes the use of magnetic-activated cell sorting (MACS) for cell isolation and enrichment.

Allyson’s proficiency of cryopreservation techniques started in graduate school where she earned a Ph.D. in Chemical Engineering, achieving novel research on the optimization of cryoprotectant addition and removal procedures for vitrification of adherent mammalian cells. At Cellerant Therapeutics, she served as a scientist in both the process development, and animal analog manufacturing groups, gaining skills in process scale-up for cryopreservation and cell enrichment. Her work included the design, scale-up, and management of processes for isolation of hematopoietic stem cells using MACS technology and subsequent culture to produce myeloid progenitor cells, as well as GMP-like CD34+ equivalent cell enrichments at the AutoMACS and CliniMACS scale from NHP and mouse species source material.

More recently, at Advanced Cell Diagnostics, Allyson was a process engineer responsible for the technology transfer of the company’s first GMP product line from development to manufacturing. She generated SOPs, specifications, and trained operators on GMP processes, while managing the validation of the fill and finish process for a globally commercial product. Allyson was also involved in the resolution of NCP, CAPA, process changes, and risk assessment at the company.

 

EXAMPLES OF RECENT WORK

  • Built detailed cost of goods (COGS) model for client current and future state processes
  • Wrote major sections of CMC portion of IND filing for novel cell therapy product
  • Performed market survey to identify and evaluate unmet needs in cell therapy manufacturing device landscape
  • Project management of technology transfer activities to contract manufacturing organization
 
 

PAST EXPERIENCE

Advanced Cell Diagnostics
Process Engineer – Manufacturing Technical Services

StemCells Inc
Process Engineer – Process Development

Cellerant Therapeutics Inc
Scientist – Animal Analog Manufacturing
Scientist – Process Development

Life Technologies
R&D – Primary and Stem Cell Systems Division

 

EDUCATION

Oregon State University
Ph.D. and M.S. in Chemical Engineering

Vanderbilt University
B.E. in Biomedical Engineering