Allyson Davidson - Dark Horse Consulting

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years of experience

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years at DHC

Allyson

's Service Domains

CMC

Business Analytics

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 more than a decade. In addition, she has led teams and projects in process development, scale-up, validation, and technology transfer of cell therapies and clinical diagnostics throughout her career.

With DHC clients, Allyson has focused in particular on quantitative modeling needs, from build vs. buy to COGs analysis to facility mapping. In 2019, Allyson identified and began to address a significant need for a quantitative platform that could reduce risk by future-proofing CGT manufacturing facilities and COGs. She programmed such a platform from the ground up to support client planning needs, and over the course of the next four years, participated in expanding that program into the Pegasi quant modeling offering DHC has today.

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.

Before joining DHC, Allyson was a process engineer at Advanced Cell Diagnostics, 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.