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AmplifyBio Emerges as a Leader in Cell Therapy Characterization, Filling a Gap in Pre-Clinical Development

AmplifyBio builds on the T-cell immunology expertise of its South San Francisco-based team, adding technology platforms and capabilities in single-cell analysis and product assessment in the context of a tumor microenvironment.

PRESS RELEASE  MAR 16, 2023 07:00 EDT

SAN FRANCISCO, March 16, 2023 ( – AmplifyBio, a preclinical CRO provider, spun out from the Battelle corporation in mid-2021, signaled the intention to build on discovery and characterization capabilities with the purchase of assets, including a site and a team of TCR-based drug development experts from PACT Pharma late last year. Since then, AmplifyBio has initiated additional partnership agreements that will enhance their ability to perform single-cell genotype and phenotype assessment of CAR-Ts and other cell-based therapies, providing more granularity to product characterization, especially in context with drug potency. AmplifyBio also recognizes the importance of refining the study of drug products in tumor microenvironments as the cell-based drug development community develops more therapies focused on attacking solid tumors. To that end, they are onboarding platforms to do that in the coming quarter. 

AmplifyBio’s South San Francisco site, branded A-DOC (Amplify – Discovery, Optimization, and Characterization), is already partnering with several clients developing cell therapies to design and execute functional characterization assays, identify therapeutic TCRs, provide services in protein and cell line engineering, and carry out vector/payload design and optimization. AmplifyBio’s mission is to provide a versatile platform for discovery and commercialization to all advanced therapy clients. Due to its background and recent investments, AmplifyBio has become a sought-after partner for clients specializing in developing modified cell therapies like CAR-T, TCR-T, and eTCRs. By partnering with AmplifyBio’s capabilities and expertise, these clients can not only extend their financial runway and optimize their investment spending on research and development but can leverage the expertise of a seasoned team across a variety of advanced therapies.

“Cell and gene therapy developers are responding to the significant number of disruptions and delays we are seeing in product scale-up for CMC [chemistry, manufacturing, and controls] related issues,” said J. Kelly Ganjei, CEO of AmplifyBio. “Those CMC issues are incredibly costly, often devastating to a development program, and largely preventable. We are seeing a growing number of eTCR, TCR-T and CAR-T companies choose us to mitigate the financial and product development risks of creating these capabilities from scratch. There’s no substitute for experience bringing these drugs to the clinic, and there are just not that many people who have done it.”

AmplifyBio plans to add a third site in New Albany, Ohio, that consists of 350,000 square feet of multi-function lab spaces. There, AmplifyBio will build on its advanced therapy services by adding capabilities for complex genotypic and phenotypic characterization analysis for late-stage development. The company aims to become the commercial accelerator of choice for delivering safe, effective, reproducible advanced therapies to patients. 

About AmplifyBio

AmplifyBio is a leading preclinical CRO focused on toxicology, safety and pharmacology testing, as well as advance therapeutics for the betterment of human health. Spun out of Battelle in May of 2021, AmplifyBio’s mission is to continue to provide exceptional preclinical CRO study services in an agile environment better suited to commercial goals and expand analytic capabilities to serve the dynamic needs of advanced therapy development. Clients of AmplifyBio enjoy the peace of mind that comes from decades of experience in GLP and non-GLP study design and execution, combined with rapid investment in technology, expertise, and infrastructure that together provide the critical components of a reliable, agile partnership.

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