AmplifyBio, a preclinical contract research organization (CRO), intends 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.

In a statement, the company said that it has initiated additional partnership agreements that are designed to 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 said that it 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, the company announced that they are onboarding platforms to do that in the coming quarter.

The company’s South San Francisco site, branded A-DOC (Amplify – Discovery, Optimization, and Characterization), is 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.

“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.”

In addition, AmplifyBio plans to add a third site in New Albany, OH, that consists of 350,000 square-feet of multi-function lab spaces. There, AmplifyBio plans to 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.