On October 3, 2022 AmplifyBio, a contract research organization (CRO) focused on accelerating innovation across pharmaceutical modalities; reported the acquisition of select assets from PACT Pharma, Inc., a privately held biopharmaceutical company developing neoantigen-specific T cell receptor cell therapies (Press release, AmplifyBio, OCT 3, 2022, View Source [SID1234635613]). The deal will provide AmplifyBio with advanced characterization platforms, bioinformatics capabilities, and 40 drug development experts to enhance their cell and gene therapy service offerings. AmplifyBio will also acquire the South San Francisco advanced laboratory space.
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With the acquisition of these assets, AmplifyBio aims to provide an early, consistent characterization of a treatment’s purity, potency, and viability throughout the life cycle of therapeutic development. Unlike small molecules, there is no single, consistent process for cell and gene therapy companies to research, develop, and test their therapeutics. The gap that exists in characterization between the discovery phase and preclinical testing leads to material changes in a therapeutic during development, which can in turn create manufacturing inconsistencies and safety concerns during scale-up.
"Many biologics developers have adopted the phrase ‘the process is the product’ to describe how their therapeutic is differentiated based on a unique development process," said AmplifyBio Chief Executive Officer (CEO) and President J. Kelly Ganjei. "Rather than create our own, individual technique, AmplifyBio aims to replace that saying with a new one: ‘the product is the product. Our acquisition of these assets from PACT Pharma means that cell and gene therapies can now be differentiated based on safety and efficacy profiles and specific product characteristics, not development processes."
"This deal allows PACT to retain its core intellectual property and continue our mission of developing novel, neoantigen-targeted T-Cell Therapies," added Scott Garland, PACT Pharma’s CEO. "At the same time, we’re working with AmplifyBio to leverage our platforms to offer a unique combination of optimization, characterization, safety and efficacy services to a wider range of clients seeking to better understand the immunology of their adoptive cell therapies."
AmplifyBio was spun out in 2021 from Battelle, a not-for-profit organization that advances science and technology to have the greatest impact on our society and economy. Following today’s acquisition of the South San Francisco facility, 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 expects to add additional development platforms and partnerships to become a commercial accelerator delivering safe, effective, reproducible advanced therapies to patients.