AmplifyBio is adding manufacturing services, starting with cell therapy and plasmids, to its growing capabilities to support the safe development of advanced therapies.
WEST JEFFERSON, Ohio, May 15, 2023 (Newswire.com) – AmplifyBio, an emerging hub for the commercialization of advanced therapies, has announced the addition of cell therapy and plasmid manufacturing capabilities to its leading portfolio of preclinical CRO and drug characterization services. The GMP cell therapy and plasmid manufacturing labs, available in South San Francisco, are the latest step in AmplifyBio’s broader strategy to build a development environment that de-risks the commercialization of next-generation therapeutics.
AmplifyBio recently acquired from PACT Pharma, Inc, a privately held biopharmaceutical company developing neoantigen-specific T cell receptor cell therapies, certain capabilities including advanced characterization platforms, bioinformatics capabilities, and a staff of drug development experts with decades of experience in cell therapy, gene editing and immune-focused products like engineered TCR therapies.
With today’s announcement, AmplifyBio is adding a variety of manufacturing services to its development sandbox. Clients will have the option to lease GMP space in a purely “hoteling” model, send thought leadership on-site and make use of AmplifyBio’s growing team of subject matter experts, or outsource development and manufacturing completely. AmplifyBio will work collaboratively to develop a size and stage-appropriate commercialization plan, including scalable and automated manufacturing. In all three collaborative service models, clients will benefit from AmplifyBio’s quality management, characterization, and optimization capabilities and have the option to add integrated preclinical safety or optimization services to their projects.
“We are excited to be able to add cell therapy, gene editing manufacturing and development capabilities in a number of flexible configurations to our portfolio of services,” said J. Kelly Ganjei, CEO of AmplifyBio. “This is an important milestone for us as we build a product-focused commercialization partner for advanced therapies, but it’s only the beginning. Over the coming months, we will continue to add platforms for manufacturing additional modalities across our sites. Our next addition will be to add mRNA manufacturing, and we will continue to add characterization platforms and partnerships that ensure the product stays the product, from concept to the clinic.”
Cell therapies have the potential to revolutionize the treatment of various diseases and conditions, including cancer, autoimmune disorders, and genetic diseases, but their manufacture is fraught with unanticipated chemistry, manufacturing, and controls (CMC) delays, often resulting from a failure to fully characterize the drug and its function. AmplifyBio is leveraging decades of experience to provide clients with a development sandbox that avoids those delays.
AmplifyBio is a drug development and commercialization partner for advanced therapies with sites in West Jefferson, Ohio, and South San Francisco, California. The Ohio site provides industry-leading preclinical toxicology, safety, and pharmacology testing in an agile environment with high-level analytics capabilities to serve the dynamic safety needs of advanced therapy development. AmplifyBio’s California location is dedicated to expert drug discovery, optimization, and characterization services. AmplifyBio clients can harness decades of experience in drug development, safety testing, and manufacturing support services for an end-to-end development partnership that significantly reduces costs and timelines.