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AmplifyBio has expanded its CRO and drug manufacturing leading portfolio with the addition of cell therapy and plasmid manufacturing capabilities aiming to develop an environment that de-risks the commercialization of next-generation therapeutics.
AmplifyBio will leverage decades of experience in cell therapy, gene editing and immune-focused products like engineered T cell receptor therapies to provide end-to-end development partnership for clients without delays and significantly reduces costs and timelines.
AmplifyBio is a budding hub for the commercialization partner and drug development for advanced therapies. Its portfolio provides safety testing and manufacturing support for end-to-end development partnerships with its state-of-the-art facility located in West Jefferson, Ohio and South San Francisco, California.
“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,” explained J. Kelly Ganjei, CEO of AmplifyBio.
J. Kelly Ganjei continued:
“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.”
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Clients will have the option to lease GMP space using ‘hoteling’ model of labs and GMP suites, send thought leadership on-site and make use of AmplifyBio’s growing team of subject matter experts, or outsource development and manufacturing completely. They will work collaboratively to develop a size and stage-appropriate commercialization plan, including scalable and automated manufacturing.
J. Kelly Ganjei concluded with the next steps for AmplifyBio:
“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.”
AmplifyBio’s Ohio site provides industry-leading dynamic safety needs of advanced therapy development such as preclinical toxicology, safety, and pharmacology testing in an agile environment with high-level analytics capabilities.
Source: AmplifyBio Press Release
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