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AmplifyBio offers a validated TCR discovery and development engine that enables clients to enter the TCR-T or TCR-bispecific space without building costly internal capabilities. Coupled with preclinical animal models, gene editing, manufacturing, and immune monitoring capabilities, clients can partner with AmplifyBio throughout the discovery, development, and commercialization of TCR-T therapies.
AmplifyBio has a validated TCR discovery and characterization platform that has generated TCRs that have been in the clinic in humans. The workflow includes services for target ID, characterization, safety assessments, and a non-viral editing approach for manufacturing cell products. This workflow provides clients looking to enter the TCR-T cell therapy field with an integrated process to move from target identification to commercialized products. A robust menu of assays and technologies can be utilized to understand or further develop cell therapy products.
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Validated Workflow |
No cost to build or validate a workflow, can begin generating therapeutic TCRs immediately, extensive know-how on how to find the best TCRs
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High Sensitivity TCR Identification |
Screening platform can identify TCRs at a frequency of 1 in 300,000 by scanning millions of T cells using patented technologies
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Preclinical Testing Assay Suite
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Suites of preclinical in vitro assays worked out to select best TCRs and assess functionality, specificity, off-target effects, mechanism-of-action
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IND Support
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Generation of reports to support IND filing, CMC documentation support
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Seamless Transition to Manufacturing
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Transition to manufacturing using existing non-viral gene editing manufacturing process and product release testing
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The non-viral gene editing services available at AmplifyBio can be used to make efficient modifications, including simultaneous knock-in and knock-out of genes of interest in client cells, with exceptional accuracy and proven clinical safety, for discovery, optimization, and production of transformative therapeutics. The platform is extensible to more complex cell editing, including tunable and inducible gene expression, knockdown through shRNA, and edits to allow T cells to be local delivery agents for bioactive molecules and can accomplish dual knock-in at distinct locations in one step.
Manufacturing of advanced therapies is not just about finding capacity. It’s about finding the right capacity. At AmplifyBio, you will find not just a CDMO, but a technology-integrated partnership with expertise in manufacturing cell therapies, gene therapies, mRNA, and plasmids. Manufacturing services are available today in flexible staffing models that range from traditional outsourcing partnerships, to ‘hoteling,” and for any batch size, making AmplifyBio the most agile, innovative advanced therapy manufacturing partner in the market.
Comprehensive service programs for the development of Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial. Offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing available in an integrated, innovation-rich environment that goes beyond the value proposition offered by traditional CDMO and PDMO contract models.
