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AmplifyBio offers comprehensive outsourced research and development (R&D) services tailored to the needs of biotech and pharmaceutical companies by providing end-to-end support from concept to commercial success. With expertise in product characterization, process scale-up, process development, optimization, assay development, and analytical services, AmplifyBio is a trusted partner in driving therapeutic innovation and advancing client pipelines.
AmplifyBio offers a comprehensive range of development and discovery services, with particular expertise in T cell therapy including TCR-T and CAR-T therapies, immunotherapy, plasmid design and development, protein engineering, mRNA therapeutics, and non-viral gene editing.
With a deep commitment to advancing therapeutic innovation, AmplifyBio offers not just a list of assay capabilities or R&D programs but rather, human experts with state-of-the-art platforms and real experience bringing novel drugs to the clinic. With our technology-integrated experience, we are poised to meet the complex needs of biotech and pharmaceutical companies.
Deep understanding of product functionality, efficacy and characteristics are the key to mitigating downstream development risks. Read more about AmplifyBio’s The Product is the Product™ promise.
AmplifyBio excels in developing next-generation T-cell therapies, utilizing cutting-edge techniques to engineer, modulate, orenhance T-cell function. Our services cover the entire development process, from initial research and development to optimization for manufacturing scale-up and internal tech transfer to our GMP manufacturing facility.
AmplifyBio is a leader in CAR-T therapy research and development, offering advanced solutions for the creation and optimization of CAR-T cells. Their expertise in CAR-T cell manufacturing and R&D services provides clients with the tools needed to develop effective personalized or off-the-shelf treatments.
As a trusted partner in T-cell receptor (TCR) R&D, AmplifyBio delivers comprehensive contract research services. Our team of experts focuses on TCR therapeutics development, T-cell receptor engineering, advanced TCR screening, and TCR bispecifics, ensuring that clients can confidently advance their projects with a team that has taken personalized TCR therapeutics to the clinic. Clients can also benefit from AmplifyBio’s established IND platform, which is available for client use and speeds up time to the clinic.
AmplifyBio is at the forefront of TCR safety assessment, providing comprehensive evaluations of specificity, alloreactivity, off-target effects, and function. Our rigorous testing helps ensure that TCR therapies are safe, paving the way for successful clinical outcomes. Beyond in vitro safety assessment at the AmpifyBio ADOC facility, clients can leverage in vivo safety capabilities available through the AmplifyBio preclinical ASET facility.
We know that time to the clinic is critical for companies looking to bring innovative cell therapies to patients. Because of this, AmplifyBio has available IND-read documentation, reports, and underlying data to support client IND filings. Using our NVGE platform enables clients to simply plug our genomic safety and CMC data into their IND to simplify the filing process.
The AmplifyBio team brings to the table a broad and varied experience to the development of cell therapies. We have expertise in cell biology, immunology, bioinformatics, and cell engineering related to developing and characterizing cell therapies to the table. We apply this experience across business units to offer cell therapy R&D services, including everything from preclinical research to clinical-grade production. Our contract research organization (CRO) services cover cell therapy development, process optimization, and characterization, ensuring clients can access the highest quality solutions.
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AmplifyBio excels in the design, cloning, and production of RUO plasmids to deliver customized solutions that meet the specific needs of client projects. Our RUO plasmid platform is compatible with many types of plasmids, including transfer and helper plasmids used to generate viral particles, homologous repair plasmids used to edit cells, input plasmids for mRNA production, or simple plasmids used to deliver transgenes to cells transiently. Our plasmids meet the high-quality standards for advanced therapy work with a rapid turnaround time. RUO plasmids can be seamlessly transferred to our AMEC facility for large-scale GMP manufacturing.
AmplifyBio is a leader in producing RUO mRNA, providing comprehensive services that include mRNA design, synthesis, encapsulation, and quality control. Our expertise in mRNA design ensures that clients receive high-fidelity mRNA constructs optimized for their specific needs. AmplifyBio also offers lipid nanoparticle (LNP) encapsulation for mRNA, facilitating efficient delivery in experimental settings. With stringent quality control and specification adherence, AmplifyBio’s RUO mRNA services empower researchers to explore novel mRNA-based therapies and technologies confidently. mRNA can be scaled up for clinical and commercial use at AMEC, AmplifyBio’s GMP manufacturing facility.
AmplifyBio offers state-of-the-art non-viral gene editing services, including immune cell editing using nucleases such as Cas9, T cell editing, CAR-T insertion, and cell line editing. With expertise in base editing and prime editing, they provide innovative solutions for developing next-generation gene therapies. The non-viral gene editing services available at AmplifyBio have been validated in human trials and 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.
AmplifyBio provides advanced protein engineering services, to produce custom proteins tailored to the unique requirements of each project. Their team of experts excels in the engineering of antibodies, bispecifics, and other therapeutic proteins, ensuring high levels of specificity, stability, and functionality AmplifyBio also offers extensive expertise in the development of protein-based assays, providing clients with reliable and sensitive methods for analyzing protein interactions, function, and stability. Their services include designing and validating custom assays for biomarker detection, therapeutic efficacy testing, and pharmacokinetics.
AmplifyBio supports vaccine development, including mRNA vaccines, neoantigen prediction, and immunogenicity assays. Their capabilities in molecular assays, PCR, cell biology assays, and bioinformatics provide comprehensive analytical support, enabling clients to develop effective cancer vaccines and therapies.
AmplifyBio provides comprehensive analytical and characterization services to support the development and testing of cell therapies. Their expertise in cell therapy potency assays, process development, and characterization in cell therapy development ensures that clients can confidently move their products through the R&D pipeline.
With the expertise to design the right study for every model and flexibility for data-driven implementation, AmplifyBio is your partner to trust for Preclinical Contract Research Organization Services. Talk with us and discover how we can support your study and compliance requirements.
