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Advanced Modalities: mRNA, Cell and Gene Therapy Manufacturing Services

Partnering with AmplifyBio for your manufacturing needs for cell therapy, gene therapy, mRNA, plasmid, or other complex supply chain components is quite different than a typical CDMO experience. From concept to commercial, AmplifyBio ensures that R&D is conducted with CMC in mind and that process development through commercial cell and gene manufacturing is done with a scalability and cost mindset. 

mRNA Design, Safety, and Manufacture

With an established record for safety, potency, and effectiveness, mRNA-based therapeutics are a fast-growing area of interest for application across many disease areas. AmplifyBio has built for-purpose in vivo and in vitro safety assessment capabilities for mRNA/LNPs and manufacturing suites that can be customized for the early stage through GMP manufacture.  

To better meet the needs of this development area, AmplifyBio is partnering with RNAV8 Bio to ensure clients start with well-designed, optimized, stable mRNA.

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A Facility Built for Advanced Therapy Manufacturing

Advanced therapies experience 400% more chemistry, manufacturing, and control (CMC) related developmental disruptions when compared to other large molecule biologics such as mAbs. AmplifyBio is addressing that challenge by building manufacturing centers where robust characterization is integrated into a manufacturing strategy, ensuring that not only is process development critical but that also, the PRODUCT is the PRODUCT.

What do we mean by that? Process and analytic development is critical when manufacturing cell and gene therapies, but at AmplifyBio you will also identify the product characteristics that ensure the product at discovery, is the same one being scaled up. 

New Albany, Ohio

Choose the support model that best fits your needs

Hoteling Model

Customizable development labs and GMP suites to enable advanced therapy development and manufacturing through a lease of space. We provide a state-of-the-art facility, QMS and QC, and supply chain management. You stay in control of your process and in control of your timelines.

Hybrid SME+ Model

In this model, clients can send their thought leaders on-site to participate in setting up, personnel training, and executing development and manufacturing processes while relying on AmplifyBio’s scientific and support staff to create the perfect team for the task at hand. 

Full-Service Partner Model

In this model, clients work hand–in–hand with AmplifyBio to develop a robust plan and then trust us with all aspects of the development and manufacturing plan. From initial concept to final product, this model allows clients to focus on other critical aspects of their business while leveraging decades of experience. 


AmplifyBio Discovery, Optimization, and Characterization

An outsourced R&D solution for benchmarking next-generation therapeutics


AmplifyBio Safety, Efficacy and Toxicology

A preclinical CRO built for the future on a decades-long foundation of expertise and experience


AmplifyBio Manufacturing Enablement Center

A manufacturing partnership for multiple modalities, offered in flexible contract staffing models to fit varied requirements

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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.