Modular Design for Scalable Growth:
Customizable and Flexible Configurations:
In all three models, your product will benefit from our full GMP quality support and any input you need from our technical operations and development teams. AmplifyBio staff has extensive experience in GMP analytical services to support manufacturing efforts, clean room support, technology transfer, process development, analytical development and validation processes, QMO automation, compliance, supply chain management, definition and support of release specs across the manufacturing process, maintenance of equipment, and QMS/documentation support.
AmplifyBio offers a range of flexible manufacturing models to meet diverse client needs. Our hoteling option allows clients to fully occupy the facility from manufacturing suites to a dedicated “client village” for office functions. In the Hoteling model, they can fully manage and execute all aspects of their production. For those seeking a more traditional approach, our full service traditional CDMO services offer a solution where AmplifyBio managing every aspect of the process. Finally, our hybrid model combines the best of both worlds, allowing clients to integrate their teams and processes with our infrastructure and expertise for a collaborative and customized manufacturing experience.
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.
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.
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.
Choose AmplifyBio as your trusted CDMO partner to bring your cell and gene therapies, mRNA, and plasmid DNA manufacturing to the next level. With our expertise, innovative facilities, and comprehensive CDMO services, we ensure your therapy development journey is efficient, scalable, and successful.