Phase 1 of the 350,000-square-foot manufacturing facility will open in the first quarter of 2024. It will include standalone B- and C-grade suites that can be configured to accommodate any modality and simultaneously produce multiple lots. The manufacturing suites are complemented by quality, process development, and expansive analytics laboratories staffed by experts at AmplifyBio to ensure that clients have access to a development “sandbox” of assay platforms, technologies, and expertise anchored in experienced GMP quality assurance and facility management.
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.
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.
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.