Menu
Capacity available in multiple cGMP suites set up in ballroom or multi-room configurations and equipped for cell therapy, plasmid manufacturing, viral and non-viral gene editing processes, and mRNA manufacturing. These suites are located in the South San Francisco facility, at the same site as AmplifyBio’s R&D team, which specializes in target discovery and characterization services. Multiple staffing models are offered for optimal partnerships to scale up advanced therapies.
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.
