A New CDMO Experience: AMEC

A hybrid approach to manufacturing is transforming the landscape of cell and gene therapy manufacturing. At AmplifyBio, we redefine CDMO services by eliminating the traditional “buy vs. build” trade-offs. Our innovative hybrid model integrates seamlessly with your team, giving you greater control over manufacturing processes and timelines while optimizing the cost of goods. By combining the expertise of a leading CDMO with the flexibility and customization of in-house operations, we empower you to accelerate the development and delivery of advanced therapies with unmatched efficiency and scalability

Amplify Manufacturing Enablement Center (AMEC)

Modular Design for Scalable Growth:

  • Facility built in separate modules with independent suites.
  • Scalable footprint allows phased implementation and seamless growth from pilot to commercial.
  • Faster startup times and reduced timelines for increasing batch cadence.

Customizable and Flexible Configurations:

  • Phase 1 includes standalone B- and C-grade suites designed for flexibility.
  • Suites can be configured to support any modality, enabling simultaneous production of multiple lots.
  • Opportunities for client input, such as Galapagos, in suite expansion and design.

cGMP Quality Support

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.   

 

  • Qualified, calibrated, and maintained equipment
  • Controlled rate freezing
  • Cryo freezer storage
  • Sample management facility
  • Validated electronic inventory management control
  • Electronic batch record option
  • Cleanroom environment monitoring
  • USP utility monitoring
  • 2000 sq ft outfitted Quality Control Laboratories
  • In-process and release testing
  • Lot characterization capabilities:
    • Bioanalytical methods
    • Molecular biology methods
    • Cell therapy methods

A CDMO Facility Built To Accomodate Innovative Staffing

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.

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. 

Contact Us

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.