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Advanced Modalities: mRNA, Cell and Gene Therapy Manufacturing Services

Capacity available in multiple cGMP suites equipped for cell therapy, plasmid manufacturing, viral and non-viral gene editing processes, and (coming soon) mRNA manufacturing. Offered in multiple staffing models, AmplifyBio’s goal is to offer a complete partnership model to scale up advanced therapy products, with the support of our R&D and commercial operations team that has a proven track record of bringing drugs through IND, through commercial scale manufacturing, including PAI readiness

Advanced therapies experience 400% more chemistry, manufacturing, and control (CMC) related developmental disruptions when compared to other large molecule biologics such as mAbs. Robust characterization integrated into a manufacturing strategy will ensure the PRODUCT is the PRODUCT. 

A New Manufacturing Paradigm

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. Instead, drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.  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.  The result is a lower-risk, more efficient product development lifecycle with less surprises during manufacturing scale-up or scale-out and clear measures of safety and efficacy. 

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 bring your team. 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 play a role in setting up, personnel training, and executing development and/or manufacturing processes while relying on AmplifyBio’s scientific and support staff to create the perfect team for the task at hand. This is especially valuable during pilot and early production when changes are common, and processes are still being defined. Leverage our experience to enable process and product robustness. 

Full-Service Partner Model

In this model, clients work handinhand with AmplifyBio to develop a robust operating plan, and then trust AmplifyBio with all aspects of execution of the drug development and manufacturing plan. From initial concept to final product, this model allows clients to focus on other critical aspects of their business, knowing they are leveraging decades of experience to execute on a commercially viable plan. 

cGMP Quality Support

In all three models, your product will benefit from our full GMP quality support and any input from our technical operations and development teams you need.AmplifyBio staff have extensive experience in GMP analytical services to support manufacturing efforts, clean room support, technology transfer, process development, analytical development and validation processes, QMO automation (ask us about this), compliance, supply chain management, definition and support of release specs across the manufacturing process, maintenance of equipment, and QMS /documentation support.   

GMP Facility

  • Qualified, calibrated, and maintained equipment
  • Controlled rate freezing
  • LN2 freezer storage
  • Electronic batch record option
  • Cleanroom environment monitoring
  • USP utility monitoring

In-Process Testing and Lot Release

  • Flow cytometry-based cell phenotyping
  • Payload expression
  • Cell counting and viability
  • Cytokines by ELISA / ELLA
  • Cytokine bead array
  • Gel Electrophoresis
  • UV Spectroscopy
  • qPCR
  • Virus Copy Number
  • Mycoplasma
  • Rapid sterility testing
  • Bioburden

Plasmid Manufacturing

AmplifyBio’s manufacturing services also extend to the design and production of DNA plasmids, whether you are using them directly for gene delivery or using them for critical raw materials for viral vector or mRNA drug products. Our plasmids are available in a range of quality and types to meet research goals across stages and at a smaller scale, typically used in earlier stage development.   

  • Research Use Only Plasmid 
  • Preparatory (prep)-GMP
  • Full GMP Plasmid

AmplifyBio plasmid manufacturing services benefits from the same combined team experience and industry-leading quality systems experienced in our other manufacturing areas.  

Contact Us

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.