North American CDMO to receive EMA approval for a commercial allogeneic drug product
batches produced over the past four years
INDs submissions supported
global cell therapy clients from early phase to commercial
Memphis, TN CDMO Facility Overview
With the ability to perform 100% of testing onsite, our integrated CDMO cell and gene-modified cell therapy offerings include clinical and commercial manufacturing for both autologous and allogeneic therapies from early to late phase through commercialization. As part of our integrated CDMO solutions, processes are optimized and transferred into our documentation and quality systems for GMP readiness.
Memphis Overview
- Manufacturing Facility
- 4600 E. Shelby Drive
- 100,000+ square feet/7,400+ square meters
- GMP Warehouse
- 5780 E. Shelby Drive
- 50,000+ square feet/4,600+ square meters
- Close proximity to FedEx global SuperHub and Memphis International Airport serving all major US airports overnight and major European hubs
- Experience working with many couriers
- Dedicated training areas to maintain proficiency of personnel and drive proper skill adoption for new hires
- Staff
- 240+ employees
- 25+ purpose-built aseptic cGMP manufacturing suite configurations for scalable needs
- Validated ISO 7 Grade B production suites that are both US FDA and EU Annex 1 compliant for cell culture
- Validated ISO 7 Grade B containment production suites that are both US FDA and EU Annex 1 compliant for cell culture or viral transduction with negative pressure anterooms
- Separate raw material warehouse for controlled materials management and storage, providing just-in-time storage of released materials at the primary manufacturing facility
Experience and Capabilities
- Autologous and allogeneic cell and gene-modified cell therapy products
- Experience with diverse range of cell types and cell-based technology platforms, including immunotherapies, such as CAR-T therapies, NK cells, B cells, Dendritic, and CD34, as well as primary cells
- GMP manufacturing
- Regulatory support, including Chemistry, Manufacturing, and Controls (CMC) authoring and review, Investigational New Drug (IND) applications, and Biologic License Application (BLA) submissions
Cell Therapy Process Development
- Cell selection and enrichment
- Gene editing and viral transduction
- pDNA and vector production
- Cell culture and expansion
- Harvest, formulation, fill and finish, and cryopreservation
- Tech transfer/feasibility studies
- Proof of concept studies
- Irradiator (xRAD)
- Optimization
- Scale-up/scale-out
- In-process characterization (critical quality attributes) studies
- Off-the-shelf process platforms
- Stability studies
- Fully automated and closed process
Cell Therapy Assay Development Services
- De novo development
- Characterization
- Panel development
- Platform transfer
- Non-radioactive alternatives
- Material compliance
- Proof of concept studies
- Assay categories
- Safety (sterility)
- Purity
- Identity
- Potency/functionality
Testing Services
- Qualification
- Validation
- Assays
- Cell function
- Viability
- Proliferation
- Cytotoxicity
- Cell differentiation
- Growth inhibition
- Apoptosis
- Cell killing
- Cytokine characterization
- Custom assay support
- Microbiology
- Rapid sterility
- Rapid mycoplasma
- Rapid endotoxin
- Gram stain
- Physiochemical testing
- Osmolality
- pH
- Appearance/visual inspection
- Microbiology
- Cytokine ELISA
- Endothelial Cell Density Analysis
- Immunocytochemistry
- Equipment (not exhaustive list)
- Cell counter
- Flow cytometer
- Hematology analyzer
- Real-Time PCR thermal cycler
- PCR thermal cycler
- Immunoassay instrument
- Multi-mode plate reader
- Plate reading scintillation counter
- Comparability
- Stability studies
Our CDMO facility in Memphis operates in compliance with the following regulatory agencies or accredited organizations:
- Good Manufacturing Practice (GMP)
- Food and Drug Administration (FDA), USA
- European Medicines Agency (EMA)
- Health Canada
Accelerated CGT production timelines
Already validated processes and protocols seamlessly move clients from onboarding to manufacturing and commercialization.
Commitment to the highest quality standards
Ensuring the highest level of product quality and patient safety.
Dedicated team from day one
Our customer-centric approach provides project and timeline alignment.
Efficient and effective manufacturing
Phase-appropriate, GMP manufacturing for scale-up and scale-out.
CGT Manufacturing Scale Up Resources
While manufacturing hurdles are widespread, the industry as a whole is determined to manufacture life-changing cell and gene therapies to make them accessible to patients in need. This determination is why we've cultivated the most pertinent resources from our experts on key considerations, innovative technologies, and tips on meeting regulatory requirements in your CGT scaling up processes strategy.
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