LOCATIONS and CAPABILITIES

Cognate’s state of the art 80,000+ square feet (and growing) cGMP facility is strategically located in Memphis, TN USA – a worldwide air hub for FedEx, enabling Cognate to send and receive shipments from anywhere in North and South American and Europe within 24 hours, with multiple choices of carriers. This enables Cognate to efficiently and effectively handle both fresh and frozen products of all types.

Cognate has separate R&D, assay development, and process development laboratories in Baltimore, MD.

Compliant cGMP Facility and Systems

  • 80,000ft2+ and growing fully qualified U.S. FDA and EU Annex I cGMP cell isolation and expansion facility with three different suite configurations.
  • Licensed and inspected by Tennessee State Board of Pharmacy as well as the U.S. FDA with no 483 findings, as well as an EU cGMP certificate enabling release of products into the EU.
  • Multiple class 10,000 (ISO 7) production/cell culture suites supported by individual air handling systems.
  • Full service PD, QC, QC analytical and QC micro laboratories for all standard analytical in-process and release testing and routine monitoring of production suites.
  • Validated—Siemens APOGEE Building Monitoring system for all critical systems, equipment and environmental chambers.
  • Robust planning and scheduling systems.
  • QA systems including: orrective Action and Preventive Action (CAPA) Program, Vendor Audit Program and Change Control.
  • Cryogenic storage, distribution, and tracking systems.

 

MEMPHIS, TN CLINICAL AND COMMERCIAL cGMP MANUFACTURING:

This facility was originally a purpose built-out for autologous cell therapy manufacturing. In 2007, Cognate acquired the manufacturing capacity in Memphis and has since manufactured for many clients in various phases of clinical work and a variety of cell types. Our largest phase of clinical grade production was an autologous product for phase III clinical trials, mostly manufactured in Memphis with products shipped to more than 80 clinical sites in four countries. This facility supported technology transfer and external manufacturing in close collaboration with partner facilities in Germany and England.

Today we have a team of 270+ members. The majority of the Cognate team is staffed in Memphis and is focused on manufacturing., The balance of the team is in Baltimore and is focused on PD/AD/TT. Cognate’s Memphis facility is <5 miles from FedEx’s North America super hub and near several life science facilities, University of Tennessee, and St. Jude Children’s Research Hospital. Our proximity to the North American distribution hub insures drop off of patient material in the evening and delivery anywhere in North America by next morning, and enables support of shipment to and from North America, South America and Europe within a 24 hour window.

BALTIMORE, MD ASSAY DEVELOPMENT, PROCESS DEVELOPMENT AND R&D

Located near Baltimore Washington International Airport is Cognate’s GLP laboratory facility containing our growing team of process and assay development experts, as well as a team focused on efficient technology transfer of the work performed in Baltimore into our GMP manufacturing units in Memphis. Our facility is geographically situated in Baltimore because of longstanding relationships with NIH, John’s Hopkins and University of Maryland Medical Center as well as various biotechnology companies in the Eastern corridor.

Please contact us to discuss our comprehensive capabilities with automated systems, assay development, closing systems and state of the art analytics.

Cognate Offers the Broadest Array of Experience and Services

Key Management and Technical Personnel With Average of 15 Years Experience in Cell Therapy Manufacturing Development:

  • Master and working cell banks
  • Fill finish services
  • Process development and scale-up
  • Genetically modified cells and/or irradiated cells (on-site irradiator)
  • FDA Investigational New Drug CMC Packages and equivalent documentation for International Regulatory Agencies
  • Stability and shipping studies (nearly 24 hour shipping possible, via proximity to FedEx hub)

Clinical and Commercial Manufacturing

  • Process transfer, optimization and validation
  • Large-scale cGMP-compliant cell and cell-mediated gene therapy manufacturing for autologous and allogeneic products from a variety of starting sources (development and implementation of efficient and effective scale up, at the right time developmentally)
  • Ability and expertise to manufacture both adherent and suspension based cells
  • Packaging, storage and shipment to US and international clinical sites (5 minutes from worldwide FedEx hub in Memphis)

Process and Assay Development and Optimization

  • Cell product characterization, in process QC testing, analytical development and optimization, assay scale up, assay validation, and lot release assays for identity, purity and potency and other measures as appropriate for living cellular product characterization.
  • Method development for scale up, technology innovation, equipment and/or closed system integration
  • Development and integration of fully custom automated or unit based automated solutions
  • Third party vendor collaboration for custom technology development
  • Qualification and validation for pivotal trials or registration

Logistics, Supply Chain and Manufacturing Support Services

  • The isolation, expansion, packaging, release and delivery of living cellular therapies involves many ancillary services including but not limited to: supply chain integration, complex scheduling with several parties (clinical sites for example), temperature and/or controlled storage before during and after shipping, and various shipping and logistics providers as it pertains to different stages of product between the patient-to-patient pathway
  • Interfacing with additional CMO’s and/or regulatory agencies for global clinical trials and/or product roll-outs
  • Cognate can manage all aspects of the product development lifecycle. Please contact us for more detail on the services we provide to our clients

Clinical, Regulatory and Custom Services

  • High quality products can rapidly become low quality products if they aren’t handled appropriately once they leave our facility. Clients who want to ensure that only the highest quality of products get administered to patients often consult with us to help educate the clinical sites on handling the products once they arrives on site.
  • Cognate’s long history of dealing with multiple regulatory agencies at various stages of clinical and commercial development can be leveraged by our clients to help establish or augment the clients’ respective regulatory and/or clinical packages.
  • With rapidly evolving technology, it is imperative that clients have access to a CDMO with experience across several sectors and at all stages of development—in addition to a fundamental commercial mindset. Cognate has the experience to understand and foresee how changes can impact products. Our custom services help our clients effectively bridge the gap between the known and unknown, or current state and future state.
  • So whether it’s a new assay, new sampling plan, new storage procedure and/or process, or a new device that needs to be modified to scale, or a new element of creating a closed manufacturing process that’s required, Cognate can help. No problem too small or too large for Cognate.