Contract Manufacturing

The CoImmune team has 17 years of experience in the development of cellular based therapies. We provide comprehensive services with multifunctional experienced project teams helping customers accelerate their product development through transition from bench to an industrial setting, and then to Phase I-III clinical development. Our focus on research and development aims at helping customers to fill existing gaps. Our objective is to deliver quality products that meet customer’s expectations.

To evaluate whether the CoImmune team can assist you, please contact us to receive a request for proposal template.

Capabilities

Logistics

  • Kit production, labeling and clinical supply
    • Assuring clinical supply of kits for delivery of biological products including international deliveries
  • Chain of identity systems
  • Cold chain transport and logistics

Warehouse storage and management

  • Quarantine and controlled monitored storage at ambient, refrigerated -20, -86 and ultra-deep freeze conditions in agreement with biological and chemical safety standards. Inventory management system with cycle counting capabilities.

Manufacturing

  • Eleven ISO 7 manufacturing suites. Teams experienced in production of cellular as well as RNA based starting materials.

Project management

  • Strong point of contact with our customers. Operating a cross functional team at CoImmune tailored to the needs of the specific program. Regular and transparent communication with our customers.

Research and Development

  • Our expertise in cellular immunology and molecular biology with proven record of publishing our own science in peer reviewed journals is available to help customers for rational, science-based development of their products and process as well as quality tests and monitoring during clinical trial.

Immunomonitoring

Qualification/validation

  • Equipment qualification per user requirements, calibration and validation. Routine maintenance and periodic review.

Quality control

  • Two quality control laboratories equipped to support environmental monitoring program, in-process and release testing of cellular product and recombinant nucleic acid based products, stability programs, raw material qualification. Expertise in the development, qualification and validation of novel assays.

Outsourcing

  • Our extensive experience with outsourcing of programs such as recombinant DNA production, cell banking and stability programs is available to support customer needs.
17
Years

Experience