Exosome Therapeutics

Codiak, Clinical Manufacturing Facility

The goals of this project were to assess current process manufacturing design and capabilities and identify future space and organizational needs.
About this project

Codiak is engineering exosomes – nature’s intercellular messengers – to advance an entirely new class of medicines, exosome therapeutics.

DPS provided the process and manufacturing expertise and led the process engineering design effort for this project. As part of an overall design team DPS performed coordinated support, planning, and design services.

Project scope

This is a clinical manufacturing facility of around 10-12,000 sf with a flexible layout that allows utilization of a clean area for variable lines. The process utilizes a “closed” system of work packages, and all equipment is mobile.

Features include:
  • 250L scale fed-batch process with flexibility
  • Next generation perfusion upstream and connected purification
  • End-to-end disposable technology
  • No transfer piping or CIP system required
  • Pre-fabricated Pod technology utilized for clean processing areas

DPS’ focus included code and safety compliance as well as documentation of a complete facility program reflecting all manufacturing needs and full support of functional requirements. Efficient space planning and design for this GMP-compliant, improved facility, resulted in operational benefits and effective material and personnel flows.

The maximizaion of the benefits of single use equipment technology in laying out the manufacturing area and planning for materials, product transfers, and support equipment allowed efficient use of the site in overall planning and consideration for future needs.

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