Partner 8Octane Biotech Inc, Kingston, Ontario, Canada

Octane Biotech Inc., part of Octane Medical Group, is a profitable Canadian corporation focused on innovative products for regenerative medicine. Based on core strength in product development and manufacturing, the company has a successful track record of taking new technology from concept through validation to full commercialisation.

One technology pillar of Octane is focused on proprietary systems for the automated manufacture of cell-based products for clinical applications. This R&D programme is delivered by a multi-disciplinary team comprising biological scientists, mechanical, electrical and computer engineers, software programmers and instrumentation technologists. The team is supported by Octane’s manufacturing and quality group and operates within the Company’s ISO & FDA registered production facility.

The team has 15 years of experience in developing and deploying bioreactor technology for cell culture and tissue engineering. Initially developed for microgravity applications (in collaborative projects with the Canadian and European Space Agencies and NASA), Octane's advance bioreactor platform has been designed with the flexibility to address multiple clinical applications. Particular focus has been on:

  • adaptive control of bioreactor environments,
  • multi-stage bioreactor sequencing to effect complex cell manipulations,
  • disposable bioreactor cassettes that provide rigorous protection from cross-contamination.

In addition to its cellular implant experience, Octane Medical Group has commercially launched multiple products for skeletal reconstruction and has products sold internationally through marketing and distribution partnerships with leading international medical companies. Octane has strong knowledge of FDA and EMA regulatory standards (including ATMP) and has implemented extensive bioprocess validation programmes focused on GMP production. 

Role in the project: Octane will provide technical support for design validation, manufacturing transfer and regulatory approval. It will be active in developing and qualifying the automated bioreactor system and will deliver regulatory analysis and compliance advice related to the bioreactor, the cell product output and the processing environment. Octane will also lead the strategic planning thrust of the Work Package focusing on commercialisation goals, market positioning and business development.