Licensed GMP manufacturing and process development for clinical trials and commercial supply

Cell Therapies has been on the forefront of developing and executing clinical trial and commercial GMP manufacturing of cell-based products since 2003.  We have experience across a wide range of cell types, from mesenchymal stromal cells to chimaeric antigen receptor T-cells and offer full “needle-to-needle” process control – from patient cell collection back to reinfusion to the same patient.

In addition to our GMP manufacturing expertise, we offer the following capabilities:

  • Process development and optimisation – ranging from process flexibility and rapid process scale-up for early stage clinical products, to cost reduction and standardisation for late-stage/commercial products
  • Technology transfer – efficient translation of client requirements into and out of our manufacturing facility, including testing, documentation, and process flows to ensure successful translation between sites
  • Storage and distribution logistics – validated liquid nitrogen storage of cell products to meet regulatory requirements, along with distribution partnerships to ensure critical product delivery globally

 

Cell Therapies is your partner for delivering your cellular therapy product to the patient.  Please contact us today to get started.