Recombinant Growth Factor Therapeutic

Client Objective

Vybion developed and produced a recombinant growth factor for scale up and use in clinical trials.

 

 

The Results

Vybion optimized the gene, which was cloned into Pichia pastoris.

Fermentation, downstream processing and purification protocols were developed and optimized.

Vybion developed a complete documentation package and supported the IND and Health Canada submission.

Vybion was approved by Health Canada for production of phase I clinical trials material.

Vybion used the same development clone for a second client for a separate therapeutic area.

The recombinant growth factor developed by Vybion is currently in phase I and III clinical trials for separate and unrelated indications.