Production process ready for transfer to GMP manufacture
This spring, Spago Nanomedical initiated an expanded production campaign based on an upscaled manufacturing process optimized with regard to execution, quality and yield. The campaign, which is now completed, has in a cost-efficient way resulted in a sufficient amount of the product candidate SN132D to accommodate the regulatory preclinical studies. It has also generated strategic competence for the transfer of the production to an industrial GMP manufacturer.
”To sum up this campaign, more than 2 kg of SN132D has been produced and sent for regulatory preclinical studies. We succeeded in transferring an advanced laboratory method to a production process fit for industrial manufacture. In addition, we have an excellent documentation package to support tech-transfer of the process to a certified contract manufacturer who will produce material for the upcoming clinical trials. This is a considerable risk reduction in the project and marks a clear transition for Spago Nanomedical. We are now a development company!”, says Oskar Axelsson, CSO Spago Nanomedical.
The procurement process and tech-transfer to an industrial contract manufacturer has been initiated.