The production of pharmaceutical products is highly regulated by health authorities worldwide. Before clinical trials with new Immunodrug™ candidates can be performed, the drug candidate has to be manufactured in accordance with Good Manufacturing Practice (GMP), a suitable formulation has to be developed, and the product has to undergo toxicity and stability testing.

Cytos Biotechnology has built up the in-house expertise and infrastructure required to move novel drug candidates from the research stage through to clinical development. The capabilities comprise process and analytical development as well as GMP-compliant manufacture of the active pharmaceutical ingredients (APIs) used for clinical trials in its own in-house production facility. Cytos Biotechnology’s quality management system is regularly inspected by both its partners and the health authorities and a  manufacturing license has been obtained from the Swiss Agency for Therapeutic Products (Swissmedic) for the manufacture of drug substances for clinical trials.

In addition, Cytos Biotechnology has established a fruitful collaboration with a leading custom manufacturer – Lonza – for the manufacture and supply of the Immunodrug™ carrier Qb. Under the agreement, the microbial manufacturing process for Qb has been upscaled to a scale suitable for late-stage clinical trials with Immunodrug™ candidates, as well as for potential in-market supply. Lonza will supply Cytos Biotechnology and optionally also its Immunodrug™ collaboration partners with the carrier Qb. This collaboration with a leading company in the field of biologics manufacturing gives Cytos Biotechnology access to expertise and large-scale production capacity and will ensure that future demand for the Immunodrug™ carrier Qb, the core of the Immunodrug™ platform, will be met.

 

For further information on Cytos Biotechnolog's GMP Production read more...