Take your results from the lab to the pilot. We have an expert staff dedicated to the design and development of an economical, reproducible, robust and scalable synthetic route that ultimately will obtain a product that complies with the market’s strict purity requirements.
The objective of the work was the production of GMP batch for phase I clinical trials.
AIMS
· Biotech company in Spain moving product into Phase I.
· Synthesis developed by another CRO transferred to pilot plant for the GMP batches.
· Backup supplier, competing with a top-class GMP supplier.
ACTIONS
· Scale up and process development, optimizing critical reaction steps and developing analytical methods under regulatory framework.
ACHIEVEMENTS
· GMP batches (30 Kg) and regulatory analytical package delivered on time.
· Better results than top-class GMP supplier (which delivered no product).
Get more information about our services on Process Development here.
