Drug Substance Development & Manufacturing

Available from Ardena
Product Menu
View Company Profile View all Products

Product Details

Guiding you through your early phase development journey, from drug substance to clinic.
Drug substance development and production is the foundation on which pharmaceutical product development is built. The ability to make consistent drug substance batches is key to turning a compound that shows promise in the laboratory into an effective and safe product.

Our process development and scale up activities also comprise process safety investigations. If a totally new process needs to be designed because of economic or safety reasons, we perform route scouting to identify the best possible synthesis route for your compound. We can scale up your process in our GMP Kilolab and in our state of the art GMP pilot plant facilities. We offer drug substance manufacturing services to support your toxicology and clinical studies with batch sizes up to 50 kg.

Our analytical sciences team develops and validates all methods up to the standards required for the stage of development. We also offer release and stability testing of drug substances. Our goal is to meet our customers’ demands for high quality drug substances and to provide them with the data they need to win regulatory approval. Our analytical laboratories are equipped with a wide range of highly advanced technologies that are capable of precision drug substance assessment and characterization.

Rate and Review Ardena - Drug Substance Development & Manufacturing

No reviews yet.

Let users know what you would have wanted to know about this company.