Drug Filling Facility

Dalton is a leading custom peptide synthesis company. Our GMP peptide synthesis operation uses state of the art equipment for the mass production, purification, and QC of synthetic GMP peptides.

Terminally Sterilized and Aseptically Processed Parenteral , Sterile Fill, Sterile Liquid Fill and Drug Filling Capabilities:

Our automated, barrier isolated, small scale drug filling line can fill vial sizes that are 30 to 145mm in height and 8 to 62mm in diameter. The line is capable of drug filling up to 8000 vials per day depending on the fill volume and vial size required. The drug filling area maintains a static and operational Grade A (ISO Class 5) environment. All areas of the sterile fill manufacturing facility—including ancillary support areas—are routinely monitored for viable airborne contamination, viable contamination on surfaces and non-viable airborne contamination by our QC Microbiology Laboratory. The area is supported by our Analytical Chemistry Laboratory and Quality Assurance Department.

Validated drug filling process equipment includes a depyrogenation oven and a steam sterilizer.The sterilizer is fed by a pure steam generator, which is fed by our USP Purified Water system. All process equipment is routinely monitored for quality and performance. Filling operations are supported through validation services that include but are not limited to: thermal mapping of oven and steam sterilizer load configurations using state of the art data logging equipment, biological indicator studies, container closure integrity studies, aseptic process simulation studies (media fills), process validation and cleaning validation. Dalton presently has 1 GMP product in Phase I, and 2 GMP products in Phase III. We are manufacturing and filling Virulizin® for Lorus Therapeutics to be used in pancreatic and skin cancer treatment.