Work: experience from
Leukotech, a startup biotech company.

Work: experience from Leukotech, a startup
biotech company.

Leukotech A/S is a biopharmaceutical start-up company that researches and develops agents to prevent and treat life-threatening infections and severe inflammatory disorders. The company focuses on gene technology, mammalian cell culture, protein purification and characterization, analytical chemistry, and immunochemistry. The company is based in Copenhagen, Denmark.

Leukotech

• Set up sterile cell culture production of 100 mg protein/day in hollow fiber technology with continous harvest

• Have put a clean room in successful operation with utilities and sterile procedures in a very short time

• Implemented a complete environmental monitoring program

• Established a highly productive Master Cell Bank

• Set-up of a full blown Down Stream Process of purification of the harvested protein with 4 filters, an- and cat-ion exchange, gel filtration chromatography and virus filtration

• Set up of a complete analysis programme: HBP-ELISA, IL-6 ELISA, SDS-PAGE (PHAST), IEF, Glucose and lactate determination, UVmeasurement

• Developed a smart and cheap GMP-system in preparation for inspection to obtain a production license for bulk for clinical trials

• Prepared a complete toxicological programme including GLP

• Examined the entire development process concerning regulatory and agency requirements

• Set up sterile cell culture production of 100 mg protein/day in hollow fiber technology with continous harvest

• Have put a clean room in successful operation with utilities and sterile procedures in a very short time

• Implemented a complete environmental monitoring program

• Established a highly productive Master Cell Bank

• Set-up of a full blown Down Stream Process of purification of the harvested protein with 4 filters, an- and cat-ion exchange, gel filtration chromatography and virus filtration

• Set up of a complete analysis programme: HBP-ELISA, IL-6 ELISA, SDS-PAGE (PHAST), IEF, Glucose and lactate determination, UVmeasurement

• Developed a smart and cheap GMP-system in preparation for inspection to obtain a production license for bulk for clinical trials

• Prepared a complete toxicological programme including GLP

• Examined the entire development process concerning regulatory and agency requirements