Service for scaling up a chemical substance

Beskrivning

Invitation to tender Karolinska Institutet, hereinafter called KI, invites companies, hereinafter called Tenderers, to submit tenders concerning pharmaceutical development through scale-up and manufacture of a chemical substance, a small molecule anti-cancer compound, according to GMP requirements. Background to the procurement Prof Thomas Helleday, The Department of Oncology and Pathology, has recently discovered a highly potent small inhibitor of MTHFD2 which shows promise in several cancer models in cells and rodents. The next step is to take this inhibitor through GLP toxicology studies and IND filing before entering first-time-in man studies. To do this The Helleday Lab wish to procure the active pharmaceutical ingredient (API) from a contract manufacturing organization, that has certified regulatory experience in the GMP synthesis of highly potent compounds. Agreement term KI has intention to sign a contract with one (1) supplier. The agreement period is (4) years.