Insulin Detemir

Insulin Detemir is a long-acting human insulin analogue used to maintain the basal level of insulin in individuals with diabetes mellitus. It is designed to have a predictable, flat and prolonged duration of action. Insulin Detemir is produced through recombinant DNA technology and differs from human insulin by the removal of threonine in position 30 of the B chain, and the addition of a C14 fatty acid chain. These modifications provide it with its unique time-action profile. It is administered subcutaneously and is typically used in combination with short-acting insulin or other non-insulin antidiabetic medications.

Transfer of the end-to-end technology available in GMP-like environment.

Preparation, purification and isolation of Human Insulin DesB30 by protease
digestion of recombinant Human Insulin Precursor is performed at 2.3 grams scale
with the yield of at least 50%.
NB: the recombinant Human Insulin Precursor necessary for Human Insulin
DesB30 preparation is previously produced in Pichia pastoris using an expression
vector pPIC9K (Cat. No. V175-20, Invitrogen, CA) driven by the AOX promoter and
induced by methanol.
Preparation of Tetradecanoic acid 2,5-dioxo-pyrrolidin-1-yl active ester linker
(Myr-OSu) is performed at 10 grams scale with the yield of at least 60%.
Attachment of Myr-OSu linker to DesB30 Human Insulin is performed to obtain Insulin Detemir.
Preparative RPHPLC separation/purification of Detemir yields at least 20% in respect to recombinant Human Insulin Precursor.

Diabetes Management: Insulin Detemir is used to control high blood sugar in adults and children who are 1 year of age and older with diabetes mellitus. It provides a ‘background’, slow-acting supply of insulin. Due to its long-acting nature, Insulin Detemir provides low concentrations of background insulin that can keep blood sugar stable between meals or overnight. This makes it an essential part of long-term management of diabetes.