Insulin Degludec

Insulin Degludec is an ultra-long-acting basal insulin analogue used to control high blood sugar in people with diabetes.
Developed by Novo Nordisk under the brand name Tresiba, it is administered via subcutaneous injection. Unlike other long-acting insulins, Insulin Degludec provides a steady level of insulin in the body for an entire day, with a duration of action that lasts up to 42 hours. This makes it a once-daily basal insulin that provides a ‘background’, slow-acting supply of insulin1.

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 active ester derivative of Hexadecandioyl-Glutamic acid linker is performed at 15 grams scale with the yield of at least 30%.
Attachment of active ester Hexadecandioyl-Glutamic acid active ester linker to
DesB30 Human Insulin (1.5 gram scale) is performed to obtain Insulin Degludec.
Analitycal RP-HPLC analysis of the reaction mixture is perfomed.
Preparative RPHPLC separation/purification of Degludec yields at least 20% in respect to recombinant Human Insulin Precursor.

Diabetes Management: Insulin Degludec 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. It has a duration of action that lasts up to 42 hours, making it a once-daily basal insulin.