Semaglutide Intermediate (Recombinant)

Basic Info

Semaglutide is a new 2nd Generation GLP-1RA drug developed by Novo Nordisk. In Dec. 2019, Semaglutide injection (brand name: Ozempic, 4mg/3ml) was approved by FDA to improve glycemic control in adults with type 2 diabetes. In Jun. 2021, Semaglutide injection (brand name: Wegovy, 2.4mg/dose) was approved by FDA to treat obesity (BMI≥30kg/m2) and overweight (BMI≥27kg/m2).

Peg-Bio’s Semaglutide intermediate (P29, also GLP-1 K34R (9-37)) is a 29 amino acid peptide developed via TE-PEP® recombinant E. coli expression. (TE-PEP® is one of Peg-Bio’s proprietary technology platforms, featuring high efficiency and high-density tandem expression of peptides.) The molecular structure of P29 is C142H216N38O45 and its CAS no. is 1169630-82-3, with a molecular weight of 3175.50 Da.

Features

FDA DMF ready, DMF#: 039617.

High yield rate based on our patented Tandem Expression of Peptides (TE-PEP) technology: 12kg intermediate per batch (3,000L fermentation scale), with annual output up to 400kg.

Animal origin free: manufactured via recombinant technology, without exogenous virus contamination. No material of animal origin is used.

The production workshop operates according to GMP, and the production equipment, environment, and process control are implemented in accordance with Good Manufacturing Practice.

Regulatory support documents available according to customer needs.
Customized packaging specifications available according to customer requirements.

Packaging & Transportation

This product is in lyophilized powder and is packed in HDPE bottles for oral medicines, convenient for transportation and storage. It remains stable for at least 24 months stored under -15 C or below. IMED provides cold chain transportation, with data logger monitoring temperature from delivery to receipt of goods.