Semaglutide

Semaglutide

Description of Semaglutide

Semaglutide is a recombinant human glucagon-like peptide-1 (GLP-1) analogue, belonging to the class of GLP-1 receptor agonists (or GLP-1 RAs). Novo Nordisk developed three formulations of semaglutide already available in the market: Ozempic and Wegovy (injection formulation) and Rybelsus (oral tablet).

Ozempic and Rybelsus are indicated for glycemic control in type 2 diabetes mellitus patients, while Wegovy is for weight management in obesity or overweight patients.

Synonyms

Semaglutide, Ozempic (injectable formulation for glycemic control), Wegovy (injectable formulation for weight management), Rybelsus (oral semaglutide), NN9535, NNC0113-0217, CAS 910463-68-2, UNII-53AXN4NNHX

Amino Acid Sequence of Semaglutide

Semaglutide is a well-designed long-acting GLP-1 (7-37) analogue based on liraglutide. Semaglutide differs from liraglutide in two sites. Position 8 is replaced by Aib(U)——a modification that significantly protects it from enzymatic degradation by the dipeptidyl-peptidase 4 (DPP-4). In addition, the modified fatty acid chain and two PEG2 intermediates are optimal for prolonged efficacy both in vitro and in vivo.

Fig 1. Structure formula of Semaglutide

Formulation of Semaglutide

Expression system

Yeast

Manufacturing Process of Semaglutide

Drug Substance Manufacturing

Yeast fermentation and culture broth harvesting

Purification to produce pure peptide backbone (also called GLP-1(9-37) or semaglutide precursor)

Peptide modification and purification to form active substance

Drug Product Manufacturing

Aseptic Fill-Finish: Preparation of formulation and filling it into cartridges, followed by finishing

We also offer One-Stop CDMO Solution for Semaglutide

• Microbial Strain Engineering and Screening
• Microbial Cell Banking (PCB/MCB/WCB)
• Upstream Process Development
• Downstream Process Development
• Formulation Development
• GMP Manufacturing
• Fill and Finish
• Analytical and Testing
• Regulatory Affairs