Engineering Consulting Service for One Polypeptide Project

By 2022, the GLP-1 market had exceeded insulin and led the entire market for diabetes treatment. Data revealed that the global diabetes drug market reached USD 59.618 billion last year, of which GLP-1 sales reached USD 22.6 billion (with Semaglutide sales reaching USD 8.574 billion). In the same period, the market scale of diabetes drugs in China reached approximately CNY 86.2 billion, and it is expected to reach CNY 167.5 billion by 2030. It can be seen that the Chinese market will be an attractive blue ocean in this valuable industry.

Project Background

The client is a national high-tech enterprise committed to peptide industrialization in China. Its main business includes the R&D, production, and sales of peptide APIs, cosmetic peptide ingredients, and functional skincare products. It also provides peptide drug CRO/CMO/CDMO technical services. As a key supplier for Novo Nordisk and leading cosmetics companies such as P&G, the client is currently planning a three-phase project covering an expansive area exceeding 600 acres. This initiative aims to establish the largest peptide industrial park and a central research institute for peptides in China. The product portfolio spans various areas, utilizing both solid-phase and liquid-phase chemical synthesis pathways for peptide production. The products include popular GLP-1 drugs like Semaglutide and Liraglutide, indicating the company's commitment to developing peptide technologies in the pharmaceutical and cosmetic industries.

Scope of Service

• Overall planning for the Phase I project, including site master plan, staging strategy, and overall facility automation control.

• Design review of GMP-related functional areas to ensure that pollution prevention, cross-contamination, mix-up, and error measures have been adequately considered in the design phase, thereby ensuring product quality.

• Process design, equipment layout, personnel flow, clean utility systems, HVAC systems, and design of high-potency areas shall comply with the specifications of NMPA, EMA, and FDA cGMP.

AUSTAR Value and Client Benefits

• We have experience with international insulin projects.

• Also project experience in EMA, FDA, and NMPA standards.

• Experience with insulin projects involving both fermentation and synthesis processes.

• EMA, FDA, and WHO simulation inspection and solutions.

• Engineering solutions based on science and risk: Risk assessment, engineering solutions, and compliance validation.

• International experts.