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Our peptide API process development and GMP manufacturing platform provides end-to-end solution from preclinical to commercial all in one site from Changzhou China. We have built industry leading capability and capacity to support your needs across all development stages, with knowledge retention through product life cycle.

WuXi STA has an industry leading process development team of 2,000+ scientists with state-of-the-art equipment. Specific to peptide API process development, we have a highly experienced R&D team with more than 200 scientists in Changzhou site amply equipped with international standard equipment and instruments. Together with small molecule team, we provide sufficient capability and flexibility to better meet your needs.

Comprehensive Peptide Process Development Capability

We have experience in a broad range of peptide process development, including

Linear peptide

Cyclic peptide

Modified peptide

Capability of solid phase and Liquid phase chemistry

Experienced in peptide conjugation such as PPMO and peptide-toxin

GMP Manufacturing Capacity

With our global standard quality system, we are uniquely positioned to be your strategic GMP manufacturing partner for reliable, cost effective and long-term supplies of your peptide APIs from gram to metric ton scale. Our custom synthesizer and cleavage system with full containment design enhances workers safe and health operation and environmental protection without hazards exposure. The unique “one-site” platform ensures knowledge retention and seamless scale up throughout your product life cycle, and expediates your development by eliminating the need for multi companies/sites transfer.

In Changzhou site, 9 lines with various of wide range of synthesizers from 10 L to 1000 L, including:

Two  500 L synthesizers

Three  1,000 L synthesizers

We plan to add 4 additional production lines with various of scales by 2022, including two 1,000 L synthesizers

Liquid phase peptide synthesis

Process development and production for a broad range of peptide molecules

Cyclic and disulfide bridge construction

Continuous flow extraction and hydrogenation incorporated in the process

Dedicated process crystallization team, avoid most of the pre-HPLC separation

400+ modern reactors ranging from 5L to 20,000L

Peptide API process development and GMP manufacturing experience

40+ peptide GMP projects completed

Largest scale peptide projects: ~40kg/batch

2 PPQ enabling studies and 2 PPQ campaigns completed in 2020