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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 a few thousands of scientists with state-of-the-art equipment. Specific to peptide API process development, we have a highly experienced R&D team with more than a few hundreds of 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, 12 lines with wide range of synthesizers from 20 L to 1,000 L, including:

Two  500 L synthesizers

Five 1,000 L synthesizers

So the overall Solid Phase Peptide Synthesis (SPPS) total reactor volume is up to 6,490 L.


Liquid phase peptide synthesis

  • Route design and protection strategy selection for a wide range of peptides

  • Quality by design(QbD) to support LPPS process performance qualification

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

  • LPPS and SPPS combined approach for complex peptides synthesis

  • Both batch mode and flow mode

  • Hydrogenation capable

Access to new technologies

Liquid Phase Peptide Synthesis

Biocatalysis

UF/DF

Spray Dried Dispersion

Precipitation