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Peptide CMC
Peptide Discovery
Peptide CMC
Peptide Conjugation
Amino Acid
Case Study
API
API
Drug Product
Analytical
CMC Filing
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.
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
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.
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
Liquid Phase Peptide Synthesis
Biocatalysis
UF/DF
Spray Dried Dispersion
Precipitation
