We have professional and experienced engineers and scientists, providing new polypeptide drug biosynthesis solutions, which help partners stay ahead of the polypeptide drug discovery, clinical development and market production.

We have more than 5000 square meters of R&D center and 20000 square meters of intelligent manufacturing base, which can meet the needs of different customers and products, while meeting the GMP conditions for drug production.

 

XIUSHI Biopharma is a CDMO specializing in the manufacturing of synthetic peptides and oligonucleotides for early-phase, late-phase development, and commercial production. XIUSHI Biopharma excels in large-scale, late-phase, and commercial production, boasting the production capability in kgs quantities.


We specialize in contract development and manufacturing organization ("CDMO") services, which include peptide chemistry, manufacturing, and controls ("CMC") development; as well as contract manufacturing organization ("CMO") services, encompassing peptide new chemical entities (NCEs) and generic drug commercial manufacturing.


XIUSHI Biopharma provides a comprehensive peptide-centric CDMO platform with vertically integrated capabilities in peptide drug development and manufacturing, adhering strictly to Good Manufacturing Practice (GMP) standards mandated by major regulatory authorities globally.


GMP Compliance
XIUSHI Biopharma's GMP program strictly adheres to FDA/EU GMP guidelines.


Code of Federal Regulations Part 210/211 (21 CFR 210/211) and
ICH Q7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7)