Stock Codes:
002821.SZ / 6821.HK
GLP1R single target
Dual target / triple target peptides
Arginine rich peptides
Thioether bridge, disulfide bridge
Amide bond bridge, carbon carbon bond bridge
Carbon carbon bond, amide bond
Enzymatic cleavage / lipid modification
PEGylation / N methylation
PDC (molecular weight 1000 to 4000)
RDC precursors and stock RDC
Chelators & PSMA inhibitors
500+ experienced process, analytical scientists, engineers and manufacturing teams
More than 50 IND and more than 10 late stage projects (including 3 PPQ projects) manufacturing and regulatory submission experience
Adoption of green processes, delivering viable implementation pathways for sustainable development
Leveraging deep understanding of compliance and regulatory filings to mitigate and reduce CMC risks
Continuously committed to applying new technologies to peptide R&D and manufacturing
Chiral amino acid analysis platform
Systematic synthesis, purification and separation equipment, meeting the needs from laboratory to commercial production
Peptide Fragment Banking
Extensive component library
High throughput screening
Multi element collaborative optimization technology
Tool enzyme library with high stability, high activity and high adaptability
Efficient host engineering and regulation technology
Custom development of recombinant peptides:
1 to 3 months
Gram scale samples from initial strain development
3 to 7 months
Scale up process development and optimization, establish robust commercial process routes
We have conducted in depth expression optimization and protein engineering modification on a series of key enzyme preparations, and established a commercial tool enzyme library with high stability, high activity and high adaptability. This library includes more than ten commonly used tool enzymes such as Kex2 protease, Carboxypeptidase B and Trypsin, ensuring efficient application in large scale production and providing strong and reliable support for the manufacturing of protein and peptide drugs.
With deep accumulation in the field of enzyme engineering, we have successfully established innovative solutions for enzyme modification, avoiding the impact of amino acid side chain groups during chemical modification. This enables precise site specific modification (such as C terminal amidation and N terminal acetylation) and closed loop one stop recombinant synthesis of peptide drugs.
We provide high quality recombinant protein drug and peptide microbial fermentation services at scales ranging from 5L, 50L, 500L to 5,000L.
Method development: tailored and robust method development strategies are formulated based on peptide properties (such as hydrophobicity, charge and stability) and in reference to ICH Q14
Method Validation: Conduct comprehensive validation (including specificity, accuracy, linearity, LOD/LOQ, etc.) in compliance with ICH Q2(R1) and pharmacopoeia requirements to ensure the compliance of release and stability indicating methods.
Method transfer: transfer protocols (comparative testing, co validation) are formulated to ensure reliable operation of methods between different laboratories
Method Optimization & Troubleshooting: Resolve challenges with customers’ existing methods or optimize their performance.
Sequence confirmation, peptide mapping, modification identification (phosphorylation, glycosylation, etc.), disulfide bond localization and impurity characterization
Accurate molecular weight determination and complex structural elucidation
Amino acid composition and quantitative analysis
Amino acid composition and quantitative analysis
Physical property studies, including physical state, melting point, solubility, pH value and hygroscopicity
Identification Tests: peptide mapping, molecular weight, amino acid composition, etc.
Purity and impurity analysis: Combining multiple chromatography column modes to achieve impurity separation and quantification (including chiral, diastereomeric impurities, process impurities such as residual ions, residual solvents, metal elements), missing peptides, truncated peptides, insertion peptides analysis, as well as degradation impurity research and aggregate / oligomer detection and analysis
Assay determination
Biological activity
Other Tests: including appearance, water content, residue on ignition, inorganic ion/elemental impurities, residual solvents, peptide content/purity analysis, amino acid ratio, etc.
Microbiological testing: Bioburden (complying with USP/EP/Ch.P standards), bacterial endotoxin (LAL gel clot method, kinetic turbidimetric method and recombinant factor C technology), etc.
Calibration of Primary Reference Standard
Preparation, calibration and management of Working Reference Standard
Isolation, purification, characterization and calibration of impurity reference standards
Design and execute stability study protocols (accelerated, long term, intermediate conditions) in compliance with ICH Q1A(R2)
Provide stability indicating methods
Periodic testing of critical quality attributes (CQAs) to evaluate degradation pathways and rates
Prepare professional stability study reports to support IND/NDA submissions.
Solid data integrity foundation: in compliance with ALCOA principles (including computerized systems, electronic data and paper records)
Sound quality management system: a management system established based on cGMP regulations, including deviation, change, OOS/ATR procedures, internal audits and supplier management
Extensive audit experience
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