Peptide can be used for biological function analysis, but also has a high biological activity, low toxicity, high specificity and other inherent characteristics. The use of peptides in clinical applications is increasing every year. Dozens of peptides are already marketed as drugs and hundreds more are in different stages of clinical development. When implemented in the early stages of peptide drug development, custom cGMP peptide synthesis can help expedite the maturation of your peptide drug.
Our GMP Service Package Includes
Process development
Impurity study
Isolation and identification of known and unknown impurities
Analytical development and characterization
Analytical validation
Full stability studies
Process validation
Drug Master Files (DMFs)
Regulatory support
Preparation and characterization of an in-house reference standard
Our Standard cGMP Specifications Include
Appearance
Solubility
Identity
Peptide purity
Related substances
Assay
Bacterial endotoxins
Counterion content
Water
Mass balance
Specific rotation
Residual organic solvents
FEATURES
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Technology Platform
Raw material qualification
Synthetic method development, validation and scale up
Product purification
GMP/GLP analytic method development and validation
Release specification design and testing
GMP packaging
GMP Compliance
On-going training
In-house audit
Raw material control
Analytical method validation and documentation
Standard operating procedures (SOPs)
In process control and batch record
Certificate of Analysis for GMP Peptides
Appearance and solubility
Purity by HPLC
Heavy metal analysis by ICP-MS
Bioburden or microbial tests
Residual organic solvent by GC
Amino acid analysis
Molecular Weight by MS
Water content
Endotoxin
Peptide content(nitrogen estimation)
Counter ion content(% TFA) by IC
After-sales service
Problems submitted in 1-2 weeks, we provide free-issue retest ,and refund for unqualified products. Ineligible goods retesting in 1-3 month free.
Technical support
Our technical support permanent, customers enjoy experienced technical experts one to one service.