GMP Peptide Synthesis


  • 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

Highlight


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.

Certificate of Analysis includes MS and HPLC analyses performed after the completion of peptide synthesis, purification, and QC (quality control) steps. These analyses are followed by independent QA (quality assurance) procedures, guaranteeing the highest quality of peptides.

Analysis List


  • Chromatography (HPLC, TLC, GC, IC)
  • Chromatography coupled to MS (LC-MS/ESI)
  • Spectroscopy (UV-Vis, IR, NMR)
  • Refractometry
  • Polarimetry
  • Metallic Analysis (AAS, ICP, ICP-MS)
  • Elemental Analysis
  • Titration (Acid-Base Titration, Karl Fischer Titration)
  • Amino acid analysis

Quote
  1. For quotation requests and questions, you may contact us by email, phone, or via our online quotation system.
  2. Orders can be placed by phone, email, fax, or online with a formal Purchase Order or credit card.
  3. Please send your samples to ABclonal, 86 Cummings Park Dr, Woburn, MA 01801, United States.
  4. Our customer service is available 24/7.