One-stop Peptide Platform
cGMP Peptide APIs Manufacturing
Manufacturing capacity
  • SPPS, LPPS, ligation chemistry, and fragment condensation methodologies
  • All protecting strategies (Boc, Fmoc, Cbz) can be used
  • Process development and scale-up competence ensure a robust commercial process
  • GMP batch sizes from gram scale to multi-kilogram scale (5kg/batch)
  • IQ, OQ, PQ qualified equipment
  • Class 100K and 10K clean room
cGMP compliance
  • Biopeptek cGMP quality program strictly follows FDA cGMP guidance
  • -
    Code of Federal Regulations Part 210/211 (21 CFR 210/211)
    - ICH Q7
Peptide CMC
  • Comprehensive peptide process development capability
  • GMP manufacturing capacity
  • Our injectable platform provides formulation development and manufacturing for a solution, emulsion, lyophilized powder, and liposome in the vial, prefilled syringe, and cartridge.
  • Service overview: Biopeptek has a dedicated peptide analytical team of 70+ scientists with extensive experience and expertise to support all peptide analysis at all development phases. Our analytical service will streamline your peptide development with customized, flexible, and integrated analytical solutions.
  • Biopeptek’s regulatory team offers documentation support for IND and NDA applications globally. Our team has experience preparing Module 2 and Module 3 of your regulatory dossier.
Research Peptide
Quality Assurance
  • Our independent Quality Assurance team ensures full cGMP compliance through entire process.
The GMP Testing Procedures and Specifications Include The Following:
  • Appearance
  • Solubility
  • Peptide purity (HPLC)
  • Related substances (HPLC)
  • Molecular weight (MS)
  • Peptide content
  • Amino Acid Analysis
  • Counterion content
  • Moisture content (Karl Fisher)
  • Residual Trifluoroacetic acid
  • Residual organic solvents
  • Bioburden
  • Endotoxin
Inspried by Patients.
Driven by Science.