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.
Driven by Science.
