tirzepatide Manufacturer

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.