Custom Peptide Synthesis
Peptide CMC
Catalog Peptides
cGMP Peptide APIs Manufacturing
Overview
Manufacturing capacity
01
SPPS, LPPS, ligation chemistry, and fragment condensation methodologies
02
All protecting strategies (Boc, Fmoc, Cbz) can be used
03
Process development and scale-up competence ensure a robust commercial process
04
GMP batch sizes from gram scale to multi-kilogram scale (5kg/batch)
05
IQ, OQ, PQ qualified equipment
06
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
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