Service & Products
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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