PIC/S GMP MANUFACTURING
We offer a one-stop shop service to support your product from research to commercialization.
KriSan Biotech has a comprehensive GMP quality system and experienced experts in GMP production. With 6 GMP production lines for multiple use, it can produce small molecule, peptide and oligonucleotide. The production lines for Antibody-drug conjugate (ADC) and High Potency API (up to OEB 6) are under construction.
Each production line has independent walk-in fume hood, dedicated filter, glove box isolator and vacuum drying oven. All equipment has been qualified to meet international regulatory requirement (PIC/S GMP): Design Qualification(DQ), Construction, Commissioning and Installation Qualification (IQ), Operation Qualification (OQ), Performance and Process Qualification (PQ)