Chitose Hamari’s High Potency Drug Substance Manufacture Facility

Chitose Hamari’s peptide production facility for high potency drug substances has been operational since 2016. The facility is equipped with a clean room. Small peptides are manufactured under strict cGMP. Mid-length to long peptides from 10 to 30 residues, cyclic peptides, peptide conjugates, etc. can also be manufactured. Moreover, to respond to the increasing market demands for injection-grade APIs, the containment and cleanliness control systems was upgraded for high potency injection-grade peptides in February 2019. Chitose Hamari will evolve with your needs!

 
 
 

Equipment Overview

Cleanliness Class
Class C (ISO7)
Temp./Humidity
22±3℃, 30±15%RH
Primary Contain.
Balance enclosure, safety cabinet
Secondary Contain.
Pressure controlled room, HEPA, emergency decontamination mist shower
Exposure Mgmt.
OEL 1 to 10 μg/m3, Category 4 (Pharma Solutions Co., Ltd.’s Classification)
Batch Size
grams to 1 kg
Production Line
1 line
Manuf. Equipment
Solid-phase reactor (10 L), liquid-phase reactor (20 L), automated HPLC purification system, lyophilizer (flask manifold / tray), shunt-flow precision humidity generator

automated HPLC purification system

manufacture area

product room