Chitose Hamari’s High Potency Drug Substance Manufacture Facility

High potency drug substance manufacture equipment improvements!!
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 are being improved to support US-FDA Guidance on high potency injection-grade peptides (operational in January 2019). Chitose Hamari will relentlessly evolve and expand to meet your needs!

 
 
 

Construction Outline

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
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