Main Site for R&D and Investigational New Drug Manufacturing

At Amagasaki Office, we conduct pharmaceutical product development and manufacturing of investigational new drugs, as well as development of new technology, utilizing our rich experience in global new drug development.

Amagasaki Office photo

1-3, Kuise Terajima 2-chome, Amagasaki, Hyogo 660-0813 Japan
+81-6-6401-1221

Japan
PMDA
Jul. 2020
USA
FDA
Jun. 2016

R&D

We can provide services for any of clients’ needs around pharmaceutical CMC research and development activities, such as API and process development, formulation development, package development, development of analytical methods and specifications and regulatory application support.

Investigational New Drug Development

API

API Manufacturing Building A

Building A is our manufacturing plant for investigational new drugs and intermediates. The plant has 2 multi-purpose manufacturing lines for API and intermediates and ISO class 7 clean room to enable trial manufacturing of a wide range of drugs.

Major Facilities

Manufacturing Area	Reactor with Distiller (200~500L GL·SS) Reactor (300~800L GL) -70˚C Low Temperature Reactor (300L GL) Medium Pressure Reactor (500LGL) Centrifuge (30inch TL) Conical Dryer (400L GL)
Clean Room (ISO Class7)	Reactor Distiller (300L GL) Centrifuge (24inch TL) Dryer (Blender 150L GL)

※GL: Glass Lining, TL: Teflon Lining, SS:Stainless Steel

API Manufacturing Building B

Building B is for manufacturing of investigational new drugs and intermediates and with 3 manufacturing lines, it has a larger manufacturing capacity than Building A. The manufacturing equipment line-up includes state of the art PAT equipment such as FBRM (Focused Beam Reflectance Measurement) to enable real time process monitoring. The clean room is equipped with Jet Mill to handle clients’ requests from manufacturing to pulverization of investigational new drugs.

Building B

Major Facilities

Manufacturing Area	Reactor Distiller (200~1000L GL·SS) Filter (150~330L SS,TL) Centrifuge (24,30inch TL) Conical Dryer (300L 500L GL)
Clean Room (ISO Class7)	Reactor Distiller (1000 GL) Centrifuge (30inch TL) Conical Dryer (500 GL) Pulverizer (Jet Mill SS)

※GL: Glass Lining, TL: Teflon Lining, SS:Stainless Steel

Formulation and Packaging

Formulation and Packaging/Manufacturing Building

Formulation and packaging/manufacturing building is seven stories high. The lower levels are primarily for manufacturing and experimental area for investigational new drug dosage and packaging specifications design, whereas the higher levels are primarily GMP manufacturing area for drug formulation and packaging with focus on investigational new drugs.

Major Facilities

Aseptic Filling Lyophilization	Vial Washer Vial Dry Heat Sterilizer Vial Filler Vial Accumulator Lyophilizer Capper Rubber stopper washer sterilizer Autoclave
Pulverization	Spiral Jet Mill Sample Mill
Granulation	10L Type Agitating Granulator 50L Type Agitating Granulator Constant Temperature Unit for Agitating Granulator Cylindrical Granulator 5L Type Fluidized Bed Granulator Dryer 30L Type Fluidized Bed Granulator Dryer
Sizing	Power Mill Fitz Mill
Mixing	10L Total Capacity V Type Mixer 22L Total Capacity Agitating Granulator 100L Container Mixer
Dry Granulation	Roller Compactor
Capsule Filling	5 Type Capsule Filler Capsule Deduster Capsule Weight Classifier
Compression	12 Station Compression 45 Station Compression External Lubrication system for tableting
Spray Dry	Spray Dryer (Organic Solvent Capable)
Coating	48 Type Coating 80 Type Coating
Packaging	Semi-automatic PTP Packaging (Sealer) Semi-automatic PTP Packaging (Trimmer) Table-top Vacuum Sealer Table-top Sealer/Labeler Multi-purpose Labeler for Multiple Product Types

Analysis

In addition to quality testing of investigational new drugs, we can provide various services around quality from investigational new drug API and formulation analysis methods and standards design appropriate for each development stage, stability testing for regulatory application, approval application, and to transfer of analysis technology to commercial manufacturing locations.

Major facilities

Physiochemical Analytical Instruments	Liquid Chromatograph (HPLC,UPLC)/Mass Spectrometer Particle Size Analyzer Gas Chromatograph/Mass Spectrometer Tablet Hardness Tester Ion Chromatograph ICP-MS (Inductively Coupled Plasma Mass Spectrometer) Nuclear Magnetic Resonance Spectrometer ICP-AES (Inductively Couples Plasma Atomic Emission Spectrometer) X-ray Powder Diffractometer UV-Visible Spectrophotometer IR Spectrophotometer Polarimeter Dissolution Tester Electrical Conductivity Meter Disintegration Tester Water Activity Meter Total Organic Carbon Analyzer Surface Area Analyzer Karl Fischer Moisture Meter Light Obscuration Fine Particle Counter Potentiometric Titrator others
Microbial Testing Instruments	Aseptic Testing Isolator Genetic Analyzer Endotoxin Analyzer Airborne Bacteria Analyzer Ethylene Oxide Gas Sterilizer others
Surface Area Analysis Instrument	Scanning Electron Microscope
Sample Storage	Low Temperature Thermo-Hygrostat Prefabricated Thermo-Hygrostat Photostability Testing Chamber others