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委托生产

我们拥有长年累月所积累下来的合成技术,可以随需求满足从工艺开发到GMP委托生产。

GMP少量生产设备的完备,结合上我们已经拥有的GMP大型设备及多功能性设备,
使得我们能够灵活应对从数百克到大批次的生产。
基于ICH-GMP的标准,通过DMF和CEP的注册,FDA审查等经验,使得我们拥有了过硬的品控管理体制,
可以提供让客户满意的委托生产服务。
另外,我们在EHS投资方面也是不遗余力。

Contract Manufacturing Flow
Contract Manufacturing Flow
Main Facilities
Pilot Plant
FacilitiesSpecificationCapacityQuantity
Reactors
Normal Pressure, -5~140℃(200℃)
Glass Lining 10L 5
Glass Lining 300L 5
1,000L 1
Stainless 300L 3
500L 1
Autoclave
~10kg/cm2, -5~140℃
Stainless 200L 1
Vacuum Distilling Apparatus
3mmHg, ~200℃
Stainless 200L 1
Centrifuge Top emission type, Stainless φ12 inches 1
φ20 inches 2
φ30 inches 1
Filter Separators Pressurization, Stainless 2
Reduced pressure, Stainless 2
Dryers Shelf- fan dryer, Stainless-steel 1
Shelf-type vacuum dryer, Stainless 1
Conical type vacuum dryer, Stainless 30L 1
Clean Room Clean level: 100,000/ft3
Ventilation: 20 times/hr or more
1
Freezer
Medium -20℃
3600kcal/hr 1
Commercial Plant
FacilitiesSpecificationCapacityQuantity
Reactors
Normal Pressure~100mmHg, -5~140℃(200℃)
Glass Lining 2m3~10m3 41
Stainless 1m3~10m3 67
Ti clad 2.5m3 2
Autoclaves
~10kg/cm2, -5~140℃
Stainless 2m3~4m3 5
Glass Lining 4m3 1
Photo-reactor
600〜700nm
Stainless
Sodium Lamp
1
Vacuum Distilling Apparatus
3mmHg, ~180℃, N=12
Stainless 1m3~7m3 3
Centrifuges Bottom emission type, Stainless φ24~55 inches 5
Top emission type, Stainless φ24~55 inches 21
Filter separators Pressurization, Stainless 18
Reduced pressure, Stainless 29
Reduced pressure, FRP 1
Dryers Shelf-type fan dryer, Stainless 22
Conical type vacuum dryer, Stainless 2~2.5m3 6
Clinical type vacuum dryer, Glass Lining 2m3 2
Nauta-type vacuum dryer, Stainless 1m3 3
2m3 5
Mills Pin mill, Stainless 9
Hammer mill, Stainless 3
Power mill, Stainless 1
Feather mill, Stainless 1
Jet mill, Stainless 1
Clean Rooms Clean level: 100,000/ft3
Ventilation: More than 20 times/hr
Centrifuge rooms 10
Drying rooms 11
Milling rooms 12
Ice Maker Stainless 2.4t/day 1
Wastewater treatment Activated sludge
Freezers Medium -20℃
Inside -10 ~ -5℃
46kW 16
Main Analytical Equipment (Shizuoka Factory)
We have necessary analytical equipment for product quality control.
We operate accordance with data integrity.
We can use the equipment of R&D in Tokyo depending on the customer’s requirements.
EquipmentSpecification
HPLC High and low pressure gradients
Detector: UV, UV-VIS, RI
GC Detector: FID
Equipped with a head-space sample injection device
ICP-MS Responding to elements subject to ICH-Q3D Step 4
Responding to organic solvents
FT-IR 7800~350cm-1
UV-visible spectrophotometers 190~900nm
Karl Fischer moisture meter Volumetric procedure
Coulometric titration
Potentiometric titrator pH 0.00~14.00
Polarimeter 589nm (Na)
Particle size distribution analyzer Laser diffraction type(dry and wet), microscope type, air permeability method
Main Reactions
Technologies in orange highlighted are our specialty technologies.
AcylationAcid chloride, acid anhydride, etc.
AmidationAmmonia, amines, etc.
AminationBy reduction of nitro and nitroso, and by using amines
AlkylationDialkyl sulfuric acid, alkyl halide, etc.
EsterificationVarious organic and inorganic acids, and alcohol
ReductionBy catalytic hydrogenation, using NaBH4, sulfurous acid, etc.
Grignard reaction
ChlorinationNaOCl, SOCl2, PCl3, POCl3, etc.
Enantiomer synthesisAsymmetric reduction, Optical resolution
Enzymatic reactionAsymmetric hydrolysis, hydrolysis
Kolbe-Schmitt reactionCarbon dioxide
OxidationUsing H2O2, NaOCl, etc.
DiazotizationNaNO2
Cyanation-CONH2 → -CN
Suzuki-Miyaura couplingR-B(OH)2, Pd/C
SulfonationSulfuric acid, fuming sulfuric acid, sulfur trioxide-pyridine complex
NitrationNitric acid, mixed acid, etc.
NitrosationNaNO2
GlycosidationBF3, methanesulfonic acid
Photo-oxidationSodium lamp
Friedel–Crafts reactionAcylation, Alkylating
BrominationBr2
FormylationHCHO, Vilsmeier reaction, etc.
Mitsunobu reaction
PhosphorylationPOCl3, PCl3
Other organic synthesis reactions
Our technology
Catalytic reduction
We have well knowledge and many experiences of actual production relating to catalytic reduction.
We will select and provide the best reduction condition based on customer’s reaction.
In addition, we have established safe and reliable handling operations from charging to recovery.
We have also realized cost reduction through recycling in collaboration with catalyst manufacturers.
Catalytic reduction
Example of catalytic reduction
Example of catalytic reduction
Photo-OxidationBromination
Photo-Oxidation We have bromine tank system, so we can use bromine itself. Bromination
Friedel-Crafts ReactionKolbe-Schmitt Reaction
We use Aluminum Chloride.
We have know-how on removing by-produced Aluminum Hydrochloride. Friedel-Crafts Reaction
Reaction can be made under mild condition. Kolbe-Schmitt Reaction
Suzuki-Miyaura Coupling
We can manufacture in actual equipment based on know-how regarding the use of Pd catalyst. Suzuki-Miyaura Coupling

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