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- Pharmaceutical CMO service and development of API and intermediates <General Name > organic synthesis
Pharmaceutical CMO service and development of API and intermediates <General Name > organic synthesis
Service overview
AGC Chemicals offers everything from the development of original pharmaceutical ingredients to quality-controlled stable production of pharmaceuticals and intermediates on a contract basis using our systematic management system.
AGC Chemicals has a prolific track record in halogenation, including fluorination, and ultra low temperature reactions, and respond appropriately to the diverse needs of customers globally.
For contract manufacturing of pharmaceuticals, we have the plants in Chiba and Wakasa, Japan and the plant in Malgrat de Mar, Barcelona, Spain and we also handle risk dispersal using the multiple bases.
Features
- Fluorinated synthetic technologies -
AGC Chemicals handles fluorinated synthetic technologies as follows:
· Various types of fluorinating agents (HF, F2 gas, nucleophilic / electrophilic fluorination agents)
· Innovative fluorination technology - PERFECT method* (* The method that converts arbitrary hydrocarbon compounds into perfluoro compounds)
· Use of plentiful fluorine-containing building blocks
- One-stop solution including everything from development to manufacturing -
AGC Chemicals is equipped with contract manufacturing capabilities able to handle various needs based on cooperation with group plants.
Wide ranging and flexible manufacturing is possible from small scale (mg size) to manufacturing scale (ton scale).
We are able to conduct contract manufacturing of high quality active pharmaceutical ingredients and intermediates based on efficient process development through the provision of a one stop solution process from development (non-clinical) to commercial manufacturing.
- cGMP compliance / FDA inspection experiences -
AGC Chemicals offers high quality, stable production based on systematic management systems.
In response to requests, we also comply with cGMP plant manufacturing and FDA inspections.
- Global support system -
AGC Chemicals has operating bases in Japan, U.S. (PA) and Holland.
We also can adequately support global contract manufacturing.
Manufacturing bases / equipment
＜ AGC Chiba Plant ＞ (Ichihara City, Chiba Prefecture) *cGMP compliant equipment
| Material | Volume | Number | |
|---|---|---|---|
| Reactors | Glass Lining (GL) | 1,000 ~ 15,000L | 10 |
| Hastelloy C | ~ 5,000L | 2 | |
| SUS | 2,000 ~ 10,000L | 4 | |
| Filter / Dryers | Glass Lining (GL), Hastelloy C, SUS | - | 8 |
| Distillation Towers | SUS | 2,500 ~ 5,000L | 2 |
| Micronizer | Jet mill (～8㎏/ｈ), Pin mill (15~20㎏/ｈ) | - | 2 |
Environment management level: The plant has manufacturing rooms with 100,000 particles / ft3
We are equipped with chemical reactors and peripheral equipment appropriate for fluorination.
Filter dryer
Conical dryer
Clean bench
< AGC Wakasa Chemicals: Obama Plant / pharmaceuticals Plant > (Obama City, Fukui Prefecture)
- cGMP compliant
- Starting materials and raw materials
| Equipment | Material | Volume (L) | Numbers | Design Temp. (°C) |
|---|---|---|---|---|
| Reactors | SUS, Glass Lining, Hastelloy C, Resin | 100 to 5,000 | 45 | -50 to 210 |
| Distillation Towers | SUS, Glass Lining | up to 2,000 | 2 | - |
| Centrifugal separators | SUS, Resin | up to 48inch | 8 | - |
| Mixed dryer | SUS, Glass Lining | 300 to 2,000 | 4 | - |
| Filter dryer | SUS | 300 to 1,700 | 4 | - |
AGC Wakasa Chemicals is capable of synthesizing from 1 kg to 100 t centered on pharmaceutical / agrochemical intermediates
AGC Wakasa Chemicals has equipment capable of manufacturing pharmaceutical ingredients.
< AGC Wakasa Chemicals: Kaminaka Plant > (Wakasa-cho, Mikata Kaminaka-gun, Fukui Prefecture)
- Intermediates and active ingredients
- Agrochemical CDMO
| Equipment | Material | Volume (L) | Numbers | Design Temp. (°C) |
|---|---|---|---|---|
| Reactors | SUS, Glass Lining, Hastelloy C, Alloy | 200 to 14,000 | 49 | -45 to 250 |
| Distillation Towers | SUS, Glass Lining | up to 8,000 | 7 | - |
| Centrifugal separator | SUS, Resin | up to 48inch | 8 | - |
| Mixed dryer | SUS, Glass Lining | up to 4,000 | 7 | - |
AGC Wakasa Chemicals has equipment responsive to increased demand for agrochemical intermediates and ingredients.
< AGC Pharma Chemicals Europe > (Malgrat de Mar, Barcelona, Spain)
- cGMP compliant
- Designed to handle small molecule APIs from development phase to commercial scale
- Solid track record in Authority Inspections with no critical observations since 2007:
- - 6 times by FDA, latest 2018
- 3 times by EMA, latest 2018
- 9 times by PMDA, latest 2017
- ISO 14001:2015 and ISO 45001:2018 Certified
- - AGC Pharma Chemicals Europe EHS Policy (PDF)
- ISO 14001 Certificate (PDF)
- ISO 45001 Certificate (PDF)
| Equipment | Material | Volume (L) | Numbers |
|---|---|---|---|
| Reactor | Glass lined, Stainless, Hastelloy | up to 6,000 | 48 |
| Distillation tower | Glass lined, Stainless | up to 4,000 | 4 |
| Centrifuge | Stainless, Hastelloy, Halar coated | Φ 1 - 1.4m | 13 |
| Paddle dryer | Stainless, Hastelloy | up to 3,500 | 6 |
| Tumble dryer | Glass lined, Stainless, Hastelloy | 2,000 | 5 |
| Filter dryer | Stainless, Hastelloy | up to 2,500 | 5 |
| Thin layer dryer | Stainless | 4m2 | 1 |
| Micronization unit | Stainless | OEB4 (1 to 10 μg/m3) | 1 |
Special technology
AGC Chemicals is a fluorine chemical manufacturer with vast experience in fluorine chemistry and is equipped with world leading technological and production capabilities able to handle the 4 main halogens. We have a prolific track record in halogenation, including fluorination, and ultra low temperature reactions, and respond to the diverse needs of customers.
■ Halogenation
Halogen exchange reactions
Nucleophilic fluorination
Electrophilic fluorination
Diazo fluorination
“PERFECT” process
Electrolysis fluorination
Apart from the above, reactions using anhydrous fluoride (HF), fluorine gas (F2),tetrafluoroethylene (TFE), chlorotrifluoroethylene, (CTFE) and iodine pentafluoride (IF5), etc., are also possible.
■ Ultra low temperature reactions
Down to a minimum temperature of -100°C
■ Use of fluorine-containing building blocks
Heterocyclic compounds
Fluoroalkyl group introduction
■ Various types of organic synthesis
Friedel-Crafts
Grignard
Various types of cross coupling
Oxidation
Reduction (hydrogenation)
High pressure reactions (toxic / combustible high pressure gas)
High temperature reactions
- Photoreactions (e.g.: using UV, etc.)
- Polypetides / oligomerization
- Polymer reactions
- Optically active compounds (enantioselective synthesis)
- Terminal functional group protection
- Distillation (atmospheric distillation, pressurized distillation, vacuum distillation, extraction distillation, water steam distillation)
- Granulation
- Pulverization
- High purity refining
- Use of ion-exchange resins / ion-exchange membranes
- High vacuum
- Use of membrane technology
- Gas phase thermal decomposition reaction
Environment measures
AGC Chemicals has activated sludge waste water treatment equipment, HF-containing waste gas treatment equipment and organic fluorine compound incineration equipment.
cGMP
AGC Chemicals offers contract manufacturing of cGMP-compliant high order intermediates and active pharmaceutical ingredients.
We are also able to handle ultra low temperature (-100°C) reactions and reactions at high pressure (0.99 MPa) under GMP, and are able to pack out products in manufacturing clean rooms with an environment management level of 100,000 particles / ft3.
Within the plant
QC Laboratory
Ultra low temperature reaction equipment
Inquiries
