Preclinical
Production of related substances and samples
We support research such as synthesis study of samples (FTE basis).
Contract Manufacturing of APIs
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- Our Business
- Contract Manufacturing of APIs
The production system follows
GMP/Global Quality Standards.
Supply high-quality APIs stably and continuously.
Kyowa Pharma Chemical manufactures APIs, compounds in the early stages of development, and APIs for clinical studies by using our unique chiral technologies such as enzyme reaction, asymmetric synthesis, and optical resolution methods.
In order to ensure a stable and continuous supply of high-quality APIs, we devote our total manufacturing technologies (including the design and engineering of production facilities) to establish each plant. The production systems at multi-purpose plants rationalize and optimize the process of each product, and allow us to handle large-volume batch production to low-volume production and multi-items production. Our production facilities that are rich in variety can handle a wide range of production scales. We establish flexible production systems with these facilities, and these have been well-received by a lot of our customers.
Furthermore, we have established a management system in accordance with GMP (Good Manufacturing Practice) and global quality standards.
We can respond to a wide range of customer requirements in terms of quality and pharmaceutical regulatory affairs.
Contents of Contract Manufacturing
We offer total support from early R&D to the commercial stage.
Clinical Study
Manufacturing of APIs to support clinical studies
We manufacture APIs for clinical studies using gram-scale manufacturing equipment.
Launch
Process development
We have extensive experience in the process of developing complex
and highly potent small molecules (e.g., Prostaglandins).
Contract Manufacturing of APIs
We have systems conforming to US, EU, and Japan GMP requirements.
Maturity stage
(Product Lifecycle)
Process improvement and optimization
We have achievements in process improvement using Bioconversion methods.
Development Support and Patents List
We have several patents. Our flexible technology enables support from the early stages of development.
■Patents List
- Synthesis methods
for Prostaglandins - JP 2019-131510, International Publication WO 2020/195437, pending 1
- Bioconversion
- International Publication WO 2021/132536
- Manufacturing methods
for optically active substances
（Catalyst derived from plants） - Patent No. 6678442, No. 6630667
- Supersulfides
- International Publication WO 2021/200487, and 4 applications are in process
- Cosmetics
- Patent No. 4533415, No. 4680775, and many others
■Introduction to Unique Patents
In addition to patents related to the synthesis process, we also have our own unique patents.
Asymmetric ring-opening reaction of meso-epoxides catalyzed
by water-soluble polysaccharides from soybean
Patent #: 6630667: PROCESS FOR PRODUCING OPTICALLY ACTIVE SUBSTANCE
- Developed a functional catalyst derived from a plant
- The function is present in many plants
- Components of ordinary foods can also be catalysts
- Main structural component is the “carbohydrate chain”
Property of the Catalyst
Heat resistance : Remains active at 100° C
Recycle : Possible (Regeneration treatment is NOT needed)
Physical property : Non-soluble in organic solution （Easily separable by filtration after the reaction）
Substrate specificity
Facilities and Equipment
We have a production system with comprehensive manufacturing technology, high efficiency, and environmental protection at the same time. In order to provide a stable and continuous supply of high-quality products that meet our customers' requirements, we establish plants with total manufacturing technology, including engineering technology.
Introduction to Our Facilities
| Plant A | |||
| Manufacturing products |
APIs and Intermediates | ||
| Lot size | up to 50 kg | ||
| Major facilities | Manufacturing area | Reactor |
10L, 20L, 50L [Glass flask] 100L, 200L, 500L, 600L, 800Lｘ2, 1600L, 2000L [GL] 50L, 100Lx2, 200L, 500Lｘ2, 1200Lｘ2, 1500Lｘ2 [SUS] |
| Silica gel column | 30L, 40L, 150L, 250L, 350L, 500L [SUS] | ||
| Flash evaporator | 10L ｘ 2, 50L ｘ 2 [Glass] | ||
| Rotary evaporator | 10L, 20L x 4 [Glass] | ||
| Centrifuge | 30B [SUS], 30B [Hastelloy], 36B [Hastelloy] | ||
| Conical dryer | 400L[GL] | ||
| Controlled room | Two rooms | ||
| Rotary evaporator | 1L x 3, 10L x 2 | ||
| Flash evaporator | 50L x 2 [Glass] | ||
| Lyophilizer | 40L/ batch | ||
| Plant B | |||
| Manufacturing products |
APIs and Intermediates | ||
| Lot size | up to 30 kg（300-500L） | ||
| Major facilities | Manufacturing area | Reactor |
340L (-80～120℃) [GL] , 500L (-30～120℃) [GL], 340L (-30～120℃) [GL] , 300L (-30～120℃) [SUS] |
| Portable mixing tank | 100L x 3 [SUS] | ||
| Portable tank | 200L x 2 [SUS], 200 L[Hastelloy] | ||
| Filter | 0.3m2 [SUS] x 2, 0.5m2 [SUS] | ||
| Vacuum shelf dryer | 3m2 [SUS] | ||
| Milling machine | Possess | ||
| Controlled room | Two rooms | ||
| Reactor | 300L (-25～120℃) x 2 [SUS] | ||
| Filter dryer | 0.3m2 [SUS], 0.3m2 [Hastelloy] | ||
| Plant C | |||
| Manufacturing products |
Intermediates | ||
| Lot size | up to 800 kg（3,000-10,000L） | ||
| Major facilities | Manufacturing area | Reactor |
3000L, 9200L, 10000L [GL] etc. 3000L, 6000L, 10000L [SUS] etc. |
| Reduction reactor | 4900L [GL] , 5000L [SUS] | ||
| Filter dryer | 1700L [SUS] | ||
| Centrifuge | 48B [Hastelloy] , 48B[SUS] | ||
| Conical dryer | 4000L [GL] | ||
| Plant D | |||
| Manufacturing products |
APIs and Intermediates | ||
| Lot size | up to 30kg（10-800L） | ||
| Major facilities | Manufacturing area | Reactor |
10L, 20L [GLASS] 200L, 200L, 800L [SUS] 500L, 800L [GL] |
| Filter | 20L, 70L, 120L [SUS] | ||
| Conical dryer | 450L [SUS] | ||
| Portable column | Possess | ||
| Flash evaporator | 50L | ||
| Rotary evaporator | 20L x 2 | ||
| Controlled room | Crystallization tank (Kilolab) |
20L, 50L | |
| Filter dryer | 20L x 2［SUS］ | ||
| Flexible isolator | Possess | ||
| Plant E | |||||
| Manufacturing products |
APIs and Intermediates | ||||
| Lot size | up to 800 kg（3,000-8,000L） | ||||
| Major facilities | Manufacturing area | General Work Area Zone1 | General Work Area Zone2 | ||
| Reactor |
8000L×2 [GL] 8000L [SUS] |
Reactor |
8000Lx2 [GL] 6000L [SUS] |
||
| Dissolution tank |
3000L, 5000L [GL] 3000L [SUS] |
Dissolution tank | 5000L x2 [GL] | ||
| Agitation tank | 6000L×2 [GL] | Agitation tank | 6000L [GL] | ||
| Centrifuge | 48B [Hastelloy] | Centrifuge | 48B [Hastelloy] | ||
| Conical dryer | 4000L×2 [GL] | Conical dryer | 4000L [GL] | ||
| Purified water manufacturing facility |
Possess | Purified water manufacturing facility |
Possess | ||
| Controlled room | Reactor | 8000L [GL] | |||
| Centrifuge | Φ1000 [Hastelloy] | ||||
| Conical dryer | 4000L [GL] | ||||
