Contract Manufacturing of Prepared Solutions
For R&D and Manufacturing of
Regenerative and Cell Therapy MedicineContract Manufacturing
of Prepared Solutions
Drawing on years of manufacturing expertise and a proven track record, we provide contract manufacturing services for prepared solutions tailored to customer requirements such as compound type, volume, and concentration. In addition to products for research and testing, we also offer customized products for use as raw materials in cell manufacturing. If you have concerns or frustrations about the specifications, control methods, or manufacturing environment of your research reagents, we encourage you to consider our CTMaterial™ Grade.
Many regenerative and cell therapy medicine are manufactured in cell processing facilities (CPFs) or isolators. Because these cannot be sterilized by γ-ray irradiation or filtration, the raw materials must reduce microbial contamination and be confirmed to be sterile.
Our contract manufacturing service for regenerative and cell therapy medicine prepares solutions and performs filtration in a manufacturing environment with strictly controlled cleanliness, delivering products that meet sterility test requirements.
In close consultation with our customers, we design product specifications that consider ease of introduction into CPFs or isolators, as well as ease of use as raw materials. We support a wide range of specifications and applications, so please feel free to contact us.
5 Key Features
Leveraging Our Analytical Technology to Perform Concentration Testing
Solutions Tailored to Your Application (Research use, raw material use, etc.)
Seamless Support from Procurement and Manufacturing to Testing and Delivery
Ready-to-use: No preparation required
We Can Accommodate Items Not Listed in the Catalog
Customization Options
- Application: Research/testing use, raw material for cell manufacturing
- Composition / Concentration
- Test Items
- Product Volume (μL to mL)
- Product Container (tubes, bottles, etc.)
- Stability Testing (duration, test items, etc.)
We also welcome customization requests in addition to those listed above.
Product Testing
Product testing is tailored to each product's characteristics. We welcome inquiries about additional testing requirements not included in the list below.
| Test Item (Example) | Test Method |
|---|---|
| Sterility Test | Membrane Filtration Method (JP) |
| Bacterial Endotoxin Test | Turbidimetric Method (JP) |
| Mycoplasma Test | PCR Method (JP / In-house Method) |
| Concentration | HPLC |
| pH | Electrode Method |
| Osmolality | Freezing Point Depression |
Manufacturing Environment
- Filtration and dispensing are conducted in a Class 100 environment located within a Class 10,000 cleanroom.
- Environmental monitoring of the filtration/dispensing operations can also be performed (airborne bacteria, settling bacteria, surface bacteria)
Service Flow
Please provide a summary of your requirements and the work you would like to outsource.
We will gather detailed information on your required specifications and schedule.
We propose product specifications and a schedule along with a quote.
We procure supplies and raw materials, then carry out manufacturing and testing.
We deliver the product to you.
We also offer contract manufacturing services for pharmaceutical raw materials. For details, click here.