We offer a GMP-grade plasmid production service for the manufacturing and quality testing of plasmid DNA as a raw material or drug substance (e.g., DNA vaccines).
- Gram-scale production
- Manufactured in 25 L, 2 x 25 L, or 200 L single-use systems, or 2,000 L bioreactor
- Our unique high-density culture technology ensures a high-quality product
We offer a GMP-grade mRNA production service for the manufacturing and quality testing of mRNA as a material for use in vaccines and other pharmaceuticals.
- mRNA production using a single-use system
- Scale up from the initial development of manufacturing methods
- GMP-compatible quality tests and characteristic analyses
Viral vector production
- Retrovirus (Master Cell Bank, Working Cell Bank)
- Adeno- and adeno-associated viruses
Our T-cell processing service provides you with gene and cell therapy products as well as expert support in entering the clinical market. We have expertise in:
- T cells
- NK cells
- Mesenchymal stem cells
With our cell banking services, we will deliver a high-quality Master Cell Bank (MCB) from producer cells, including:
- CHO or 293T cells
- Human induced pluripotent stem (hiPS) cells
- ES cells
We securely store your producer cells (for later use in viral vector production) in our CGCP facility in Shiga, Japan.
Clinical-grade hES cell line derivation
This service generates customer-proprietary hES cell lines for use in clinical research settings. All cell-related work is performed at GMP manufacturing sites under conditions consistent with European and US standards by specially trained personnel and according to standard operating procedures.
Storage management service
We securely store your MCBs and viral vectors in deep freezers or liquid nitrogen storage tanks under GMP conditions where:
- Only authorized personnel have access
- Temperature is monitored with a 24-hour alarm system
We provide quality-testing services compliant with international regulations like FDA, ICH, CFR, USP, and Japanese Pharmacopoeia (JP). These services can be included as a part of product evaluation, process tests, and stability tests necessary for product release.
We conduct stability tests using the test manufacturing sample or GMP sample at the requested storage conditions. Test items and time points are determined upon discussion.