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Gene and cell therapy manufacturing

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Custom services

Gene and cell therapy manufacturing services

Your work is extremely important to us, and you can rest assured that we will treat your project as if it is our own. We support your gene and cell therapy projects from development to manufacturing by providing services for plasmid vector and mRNA production, viral vector production, cell processing, cell banking, and quality testing.

Services  

Plasmid production

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

mRNA production

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

Virus icon Viral vector production

We offer research-grade and GMP-grade viral vector production services for:

  • Retrovirus (Master Cell Bank, Working Cell Bank)
  • Lentivirus
  • Adeno- and adeno-associated viruses

Cell processing

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

Cell banking

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.

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

Quality testing

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.

Stability testing

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.

Transportation testing

We conduct transportation tests from our facility to clinical trial facilities.

Workflow  

Process development

  • Process optimization
  • Scale-up studies
  • Nonclinical batch manufacturing
  • Safety and quality testing/development
  • Learn more

Preclinical studies (subcontract)

  • Pharmacological testing
  • Pharmacokinetic testing
  • Toxicity testing
  • Tumorigenicity testing

Investigational manufacturing

  • Viral vector production
  • Cell banking
  • Genetically modified cell manufacturing
  • Cell processing
  • Investigational drug storage and delivery
  • Safety, quality, and stability testing

On market

Process development  

 

Initial consultation

Under a confidentiality agreement, your project manager will develop a manufacturing plan based on your samples, preferred manufacturing methods and formulations, and stability specifications.

 

Manufacture pilot lot

We will perform small-scale and scale-up manufacturing tests using raw materials and manufacturing methods suitable for investigational drugs.

 

Develop safety and quality tests

We will create safety and quality tests based on your requirements using the pilot lots created for your initial custom formulation.

 

Transfer and scale-up manufacturing (non-GMP)

We will transfer the manufacturing process to our GMP facility and manufacture non-GMP grade material at quarter to full scale.

 

Specification and characteristic testing

The test manufacturing samples created during transfer and scale-up are used for nonclinical tests and for safety/quality test validation.

 

Stability and transportation testing

The test manufacturing samples are also used to perform stability tests under your desired storage conditions. Transport tests can be performed upon request.

Getting started  

We are happy to answer any questions you may have about our custom services. When you are ready to start the process, please submit an inquiry using the form on the left. If you are on a mobile device, click on the hamburger icon () on the top left of your screen, then scroll down to access the form.

We will contact you to discuss your request and will provide you with a proposal based upon your specific needs. If our proposal is acceptable to you, we will proceed with a manufacturing and supply agreement (MSA) and a quality agreement (if necessary). We are happy to accept on-site audits upon concluding the quality agreement.

Takara Bio USA, Inc.
United States/Canada: +1.800.662.2566 • Asia Pacific: +1.650.919.7300 • Europe: +33.(0)1.3904.6880 • Japan: +81.(0)77.565.6999
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