Custom services

Cell processing

Gene and cell therapy manufacturing services

We offer a variety of cell processing services that leverage the expertise we have built while developing our own engineered T-cell receptor (TCR) and chimeric antigen receptor (CAR) therapies, which are currently in clinical development at Takara Bio Inc. Our proprietary expertise includes abundant experience with closed culture systems and techniques to efficiently transduce target genes using our gold-standard transduction enhancer, RetroNectin reagent.

Our cell processing services provide you with gene and cell therapy products as well as expert support in entering the clinical market in Japan and other Asian countries. Our highly skilled team has a wealth of experience in cell culture techniques and technologies such as operational scale-up to large-volume cell culture bags. We are experts in handling:

  • T cells
  • NK cells
  • Mesenchymal stem cells

We are also experienced with gene transduction using various types of viral vectors, especially retroviral and lentiviral vectors. We can accommodate your choice of transduction method, including closed-system culture bags or automated cell culture systems. We also offer the option to reserve an exclusive suite for your project; please describe the desired conditions in your initial inquiry.

Cell processing workflow

Blood samples are collected from patients at hospitals and clinics, and these samples are sent to the Center for Gene and Cell Processing (CGCP). The collected blood is then concentrated, cultured, and transduced using vectors produced at the same CGCP facility. The clonal cell lines are then expanded and sent back to the treatment centers.

Cell processing workflow


Case study: retroviral vector transduction of a cell line
Workflow for retroviral vector transductionTimeline (months; varies with project scope)
3 6 9 12 15 18 21 24 27 30 33 36
Manufacturing virus producer cells
Manufacturing and quality testing of Producer Cell Bank
First-lot viral vector production and quality testing
Process development and evaluation of the transduced cell line
Pilot-lot test manufacturing of the transduced cell line (non-GMP)
First-lot manufacturing of the transduced cell line; quality and stability testing
Nonclinical studies
Second-lot manufacturing of the viral vector; quality testing
Second-lot manufacturing of the transduced cell line; quality testing

NOTE: The workflow and timing may vary depending on your project's target gene, process development, production scale, and required number of lots. We can support your entire workflow, from vector construction to process development, investigational drug manufacturing, and regulatory support. For more information on our T-cell processing services, please submit an inquiry.

Standard tests* for CAR-T cells
Verification tests Infectious factor verification tests Characteristic analysis
  • Appearance test
  • Cell concentration
  • Cell viability
  • Target gene copy number
  • Vector integrity test (PCR)
  • LAM-PCR
  • Sterility
  • Mycoplasma
  • Endotoxin
  • Replication-competent virus
  • In vitro virus testing
  • GaLV RCR testing
  • IL-2 dependent proliferative study
  • Immunity phenotype
  • CAR expression
  • Cytotoxic activity

*Not including virus quality testing

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