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Takara Bio granted manufacturing license for clinical-grade hES cell line derivation

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Home › Services & Support › Gene and cell therapy manufacturing › Facilities

Gene and cell therapy manufacturing

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T-cell processing Services
Gloved hand holding a small bottle Our process
Takara Bio granted manufacturing license for clinical-grade hES cell line derivation

Submit a CMO service inquiry

Custom services

Facilities

Our premier facilities are a cornerstone of Takara Bio's promise to deliver the highest-quality products and impeccable services. Our facilities include: 

  • Center for Gene and Cell Processing (CGCP)—an award-winning manufacturing facility for gene and cell therapy products
  • Center for Gene and Cell Processing - Life Innovation Center (CGCP-LIC)—our cell processing facility
  • hES Cell Banks—a specialized facility for the manufacture of human embryonic stem cell line derivation and banking

Center for Gene and Cell Processing (CGCP)

Our core manufacturing facility, the CGCP located in Kusatsu, Shiga, was designed specifically for the safe and efficient manufacture of gene and cell therapy products. In 2016, the International Society for Pharmaceutical Engineering selected Takara Bio’s CGCP as the winner of its Facility of the Year Award (in the facility integration category). Its unique environment ensures product safety and was determined by the judges to be a practical, efficient model for future biopharmaceutical facilities.

Meets major GMP regulations

The CGCP was designed to meet major regulations like cGMP, PIC/s GMP, and EU GMP. It has received accreditation as a “foreign cell processor” to conduct specific processed-cell manufacturing. It has also received ISO 9001 certification.

One-stop manufacturing facility

The CGCP's innovative use of facility integration allows for the production of cell products, viral vectors, and recombinant proteins within the same facility. Each area has an independent airflow pipeline, material flow, VHP (vaporized hydrogen system) for decontamination, and personnel team. They are also equipped with independent QC laboratories and dedicated facilities for cell banking. Since the independent processing areas are all under one roof, the CGCP can operate with high efficiency and zero contamination, so you can depend on the products produced and services performed on-site.

Designed for efficiency, purity, and high-quality production

  • Multiple manufacturing rooms enable the parallel manufacture of multiple items
  • Warehouse, storage rooms, and testing areas are configured for efficiency
  • Air locks, one-way passage systems, independent ventilation systems, and separated flow for operations and materials minimize the risk of contamination

CGCP facility, Japan

 


Center for Gene and Cell Processing - Life Innovation Center (CGCP-LIC)

The CGCP-LIC is a facility dedicated to cell processing, situated in Kawasaki, Kanagawa near the Tokyo International Airport. The CGCP-LIC facility enables rapid transport within Japan and to other Asian countries.

East Japan facility


hES Cell Banks

Takara Bio Europe AB operates a specialized facility in Göteborg, Sweden, for the manufacture of human embryonic stem (hES) cell banks according to guidelines for Good Manufacturing Practices. In 2018, the facility was granted a manufacturing license by the Medical Products Agency (the Swedish national authority) for clinical-grade human embryonic stem cell line derivation and banking.

Takara Bio Europe facility height=


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Takara Bio USA, Inc. provides kits, reagents, instruments, and services that help researchers explore questions about gene discovery, regulation, and function. As a member of the Takara Bio Group, TBUSA is part of a company that holds a leadership position in the global market and is committed to improving the human condition through biotechnology. Our mission is to develop high-quality innovative tools and services to accelerate discovery.

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Takara Bio USA, Inc. provides kits, reagents, instruments, and services that help researchers explore questions about gene discovery, regulation, and function. As a member of the Takara Bio Group, TBUSA is part of a company that holds a leadership position in the global market and is committed to improving the human condition through biotechnology. Our mission is to develop high-quality innovative tools and services to accelerate discovery.

FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES (EXCEPT AS SPECIFICALLY NOTED).

Clontech, TaKaRa, cellartis

  • Products
  • COVID-19 research
  • Next-generation sequencing
  • Diagnostic solutions
  • Real-time PCR
  • Stem cell research
  • mRNA and cDNA synthesis
  • PCR
  • Cloning
  • Nucleic acid purification
  • Gene function
  • Protein research
  • Antibodies and ELISA
  • New products
  • Special offers
  • COVID-19 research
  • Viral detection with qPCR
  • SARS-CoV-2 pseudovirus
  • Human ACE2 stable cell line
  • Viral RNA isolation
  • Viral and host sequencing
  • Vaccine development
  • CRISPR screening
  • Drug discovery
  • Immune profiling
  • Publications
  • Next-generation sequencing
  • RNA-seq
  • DNA-seq
  • Single-cell NGS automation
  • Reproductive health
  • Bioinformatics tools
  • Whole genome amplification
  • Immune profiling
  • Diagnostic solutions
  • Reproductive health
  • Real-time PCR
  • Real-time PCR kits
  • Reverse transcription prior to qPCR
  • High-throughput qPCR solutions
  • RNA extraction and analysis for real-time qPCR
  • Stem cell research
  • Media and supplements
  • Stem cells and stem cell-derived cells
  • Single-cell cloning of edited hiPS cells
  • mRNA and cDNA synthesis
  • In vitro transcription
  • cDNA synthesis kits
  • Reverse transcriptases
  • RACE kits
  • Purified cDNA & genomic DNA
  • Purified total RNA and mRNA
  • PCR
  • Most popular polymerases
  • High-yield PCR
  • High-fidelity PCR
  • GC rich PCR
  • PCR master mixes
  • Cloning
  • In-Fusion seamless cloning
  • Competent cells
  • Ligation kits
  • Restriction enzymes
  • Nucleic acid purification
  • Plasmid purification kits
  • Genomic DNA purification kits
  • DNA cleanup kits
  • RNA purification kits
  • Cell-free DNA purification kits
  • Microbiome
  • Gene function
  • Gene editing
  • Viral transduction
  • Fluorescent proteins
  • T-cell transduction and culture
  • Tet-inducible expression systems
  • Transfection reagents
  • Cell biology assays
  • Protein research
  • Purification products
  • Two-hybrid and one-hybrid systems
  • Mass spectrometry reagents
  • Antibodies and ELISA
  • Primary antibodies and ELISAs by research area
  • Fluorescent protein antibodies
  • Special offers
  • Try BcaBEST DNA Polymerase ver.2.0
  • RNA purification sale
  • Capturem IP and Co-IP sale
  • Baculovirus titration kits early access program
  • NGS bundle and save
  • Free sample: PrimePath Direct Saliva SARS-CoV-2 Detection Kit
  • TALON his-tag purification resin special offer
  • GoStix Plus special offers
  • PCR samples
  • Services & Support
  • Instrument services
  • OEM & custom enzyme manufacturing
  • Stem cell services
  • Gene and cell therapy manufacturing
  • Customer service
  • Sales
  • Shipping & delivery
  • Technical support
  • Feedback
  • Online tools
  • Partnering & Licensing
  • Vector information
  • Instrument services
  • Apollo services
  • ICELL8 services
  • SmartChip services
  • OEM & custom enzyme manufacturing
  • Services
  • Quality
  • Expertise
  • OEM enzyme FAQs
  • Custom enzyme samples
  • Exploring OEM and custom enzyme partnerships
  • Stem cell services
  • Clinical-grade stem cell services
  • Research-grade stem cell services
  • Outsourcing stem cell-based disease model development
  • Gene and cell therapy manufacturing
  • Services
  • Facilities
  • Our process
  • Resources
  • Sales
  • Make an appointment with your sales rep
  • Online tools
  • GoStix Plus FAQs
  • Vector information
  • Vector document overview
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  • Automation systems
  • Next-generation sequencing
  • cDNA synthesis
  • Real-time PCR
  • Nucleic acid purification
  • PCR
  • Cloning
  • Stem cell research
  • Gene function
  • Protein research
  • Antibodies and ELISA
  • Automation systems
  • SmartChip Real-Time PCR System introduction
  • ICELL8 introduction
  • Next-generation sequencing
  • Technical notes
  • Featured kits
  • Technology and application overviews
  • FAQs and tips
  • DNA-seq protocols
  • Bioinformatics resources
  • Webinars
  • Real-time PCR
  • Overview
  • Reaction size guidelines
  • Guest webinar: extraction-free SARS-CoV-2 detection
  • Guest webinar: developing and validating molecular diagnostic tests
  • Technical notes
  • Nucleic acid purification
  • Nucleic acid extraction webinars
  • Product demonstration videos
  • Product finder
  • Plasmid kit selection guide
  • RNA purification kit finder
  • PCR
  • Citations
  • Selection guides
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  • FAQ
  • Cloning
  • In-Fusion Cloning general information
  • Primer design and other tools
  • In‑Fusion Cloning tips and FAQs
  • Applications and technical notes
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  • Overview
  • Protocols
  • Technical notes
  • Gene function
  • Gene editing
  • Viral transduction
  • T-cell transduction and culture
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  • Applications
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  • Partnering
  • Webinar: Speeding up diagnostic development
  • Contact us
  • Vaccine development
  • Characterizing the viral genome and host response
  • Identifying and cloning vaccine targets
  • Expressing and purifying vaccine targets
  • Immunizing mice and optimizing vaccine targets
  • Pathogen detection
  • Sample prep
  • Detection methods
  • Identification and characterization
  • SARS-CoV-2
  • Antibiotic-resistant bacteria
  • Food crop pathogens
  • Waterborne disease outbreaks
  • Viral-induced cancer
  • Immunotherapy research
  • T-cell therapy
  • Antibody therapeutics
  • T-cell receptor profiling
  • TBI initiatives in cancer therapy
  • Cancer research
  • Sample prep from FFPE tissue
  • Sample prep from plasma
  • Cancer biomarker discovery
  • Cancer biomarker quantification
  • Single cancer cell analysis
  • Cancer genomics and epigenomics
  • HLA typing in cancer
  • Gene editing for cancer therapy/drug discovery
  • Alzheimer's disease research
  • Antibody engineering
  • Sample prep from FFPE tissue
  • Single-cell sequencing
  • Reproductive health technologies
  • Preimplantation genetic testing
  • ESM Collection Kit forms
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