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Home › Services & Support › Gene and cell therapy manufacturing › Services › Clinical-grade viral vector production

Gene and cell therapy manufacturing

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Clinical-grade viral vector production

Gene and cell therapy manufacturing services

We have over 10 years of experience in viral vector production and a track record of over 100 virus and cell-bank production projects that were manufactured and tested in accordance with GMP guidelines.

Overview Adeno-associated virus Lentivirus Retrovirus

Overview  

We offer virus production services for adeno-associated viral (AAV), lentiviral, and retroviral vectors. Other viral vectors are also available upon technical transfer.

Watch the video below to learn all about our small- and large-scale viral vector manufacturing workflows.

Our one-stop GMP manufacturing facility can support a wide range of manufacturing needs, from small-scale prototype manufacturing in the early stages of development to large-scale manufacturing up to 2,000 L. We recommend that you start with small-scale manufacturing in order to assess our manufacturing capability and to make any needed adjustments. We can accommodate special requests regarding culture vessels or containers (such as vials or bags) for the final product.

Overview of the viral vector manufacturing workflow.

Adeno-associated virus  

AAV vectors can transduce into proliferating cells and impart long-term expression. Furthermore, AAV vectors have very low immunogenicity. For these reasons, interest in the use of AAV vectors in gene therapy is rapidly growing. As each serotype shows different characteristics and tissue specificity, AAV vectors are expected to transduce target genes efficiently into heart, liver, muscle, retina, and central nervous system tissues.

  • Project initiation: we require plasmid DNA (transfer plasmid, packaging plasmids) and a producer cell line.
    NEW! Takara Bio now provides gene therapy vector CereAAV™, which is an AAV2-based serotype with enhanced brain tropism through genetic engineering and proprietary screening technology. Studies show CereAAV has a gene transfer efficiency 50 times higher in mice and 20 times higher in primate models (e.g. marmosets) than AAV9.
  • Deliverables: we will deliver AAV vector, manufacturing report, and certificate of analysis.
AAV vector productionTime (months; varies with project scope)
Workflow 2 4 6 8 10 12 14 16 18 20 22 24
MCB manufacturing (GMP)
Quality testing for MCB (GMP)
Process development/AAV test batch (non-GMP)
Evaluation by customer
AAV test batch (non-GMP)
AAV manufacturing (GMP)
Quality testing for AAV (GMP)

Examples of standard QC tests for an AAV vector
Quantitative/functional tests Purity tests Safety tests
Gene expression Host cell protein Sterility
Vector sequence Host cell DNA Mycoplasma
Viral titer (qPCR or ddPCR) Endotoxin
Replication-competent AAV

Lentivirus  

Lentiviral vectors can transduce both replicating and nonreplicating cells. They are generally produced at titers that are higher than retrovirus, and they integrate into the host genome, allowing stable, long-term expression of the transgene. Furthermore, lentiviral vectors elicit a relatively low immune response, making them a popular choice for gene therapy applications.

  • Project initiation: both plasmid DNA (transfer plasmid, packaging plasmids) and a producer cell line (293T MCB is available from Takara Bio upon request) are required for initiating the project. Takara Bio can provide LVpro Packaging Mix with various pLVpro series vectors. Please contact us if you require a lentivirus plasmid vector suitable for clinical use. 
  • Deliverables: we will deliver a lentiviral vector, a manufacturing report, and a certificate of analysis.
Lentiviral vector productionTime (months; varies with project scope)
Workflow 2 4 6 8 10 12 14 16 18 20 22 24
Manufacturing of MCB (GMP)
Quality testing for MCB (GMP)
Process development/lentiviral vector small-scale test batch (non-GMP)
Evaluation by customer
Lentiviral vector test batch (non-GMP)
Lentiviral vector manufacturing (GMP)
Quality testing for lentiviral vector (GMP)

Examples of standard QC tests for a lentiviral vector
Quantitative/functional tests Purity tests Safety tests
Gene expression Host cell protein Sterility
Vector sequence Host cell DNA Mycoplasma
Viral titer Endotoxin
Replication-competent lentivirus

Retrovirus  

Retroviral vectors transduce a wide range of hard-to-infect dividing cells and integrate into the host genome, which makes them ideal for long-term, stable expression of your transgene.

  • Project initiation: we require plasmid DNA and a packaging cell line (PG13 packaging cell line is available from Takara Bio upon request)
  • Deliverables: we will deliver a Master Cell Bank (MCB), a retroviral vector, a manufacturing report, and a certificate of analysis
Establishment of producer cloneTime (months)
Workflow 2 4 6
Plasmid acceptance
Producer cell pool generation and evaluation
Screening of producer cell clone candidates and establishment

Retroviral vector productionTime (months; varies with project scope)
Workflow 2 4 6 8 10 12 14 16 18 20 22 24 26
Manufacturing of MCB (GMP)
Quality testing for MCB (GMP)
Process development/retroviral vector small-scale test batch (non-GMP)
Evaluation by customer
Retroviral vector test batch (non-GMP)
Retroviral vector manufacturing (GMP)
Quality testing for retroviral vector (GMP)
Examples of standard QC tests for a retroviral vector
Quantitative/functional tests Safety tests
Gene expression Sterility
Vector sequence Mycoplasma
Viral titer Endotoxin
Replication-competent retrovirus
In vitro virus testing

Please submit inquiries 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.

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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, Takara Bio USA 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, Takara Bio USA 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).

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  • Products
  • COVID-19 research
  • Next-generation sequencing
  • 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
  • Spatial omics
  • RNA-seq
  • DNA-seq
  • Single-cell NGS automation
  • Reproductive health
  • Bioinformatics tools
  • Immune profiling
  • Real-time PCR
  • Great value master mixes
  • Signature enzymes
  • High-throughput real-time PCR solutions
  • Detection assays
  • References, standards, and buffers
  • Stem cell research
  • Media, differentiation kits, and matrices
  • Stem cells and stem cell-derived 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
  • Automated platforms
  • Plasmid purification kits
  • Genomic DNA purification kits
  • DNA cleanup kits
  • RNA purification kits
  • 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
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  • Antibodies and ELISA
  • Automation systems
  • Shasta Single Cell System introduction
  • SmartChip Real-Time PCR System introduction
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  • Next-generation sequencing
  • RNA-seq
  • Technical notes
  • Technology and application overviews
  • FAQs and tips
  • DNA-seq protocols
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  • Webinars
  • Real-time PCR
  • Download qPCR resources
  • Overview
  • Reaction size guidelines
  • Guest webinar: extraction-free SARS-CoV-2 detection
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  • T-cell transduction and culture
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  • Interview: adapting to change with Takara Bio
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  • mRNA and protein therapeutics
  • Characterizing the viral genome and host response
  • Identifying and cloning protein targets
  • Expressing and purifying protein targets
  • Immunizing mice and optimizing vaccines
  • 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
  • Kickstart your cancer research with long-read sequencing
  • Sample prep from FFPE tissue
  • Sample prep from plasma
  • Cancer biomarker quantification
  • Single cancer cell analysis
  • Cancer transcriptome 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
  • Embgenix FAQs
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  • ESM partnership program
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