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.

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)

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)

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)

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.