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)

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: we require plasmid DNA (transfer plasmid, packaging plasmids) and producer cell lines (293T MCB is available from Takara Bio upon request)
• Deliverables: we will deliver 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)

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
• 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)

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