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) |
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Quality testing for MCB (GMP) |
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Process development/AAV test batch (non-GMP) |
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Evaluation by customer |
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AAV test batch (non-GMP) |
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AAV manufacturing (GMP) |
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Quality testing for AAV (GMP) |
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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 |
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Endotoxin |
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Replication-competent AAV |
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