
AAV Manufacturing
Adeno-Associated Viral Vectors, or AAVs, are used to deliver small genetic material packages. They are safe and efficient for in vivo treatment. AAVs are non-integrating, meaning the genetic materials they carry aren’t injected into the cell’s genome. Therefore, they are a preferred method for non-dividing target cells.
Upstream production platforms
With exclusive and customizable upstream platforms based on high producing 293T cell lines, TFBS Bioscience has developed an optimized adherent/suspension culture transfection methods for AAV production ( normal production >1E+14 GC/L)
Downstream purification platforms
We provide services, such as iodixanol gradient ultracentrifugation and chromatography purification, based on the preferences, product performance, and project development needs of our clients. Our team of specialists are experts in operating controlled processes in order to deliver optimal yield and purity of products to our clients.
QC Testing
Adeno-Associated Viral Vectors QC testing assay development
Attributes of virus | Characteristics | Methodology | Research grade | High-quality | cGMP grade |
---|---|---|---|---|---|
Identity | Apperarance | Visual inspection | ○ | ● | ● |
pH | pH Meter | ○ | ● | ● | |
Osmolality | Osmometry | ○ | ● | ● | |
Genetic composition/ integrity | NGS/DNA sequencing | ○ | ● | ||
Purity | Residual host cell proteins | ELISA | ○ | ● | |
Residual bovine plasma proteins | ELISA | ○ | ● | ||
Residual host cell DNA | q-PCR | ○ | ● | ||
Residual DNA size | DNA gel electrophoresis | ○ | ● | ||
Empty:full particles ratio | TEM | ○ | ● | ||
Residual plasmid DNA | q-PCR | ○ | ● | ||
Process derived impurities | Depends | ○ | ● | ||
Quantity | Viral genomes titer | q-PCR | ● | ● | ● |
AAV infectivity titer | Cell-based q-PCR | ○ | ● | ● | |
AAV capsid titer | ELISA | ○ | ● | ● | |
Safety | Endotoxin | Kinetic Chromogent LAL assay | ○ | ● | ● |
Sterility | 21 CFR | ● | ● | ● | |
Mycoplasma | 21 CFR or NAT | ● | ● | ● | |
Replication-competent virus (RCV) | Cell-based q-PCR or PERT | ○ | ● | ||
Testing for adventitious viruses | In vitro or in vivo test | ○ | ● | ||
Potency | Potency | Customized Bioassay Method: Cell-based or Virus-based assay | ○ | ● | ● |