About AAV

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