Avirmax CMC Inc. a cGMP-licensed contract development and manufacturing organization (CDMO), implemented its newly developed Sf rhabdovirus-free cell lines (under the generic trademark of Sf-RVF) developed for producing recombinant adeno-associated viral vectors (rAAV).

As an insect cell line derived from the ovarian tissue of Spodoptera frugiperda (Sf), the Sf9 cell line in concert with recombinant baculoviruses, has been widely utilized for manufacturing biologics, including recombinant proteins, vaccines, and rAAV-based gene therapy vectors.

The Sf9 cell rAAV production system has been shown to produce high yields of rAAV products containing vector genomes. However, Sf9 cell lines persistently carries Sf rhabdovirus (Sf-RV), an enveloped, negative sense and single stranded RNA (-ssRNA) virus. Although Sf-RV is an insect-specific virus and non-infectious to mammalian and human cell lines, using a Sf-RV containing Sf9 cell line for producing biologics has potential viral safety risks that are required to be mitigated by international regulatory authorities during biopharmaceutical production.

When using serum-free suspension culture, Avirmax CMC’s Sf-RVF cell lines have been shown to be comparable with respect to rAAV yields and quality, relative to rAAV produced using Sf-RV parental cell lines.

“By implementing our Sf-RVF cell lines, the Sf-RV safety margin of biologic product has been increased by more than 1 billion-fold”, said Shengjiang Shawn Liu, chief executive and scientific officer of the company.

Avirmax CMC Inc. is now using the Sf-RVF cell lines in rAAV manufacturing for research and clinical development purposes. Avirmax CMC Inc. is also expanding the Sf-RVF cell lines to the production of other modalities including vaccines and protein drugs.