Genevoyager can provide stable and traceable cell bank/virulence library construction services that meet the requirements of the filing regulations. We can also perform continuous pass-through stability studies and long-term storage stability studies to ensure that starting materials meet the requirements for drug declaration, process development and large-scale AAV preparation. All cell/virulence libraries are tested according to the requirements of the Chinese Pharmacopoeia to ensure quality and stability.

(1) Cell Banking Service：

Cell type：AAV-293，AAV-Sf9

Seed cell source：Purchased on behalf of the customer or purchased by the customer (it is recommended that the customer provide an authorized cell line purchased from a regular source for library construction).

Master cell bank（MCB）：After the seed cells are passaged and proliferated in the prescribed way, they are mixed into a batch uniformly at a specific multiplication level or passaged level, quantitatively dispensed into a certain number of ampoules or suitable cell lyophilization tubes, stored in liquid nitrogen or below -130°C, and then used as a master cell bank for the preparation of working cell banks after a comprehensive check.

Working cell bank（WCB）：The cells in the working cell bank are made from MCB cells by passaging and expansion. The cells from MCB are multiplied by passages to reach a certain generation level, and then combined to make a batch of homogeneous cell suspension, quantitatively dispensed into a certain number of ampoules or suitable cell lyophilization tubes, stored in liquid nitrogen or below -130°C for backup, which is the working cell bank for the production of specific AAV viruses.

(2) Virus Seed Banking Service:

Virus type: baculovirus

Primary virus bank（PVB）：Construction of seed strains for AAV production in Sf9 cells using regular source baculoviruses for the establishment of a primary virulent seed bank.

Master virus bank（MVB）：The samples of the primary virulent seed bank are passed and multiplied in the prescribed way, and after being fully checked and qualified, they can be used as the master seed virus bank. The master seed virus bank is used for the preparation of subsequent working virus seed banks.

Working virus bank（WVB）：The working virus library is made by amplifying MVB viruses after passaging for mass production of specific AAV viruses.

Identification test, virus titer, exogenous contamination factor check (sterile, mycobacterium, mycoplasma, exogenous viral factor check), determination of major functional genes and genetic markers, immunogenicity check, animal neurotoxicity test, animal tissue pathogenicity or infection test, whole gene sequence determination, etc.