Yiming Cell 'Suspension 293XS Cell Bank' completed DMF filing with the US FDA

Recently, Yiming Cell Autonomous Domestication Suspension 293XS^TM Cell Bank completed the DMF filing with the US FDA and has received a confirmation letter with the record number DMF 28844.

The 293XS^TM cell line is suitable for large-scale production of multiple AAV serotypes and has obtained an invention patent certificate issued by the State Intellectual Property Office of China. In the future, the AAV project of Yiming cell customers can directly refer to the corresponding DMF filing number when applying for IND, which greatly shortens the product review and evaluation time, simplifies the IND application package, and accelerates the project application process of related drugs.

Yiming Cell Suspension 293XS^TM Cell Bank DMF Filing Confirmation Letter

Image source: Yiming Cell Guanwei

In the AAV production platform based on the "triplasmid transicitation method", scalable, stable cell lines are one of the core components. 293XS^TM cell bank of Yiming cells:

• High density, culture density up to 1E7 cells/ml

   

• It can be scaled up to achieve 50L-200L-500L-2000L scale cell culture

   

• High yield, AAV yield can exceed 1E14VG/L

   

• Safe, no coviruses, no components of animal origin

   

• Provide perfect documentation to prove that the cell bank production meets GMP standards and fully meets the requirements of Sino-US double report

   

• Independent domestication can be authorized, and has obtained the invention patent certificate issued by the State Intellectual Property Office of China

   

• Completed DMF filing with the U.S. FDA, greatly reducing product review and evaluation time

   

• In 2022, the three AAV gene drugs manufactured by Yiming Cell and approved for IND all used the 293XS^TM cell line*

Part of the data of 293XS^TM (data from Yiming cells)|A: 200LAAV production system, 3 batches of cell total and viability comparison data; B: 200L bioreactor fermentation curve; C: Wave 25LAAV production system, the total number of cells in 3 batches and the viability data were compared; D: 200L AAV production system, after the first step of affinity chromatography capture, the empty shell rate is only 56%.

*: The three approved NMPA IND AAV projects with Yiming Cell are "VGR-R01" and "VGB-R04" of Tianze Yuntai and "LX101" of Langsheng Biologics.

At present, Yiming cells have completed the DMF filing with the US FDA for three self-developed varieties, as shown in the following table:

DMF refers to the drug file file submitted to FDA by the raw material supplier, which contains confidential details such as facilities, operating procedures, and raw materials used in the production, operation, packaging, and storage of the drug product. According to the US Federal Food, Drug and Cosmetic Act, drugs must submit relevant applications (such as clinical research applications (INDs), new drug registration (NDAs) and biological product license applications (BLAs)) to the FDA before marketing, and need to provide all information on the safety, efficacy and quality of the drug, which also involves APIs and excipients and other related technical content. This information is not only cumbersome and complex, but also involves confidentiality requirements. The DMF (Durg Master Files) system was born in response to the demand.

Yiming Cell files the above information with the FDA in the form of DMF files and obtains the DMF filing number of the corresponding product, which saves the approval cost, improves the approval efficiency and shortens the registration cycle for Yiming Cell customers in the declaration of lentiviral and AAV vector projects.