Jiachang Biological - biotechnology services and research and development as one of the high-tech enterprises
High qualityefficienttransparent
High quality, efficient and transparent
1、简介
Using engineered cells for product production ensures that each batch of product originates from a well-identified common source. Therefore, establishing a cell bank to guarantee the sustainability of production and the stability of product quality is an essential part of the manufacturing process. Canvest Bio’s cell bank establishment service provides a controlled cell bank for the entire cultivation process, along with documentation tracking, safety, and data on the characteristics of the entire cell bank.
2、流程介绍
Process and Batch Record Determination
For each cell type requiring a cell bank, Canvest Bio collaborates with customers to develop batch records suitable for the customer's cell bank needs. This is achieved through in-depth communication between Canvest Bio's cell culture and process confirmation personnel and the customer. Similarly, Canvest Bio can also provide validation/confirmation for the cell bank cultivation process.
All raw material requirements for the cell bank establishment process are determined prior to batch record confirmation.
Quality Control Before Cell Amplification and Cultivation
Cells must undergo quality confirmation before entering GMP conditions, with a quality agreement signed based on the customer's needs. Additionally, Canvest Bio will handle the procurement and testing of the materials used in establishing the cell bank.
Cell Cultivation, Amplification, and Cryopreservation
Various types of mammalian cells and/or insect cell lines can be cultured and amplified in either adherent or suspension formats (based on cell characteristics). Canvest Bio offers a variety of culture media options, including shaking flasks, square flasks, and cell factories.
Cells are released into the culture and amplification stages, where they are expanded, aliquoted to the required density, and frozen to the agreed-upon number with the customer.
All cell bank activities are strictly segregated, and each cell bank’s work is completed in an independent room.
Testing
After storage at low temperatures, cells undergo revival viability testing. Canvest Bio can provide additional testing services that meet pharmacopeia requirements（link）.A full biological safety and cell characteristic analysis report for the cell bank will be provided.
Reports
Canvest Bio will issue a QA release report for the cell bank. If the customer requires biological safety and characteristic testing of the cell bank, corresponding test reports will be provided for regulatory filing.
Cryopreservation, Storage, and Delivery
The cell bank is cryopreserved according to a defined procedure, frozen at a controlled rate to minimize freezing-related damage.
The customer’s cell bank can also be stored long-term at Canvest Bio (in vapor phase liquid nitrogen).
The cell bank can be shipped in batches to designated locations according to the customer’s needs, with the entire shipping process ensuring vapor phase liquid nitrogen and temperature monitoring.
3、设施和环境
Canvest Bio's cell production base in Wuhan is located in the Wuhan High-Tech Development Zone, Guanggu Biotech City, Building D3-2. It has nearly 4000m² of cell production facilities meeting EU and domestic cGMP standards (GMP Appendix - Biopharmaceutical Regulations). This base includes a scalable cell and gene therapy public service platform for the production and preparation of production-grade animal cell banks and clinical-grade stem cell preparations.Additionally, it features a cell storage facility that can store over 1 million cell samples and offers free long-term backup storage for customer cells.
All production activities at Canvest Bio’s cell production base strictly adhere to cGMP quality system standards and requirements. Cells are prepared, cultured, and produced in a controlled and safe environment using advanced closed-mode systems, including a C-grade background and A-grade cell modulation workstations, to meet regulatory requirements for cell banks. Each cell bank has a complete, traceable production batch record, with all activities carried out in accordance with the batch record and supervised by on-site QA. This ensures compliance with biopharmaceutical and biological product registration submission requirements.
