Four Factors Affecting Cell Factory Quality

The growth of cells has very strict requirements on the environment, temperature, pH value, etc., and the quality of cell consumables used in culturing cells will also affect the growth of cells. Cell factories are commonly used consumables for adherent cell culture, and there are four main factors that affect their quality.

1. Production raw materials: High-quality raw materials are the basis of high-quality products. The raw materials of the cell factory are polystyrene (PS) and must meet the requirements of USP Class VI. The word requirements are to test plastic materials in the medical field and pipeline products in biopharmaceuticals. The more stringent tests used in the field are non-clinical laboratory studies that comply with various experimental specifications.

2. Production environment: cells are particularly sensitive to the growth environment, so consumables are required to contain no substances harmful to cells such as endotoxin, which puts forward higher requirements for their production environment. The consumables must be produced in a dedicated 10,000-class clean room, and undergo rigorous verification (plankton, sedimentation, and suspended particle detection), and carry out quality management in accordance with GMP workshops to ensure the stability of the production environment.

3. Production process control: This refers to the inclusion of all aspects of the product in the production process, such as injection molding parameters, injection temperature, etc., which will affect the quality of the finished product.

4. Quality inspection: Quality inspection is an important process after the production of the cell factory. The items that need to be inspected include sealing, biological safety, physical and chemical safety, product validity period verification, surface hydrophilicity, etc., through these inspections to determine the product meet quality standards.

The factors that affect the quality of cell factories mainly include the above four aspects. Only by controlling these factors can high-quality products be produced, thereby providing a good environment for cell growth.