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Four Factors Affecting Cell Factory Quality

Wed Apr 20 10:42:14 CST 2022

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.

The FAI climbed 5.9 percent year-on-year in the first 11 months of 2018, quickening from the 5.7-percent growth in Jan-Oct, the National Bureau of Statistics (NBS) said Friday in an online statement.

The key indicator of investment, dubbed a major growth driver, hit the bottom in August and has since started to rebound steadily.

In the face of emerging economic challenges home and abroad, China has stepped up efforts to stabilize investment, in particular rolling out measures to motivate private investors and channel funds into infrastructure.

Friday's data showed private investment, accounting for more than 60 percent of the total FAI, expanded by a brisk 8.7 percent.

NBS spokesperson Mao Shengyong said funds into weak economic links registered rapid increases as investment in environmental protection and agriculture jumped 42 percent and 12.5 percent respectively, much faster than the average.

In breakdown, investment in high-tech and equipment manufacturing remained vigorous with 16.1-percent and 11.6-percent increases respectively in the first 11 months. Infrastructure investment gained 3.7 percent, staying flat. Investment in property development rose 9.7 percent, also unchanged.