99% of personnel in biomanufacturing companies lack these 6 key consciousnesses
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- Issue Time
- Jun 26,2025
Summary
The biomanufacturing industry has put forward strict requirements for employees' professional ethics due to its high precision and compliance characteristics.
The following six consciousnesses are the professional principles that must be deeply rooted in the hearts of biomanufacturers.
1、 Quality awareness
For example, strictly adhering to the "Good Manufacturing Practice for Drugs", from material weighing, equipment cleaning to process parameter monitoring, eliminates the mentality of "similarity".
For example, a concentration deviation of 1% during the preparation process may lead to the failure of active ingredients; During aseptic filling, a fingerprint imprint may cause contamination of the entire batch of products.
2、 Safety awareness
For example, when processing gene edited materials, strict adherence to BSL-2/BSL-3 level protection measures (such as operating biosafety cabinets and waste disposal processes) is required.
For example, ethanol storage should be kept away from heat sources, and chemical resistant gloves should be worn when in contact with DMSO to avoid occupational exposure.
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3、 Compliance awareness
For example, it is strictly prohibited to forge detection data or tamper with process time (such as adjusting system time without authorization when the cell culture cycle is insufficient).
For example, the sterile operation certificate and equipment calibration certificate of the operator need to be updated regularly to prevent "overtime work".
4、 Efficiency awareness
For example, if the fermentation tank malfunctions and shuts down for more than 30 minutes, it may lead to bacterial aging, and preventive maintenance is needed to improve the overall efficiency of the equipment.
If the regeneration cycle of the purification column is compressed from 4 hours to 3 hours, single day multi batch production can be achieved through process reengineering.
5、 Innovation consciousness
For example, changing traditional batch fermentation to continuous flow process can increase monoclonal antibody production by more than 30%.
For example, using intelligent monitoring tools such as active learning MES systems and Process Analytical Technology (PAT).
6、 Team consciousness
For example, senior employees need to impart "implicit experience" to newcomers (such as the pressure fluctuation pattern for determining whether a chromatography column is blocked).
For example, when there is a batch deviation, do not shift responsibility, but jointly participate in Root Cause Analysis.
