3 results about "Process validation" patented technology

The present disclosure provides methods and systems for preparing and using contrived nucleic acid samples for process validation and control. The contrived nucleic acid samples have prescribed specific physical and chemical characteristics, and are present in quantities sufficient to validate and confirm large-scale sequencing processes. Method validation may require known samples to confirm expected outcomes of the processes being validated. The inherent biological variability of biological samples obtained from individuals may not be suitable for the rigid requirements of process validation. The contrived biological samples described herein may approximate the complexity and biological features of a biological sample in a known and defined manner that may be controlled accordingly for the processes being validated.

This invention belongs to the field of biodetection technology, specifically relating to a highly sensitive and specific quantitative detection method for total RNA of Escherichia coli remaining during the production of biological products (such as recombinant proteins, vaccines, cell therapy products, etc.). In particular, it relates to the construction of a detection system based on reverse transcription real-time quantitative polymerase chain reaction (RT-qPCR) technology, primer and probe design, and standardized operating procedures, and further expands its application in drug quality control, process validation, and cleaning validation.

This application provides a production process management method, apparatus, electronic device, and storage medium. The method acquires a process verification standard knowledge base, information on the project to be verified, and production process data to be verified. The process verification standard knowledge base is generated based on a process document source; if the process document source changes, the process verification standard knowledge base is updated based on the changed process document source. The method verifies the production process data to be verified based on the process verification standard knowledge base and the information on the project to be verified. If the verification result is abnormal, the cause of the abnormality is determined, and then the abnormality handling object and abnormality handling rules are determined. The cause of the abnormality and the abnormality handling rules are sent to the abnormality handling object to manage the production process. By dynamically linking and updating the process verification standard knowledge base with the process document source, this method can better adapt to complex and ever-changing production scenarios, improve the efficiency and accuracy of the verification process, and enhance the real-time performance of the verification.