The invention belongs to the technical field of polypeptide drugs, and discloses a low-temperature
crystallization process early warning method and
system based on digital twin polypeptide drugs, and the method comprises the steps: obtaining batch information of polypeptide drugs, and
crystallization process data and online spectrum data during a low-temperature
crystallization process, inputting batch information and crystallization process data into a digital twinborn model, predicting to obtain state parameters in a low-temperature crystallization process, extracting feature vectors related to the crystallization process from online
spectral data to obtain real-time spectral features, calculating the inconsistency degree between the key state parameters and the real-time spectral features, and calculating the inconsistency degree between the key state parameters and the real-time spectral features. A prediction deviation
evaluation result is obtained, and when it is detected that the prediction deviation
evaluation result is larger than a preset evaluation threshold value or the real-time spectral features are abnormal data, an early warning
signal is sent out; when it is detected that the prediction deviation
evaluation result is larger than the preset evaluation threshold value or the real-time spectral characteristics are abnormal data, the early warning
signal is sent out, and the early warning efficiency in the low-temperature crystallization process is improved.