Biopharmaceutical automatic inspection process control system and method

Abstract

The invention relates to the technical field of automation, and discloses a biopharmacy automatic inspection process control system and method. Comprising an automatic terminal control module, a detection target sample extraction module, a target sample separation and purification module, a target sample purity analysis module, a cracked molecular mass determination module and a detection target comprehensive judgment module. The purity index of the separated and purified target sample is obtained through spectral analysis on the basis of the quality influence parameters of the separated and purified target sample, and the quality index of the separated and purified target sample is obtained through mass measurement of molecules after cracking on the basis of the quality influence parameters of the separated and purified target sample. The detection target is comprehensively judged according to the purity index and the quality index, the detection report is generated, and the accuracy and efficiency of biopharmaceutical inspection are improved.

Description

Technical Field

[0001] The present invention relates to the field of automation technology, and more particularly to an automated inspection process control system and method for biopharmaceuticals. Background Art

[0002] With the aging of the population and the increasing incidence of chronic diseases, the demand for biopharmaceutical products continues to grow, and the importance of the biopharmaceutical industry has become more prominent. It is of great significance to improve the public health level and ensure the national public health security. The biopharmaceutical process is constantly developing, and more and more drugs need to be produced using biopharmaceutical processes. The integration of automation technology and information technology provides more efficient and accurate production means for the biopharmaceutical industry.

[0003] The automated control system can monitor various parameters in the production process in real time, automatically adjust the production conditions, and ensure the stability and efficiency of the production process. By introducing an advanced automated control system, biopharmaceutical enterprises can significantly improve production efficiency, reduce the production cycle, and meet the growing market demand.

[0004] However, traditional automated inspection processes for biopharmaceuticals often involve adding solvents or directly detecting the drugs. However, the physical and chemical properties of the solvents can affect the solubility and stability of the drugs, thereby affecting the test results. During the detection process, the solvents may not be completely removed, resulting in residual solvents in the drugs. On the other hand, directly detecting the drugs causes the drugs to degrade or deteriorate during the detection process, affecting the accuracy of the test results. Summary of the Invention

[0005] In order to overcome the above-mentioned defects of the prior art, the present invention provides an automated inspection process control system for biopharmaceuticals to solve the problems existing in the above-mentioned background art.

[0006] The present invention provides the following technical solution: An automated inspection process control system for biopharmaceuticals, comprising: an automated terminal control module, a detection target sample extraction module, a target sample separation and purification module, a target sample purity analysis module, a molecular weight determination module after lysis, and a detection target comprehensive judgment module;

[0007] The automated terminal control module is used to receive the inspection instructions input by the user and control each module to perform an automated inspection process according to the inspection instructions;

[0008] The detection target sample extraction module is used to automatically extract the target sample of the target to be detected from the storage container and transmit the extracted target sample to the target sample separation and purification module;

[0009] The target sample separation and purification module is used to receive the target sample transmitted by the detection target sample extraction module, perform separation and purification operations on the received target sample using separation and purification technical equipment, and collect the quality impact parameters of the target sample after separation and purification;

[0010] The target sample purity analysis module obtains the purity index of the target sample after separation and purification through spectral analysis based on the quality impact parameters of the target sample after separation and purification, and transmits the purity index of the target sample after separation and purification to the detection target comprehensive judgment module;

[0011] The post-cleavage molecular mass determination module performs the mass determination of the post-cleavage molecules based on the quality impact parameters of the target sample after separation and purification to obtain the mass index of the target sample after separation and purification, and transmits the mass degree index of the target sample after separation and purification to the detection target comprehensive judgment module;

[0012] The detection target comprehensive judgment module is used to comprehensively judge the detection target based on the purity index and the mass index, generate a detection report, and feedback the detection report to the automatic terminal control module.

[0013] Preferably, in the automatic terminal control module, there are a user instruction receiving unit and an inspection report receiving unit. The user instruction receiving unit is used to receive the inspection instructions input by the user and control each module to perform an automatic inspection process according to the inspection instructions. The inspection report receiving unit is used to receive the inspection report transmitted by the detection target comprehensive judgment module and transmit the detection target to the qualified inspection area and the unqualified inspection area respectively according to the inspection report.

[0014] Preferably, in the detection target sample extraction module, there are a high-precision robotic arm and an intelligent recognition system for identifying and extracting the detection target sample.

[0015] Preferably, in the target sample separation and purification module, a high-performance liquid chromatograph is used to perform separation and purification operations on the target sample, and a high-precision mass monitoring instrument is used to monitor in real time the quality impact parameters of the target sample after separation and purification. The quality impact parameters include the target sample purity parameter and the post-cleavage molecular mass parameter of the target sample;

[0016] The specific content for obtaining the target sample purity parameter is: performing near-infrared spectral interference on the target sample after separation and purification. When the vibration frequency of the infrared spectrum meets the preset standard, the near-infrared spectral interference operation is completed, and the target sample purity parameter is obtained. The target sample purity parameter includes: the photon energy when the near-infrared spectral interference operation is completed, the light source intensity when the near-infrared spectral interference operation is completed, and the optical path difference indicating when the near-infrared spectral interference operation is completed;

[0017] The specific content for obtaining the molecular mass parameters after the target sample is pyrolyzed is as follows: The molecular mass parameters after the target sample is pyrolyzed are measured by a mass spectrometer, and the molecular mass parameters include the number of different types of molecules and the molecular weights of different types of molecules.

[0018] Preferably, in the target sample purity analysis module, the specific content for obtaining the purity index of the separated and purified target sample through spectral analysis based on the mass influence parameters of the separated and purified target sample is as follows:

[0019] Perform near-infrared spectral interference on the separated and purified target sample, and conduct spectral analysis based on the formed photon energy to calculate the photon frequency of the target sample after spectral analysis. The calculation formula is: where v represents the photon frequency of the target sample after spectral analysis, E represents the photon energy when the near-infrared spectral interference operation is completed, and k represents Planck's constant;

[0020] Based on the photon frequency of the target sample after spectral analysis, take the optical path difference of the near-infrared spectral interference as the independent variable and input it into the near-infrared spectral interference model to calculate the interference intensity. The calculation formula is: Y(x) = U × cos(2π × v × x), where Y(x) represents the interference intensity of the near-infrared spectrum, U represents the light source intensity when the near-infrared spectral interference operation is completed, v represents the photon frequency of the target sample after spectral analysis, and x represents the optical path difference when the near-infrared spectral interference operation is completed;

[0021] Calculate the purity index of the separated and purified target sample based on the interference intensity of the near-infrared spectrum. The calculation formula is: where Sy represents the purity index of the target sample, and Y(x) represents the interference intensity of the near-infrared spectrum, represents the preset interference intensity of the near-infrared spectrum.

[0022] Preferably, in the module for measuring the mass of molecules after pyrolysis, the specific content for measuring the mass of molecules after pyrolysis based on the mass influence parameters of the separated and purified target sample to obtain the mass index of the separated and purified target sample is as follows:

[0023] Extract n types of molecules contained in the target sample after pyrolysis, where i = 1, 2, 3,..., n, and i represents the number of different molecules in the target sample after pyrolysis;

[0024] Based on the molecular masses of different molecules in the target sample after pyrolysis, calculate the mass index of the target sample. The calculation formula is: where Sx represents the mass index of the target sample, P i represents the number of the i-th type of molecule, M i represents the molecular weight of the i-th type of molecule, It represents the number-average molecular weight, and the number-average molecular weight represents the result of the weighted average of various molecular weights according to their molar numbers.

[0025] Preferably, in the detection target comprehensive judgment module, for comprehensively judging the detection target based on the purity index and the quality index and generating the specific content of the detection report as follows:

[0026] Establish a comprehensive judgment model based on the purity index and the quality index, and the expression of the model is: Where D represents the output value of the comprehensive judgment model, Sy represents the purity index of the target sample, Sx represents the quality index of the target sample, and λ1 and λ2 represent the influence coefficients of the comprehensive detection of the target sample;

[0027] Automatically inspect the detection target according to the output value of the comprehensive judgment model. If the output value of the comprehensive judgment model is greater than or equal to the preset judgment threshold, the automatic inspection is qualified; if the output value of the comprehensive judgment model is less than the preset judgment threshold, the automatic inspection is unqualified;

[0028] Generate a detection report and transmit the inspection report to the automatic terminal control module. The detection target comprehensive judgment module has the functions of automatic printing and storage, and the user queries the historical detection report through the automatic terminal control module.

[0029] A method for controlling an automatic inspection process of biopharmaceuticals includes the following steps:

[0030] Step S01: Receive the inspection instruction input by the user and control each module to perform the automatic inspection process according to the inspection instruction;

[0031] Step S02: Automatically extract the target sample of the detection target from the storage container;

[0032] Step S03: Perform separation and purification operations on the received target sample by using separation and purification technical equipment, and collect the quality influence parameters of the target sample after separation and purification;

[0033] Step S04: Obtain the purity index of the target sample after separation and purification by spectral analysis based on the quality influence parameters of the target sample after separation and purification;

[0034] Step S05: Perform mass determination of the molecules after cleavage based on the quality influence parameters of the target sample after separation and purification to obtain the quality index of the target sample after separation and purification;

[0035] Step S06: Comprehensively judge the detection target based on the purity index and the quality index, and generate a detection report.

[0036] The technical effects and advantages of the present invention:

[0037] The present invention is provided with an automated terminal control module, a detection target sample extraction module, a target sample separation and purification module, a target sample purity analysis module, a molecular mass determination module after lysis, and a detection target comprehensive judgment module. By using separation and purification technical equipment to perform separation and purification operations on the received target sample, it can initially remove impurities and ensure the activity of components, improving the accuracy and efficiency of biopharmaceutical inspection.

[0038] Based on the quality influence parameters of the target sample after separation and purification, the purity index of the target sample after separation and purification is obtained through spectral analysis. Based on the quality influence parameters of the target sample after separation and purification, the mass of the molecules after lysis is measured to obtain the mass index of the target sample after separation and purification. The detection target is comprehensively judged based on the purity index and the mass index, reducing the risk of drug degradation during detection caused by adding solvents or directly detecting drugs, and at the same time reducing the risk of drug deterioration caused by impurity interference during detection. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 It is a schematic structural diagram of a biopharmaceutical automated inspection process control system.

[0040] Figure 2 It is a schematic flow diagram of a biopharmaceutical automated inspection process control method. DETAILED DESCRIPTION OF THE INVENTION

[0041] Next, the technical solutions in the present invention will be clearly and completely described in conjunction with the drawings in the present invention. In addition, the forms of the various structures described in the following embodiments are merely examples, and a biopharmaceutical automated inspection process control system and method involved in the present invention are not limited to the various structures described in the following embodiments. All other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of the present invention.

[0042] As Figure 1 shown, the present invention provides a biopharmaceutical automated inspection process control system, including: an automated terminal control module, a detection target sample extraction module, a target sample separation and purification module, a target sample purity analysis module, a molecular mass determination module after lysis, and a detection target comprehensive judgment module;

[0043] The automated terminal control module is used to receive the inspection instructions input by the user and control each module to perform an automated inspection process according to the inspection instructions;

[0044] The detection target sample extraction module is used to automatically extract the target sample of the target to be detected from the storage container and transmit the extracted target sample to the target sample separation and purification module;

[0045] The target sample separation and purification module is used to receive the target sample transmitted by the detection target sample extraction module, perform separation and purification operations on the received target sample using separation and purification technical equipment, and collect the quality influence parameters of the target sample after separation and purification;

[0046] The target sample purity analysis module obtains the purity index of the target sample after separation and purification through spectral analysis based on the quality influence parameters of the target sample after separation and purification, and transmits the purity index of the target sample after separation and purification to the detection target comprehensive judgment module;

[0047] The molecular mass determination module after lysis determines the mass index of the molecules after lysis based on the quality influence parameters of the target sample after separation and purification, and transmits the mass degree index of the target sample after separation and purification to the detection target comprehensive judgment module;

[0048] The detection target comprehensive judgment module is used to comprehensively judge the detection target based on the purity index and the mass index, generate a detection report, and feedback the detection report to the automated terminal control module.

[0049] In this embodiment, it should be specifically noted that in the automated terminal control module, there are a user instruction receiving unit and an inspection report receiving unit. The user instruction receiving unit is used to receive the inspection instructions input by the user, and control each module to perform an automated inspection process according to the inspection instructions. The inspection report receiving unit is used to receive the inspection report transmitted by the detection target comprehensive judgment module, and transmit the detection target to the qualified inspection area and the unqualified inspection area respectively according to the inspection report.

[0050] In this embodiment, it should be specifically noted that in the detection target sample extraction module, there are a high-precision robotic arm and an intelligent recognition system, which are used to identify and extract the detection target sample. The high-precision robotic arm accurately locates and grabs the target sample in the storage container, reducing the error of manual operation, improving the accuracy and efficiency of extraction. The intelligent recognition system ensures the smooth progress of the extraction process by identifying the position information of the target sample, ensuring the integrity of the detection target. In addition, the module also has an automatic cleaning and disinfection function to ensure the hygiene and safety of the extraction process.

[0051] In this embodiment, it should be specifically noted that in the target sample separation and purification module, a high-performance liquid chromatograph is used to perform separation and purification operations on the target sample. The separation and purification operations can effectively remove impurities, making the subsequent acquisition of parameters more accurate. And a high-precision quality monitoring instrument is used to monitor the quality influence parameters of the target sample after separation and purification in real time. The quality influence parameters include the target sample purity parameter and the molecular mass parameter of the target sample after lysis;

[0052] The specific content for obtaining the purity parameter of the target sample is as follows: perform near-infrared spectral interference on the separated and purified target sample. When the vibration frequency of the infrared spectrum meets the preset standard, complete the near-infrared spectral interference operation and obtain the purity parameter of the target sample. The purity parameter of the target sample includes: the photon energy when the near-infrared spectral interference operation is completed, the light source intensity when the near-infrared spectral interference operation is completed, and the optical path difference indicating when the near-infrared spectral interference operation is completed;

[0053] The specific content for obtaining the molecular mass parameter after the target sample is lysed is as follows: determine the molecular mass parameter after the target sample is lysed by a mass spectrometer. The molecular mass parameter includes the number of different types of molecules and the molecular weight of different types of molecules.

[0054] In this embodiment, it should be specifically noted that in the target sample purity analysis module, the specific content for obtaining the purity index of the separated and purified target sample through spectral analysis based on the mass influence parameter of the separated and purified target sample is as follows:

[0055] When using near-infrared spectroscopy for measurement, it is difficult to obtain accurate quantitative analysis results from the spectral data obtained at a single wavelength. Therefore, when performing quantitative analysis, spectral data is generally obtained through multi-wavelength interference;

[0056] Perform near-infrared spectral interference on the separated and purified target sample, and perform spectral analysis based on the formed photon energy to calculate the photon frequency of the target sample after spectral analysis. The calculation formula is: where v represents the photon frequency of the target sample after spectral analysis, E represents the photon energy when the near-infrared spectral interference operation is completed, and k represents Planck's constant;

[0057] Based on the photon frequency of the target sample after spectral analysis, input the optical path difference of the near-infrared spectral interference as an independent variable into the near-infrared spectral interference model to calculate the interference intensity. The calculation formula is: Y(x) = U × cos(2π × v × x), where Y(x) represents the interference intensity of the near-infrared spectrum, U represents the light source intensity when the near-infrared spectral interference operation is completed, v represents the photon frequency of the target sample after spectral analysis, and x represents the optical path difference when the near-infrared spectral interference operation is completed;

[0058] Calculate the purity index of the separated and purified target sample based on the interference intensity of the near-infrared spectrum. The calculation formula is: where Sy represents the purity index of the target sample, and Y(x) represents the interference intensity of the near-infrared spectrum, represents the preset interference intensity of the near-infrared spectrum.

[0059] In this embodiment, it should be specifically noted that in the module for measuring the molecular weight after lysis, the specific content of measuring the molecular weight of the molecules after lysis based on the mass influence parameters of the target sample after separation and purification to obtain the mass index of the target sample after separation and purification is as follows:

[0060] Extract n kinds of molecules contained in the target sample after lysis, where i = 1, 2, 3,..., n, and i represents the number of different molecules in the target sample after lysis;

[0061] Calculate the mass index of the target sample according to the molecular weights of different molecules in the target sample after lysis. The calculation formula is: where Sx represents the mass index of the target sample, P i represents the quantity of the i-th kind of molecule, and M i represents the molecular weight of the i-th kind of molecule, represents the number-average molecular weight, and the number-average molecular weight represents the result of the weighted average of various molecular weights according to their molar amounts.

[0062] In this embodiment, it should be specifically noted that in the module for comprehensive judgment of the detection target, the specific content of comprehensively judging the detection target based on the purity index and the mass index to generate a detection report is as follows:

[0063] Establish a comprehensive judgment model based on the purity index and the mass index. The expression of the model is: where D represents the output value of the comprehensive judgment model, Sy represents the purity index of the target sample, Sx represents the mass index of the target sample, and λ1 and λ2 represent the influence coefficients of the comprehensive detection of the target sample;

[0064] Automatically inspect the detection target according to the output value of the comprehensive judgment model. If the output value of the comprehensive judgment model is greater than or equal to the preset judgment threshold, the automatic inspection is qualified; if the output value of the comprehensive judgment model is less than the preset judgment threshold, the automatic inspection is unqualified;

[0065] Generate a detection report and transmit the inspection report to the automatic terminal control module. The automatic terminal control module transmits the detection target to the qualified inspection area and the unqualified inspection area respectively according to the inspection report. The module for comprehensive judgment of the detection target has the functions of automatic printing and storage to ensure the accuracy and traceability of the detection report. The printing function is realized through the built-in printer, which can output a paper version of the detection report immediately for easy viewing and archiving by users; the storage function saves the detection report in the database inside the system, and users can query the historical detection reports through the automatic terminal control module for easy comparison analysis and data tracking.

[0066] Such as Figure 2As shown, in this embodiment, it should be specifically noted that a method for controlling an automated inspection process of biopharmaceuticals includes the following steps:

[0067] Step S01: Receive the inspection instruction input by the user, and control each module to perform an automated inspection process according to the inspection instruction;

[0068] Step S02: Automatically extract the target sample of the target to be detected from the storage container;

[0069] Step S03: Perform separation and purification operations on the received target sample using separation and purification technology equipment, and collect the quality impact parameters of the target sample after separation and purification;

[0070] Step S04: Obtain the purity index of the target sample after separation and purification through spectral analysis based on the quality impact parameters of the target sample after separation and purification;

[0071] Step S05: Perform mass determination of the molecules after lysis based on the quality impact parameters of the target sample after separation and purification to obtain the mass index of the target sample after separation and purification;

[0072] Step S06: Make a comprehensive judgment on the detection target based on the purity index and the mass index, and generate a detection report.

[0073] In this embodiment, it should be specifically noted that the main difference between this embodiment and the prior art is that this embodiment is provided with an automated terminal control module, a detection target sample extraction module, a target sample separation and purification module, a target sample purity analysis module, a mass determination module of molecules after lysis, and a comprehensive judgment module for detection targets. By using separation and purification technology equipment to perform separation and purification operations on the received target sample, it can initially remove impurities and ensure the activity of components, improving the accuracy and efficiency of biopharmaceutical inspection;

[0074] The purity index of the target sample after separation and purification is obtained through spectral analysis based on the quality impact parameters of the target sample after separation and purification. The mass index of the target sample after separation and purification is obtained by performing mass determination of the molecules after lysis based on the quality impact parameters of the target sample after separation and purification. A comprehensive judgment is made on the detection target based on the purity index and the mass index, reducing the risk of drug degradation during the detection process caused by adding solvents or directly detecting the drug, and at the same time reducing the risk of drug deterioration caused by impurity interference during the detection process.

[0075] Finally: The above are only the preferred embodiments of the present invention and are not used to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

[0076] As described above, it is only the specific implementation manner of the present application, but the protection scope of the present application is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present application can easily think of changes or substitutions, which should all be covered within the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims described above.

Claims

1. A biopharmaceutical automated inspection process control system, characterized in that: Including: Automated terminal control module, detection target sample extraction module, target sample separation and purification module, target sample purity analysis module, molecular mass determination module after lysis, and detection target comprehensive judgment module; The automated terminal control module is used to receive the inspection instructions input by the user and control each module to perform an automated inspection process according to the inspection instructions; The detection target sample extraction module is used to automatically extract the target sample of the to-be-detected target from the storage container and transmit the extracted target sample to the target sample separation and purification module; The target sample separation and purification module is used to receive the target sample transmitted by the detection target sample extraction module, perform separation and purification operations on the received target sample using separation and purification technical equipment, and collect the quality impact parameters of the target sample after separation and purification; The target sample purity analysis module obtains the purity index of the target sample after separation and purification through spectral analysis based on the quality impact parameters of the target sample after separation and purification, and transmits the purity index of the target sample after separation and purification to the detection target comprehensive judgment module; The molecular mass determination module after lysis determines the mass index of the target sample after separation and purification by measuring the mass of the molecules after lysis based on the quality impact parameters of the target sample after separation and purification, and transmits the mass degree index of the target sample after separation and purification to the detection target comprehensive judgment module; The detection target comprehensive judgment module is used to comprehensively judge the detection target based on the purity index and the mass index, generate a detection report, and feedback the detection report to the automated terminal control module.

2. The automated inspection process control system for biopharmaceuticals according to claim 1, wherein: In the automated terminal control module, there are a user instruction receiving unit and an inspection report receiving unit. The user instruction receiving unit is used to receive the inspection instructions input by the user and control each module to perform an automated inspection process according to the inspection instructions. The inspection report receiving unit is used to receive the inspection report transmitted by the detection target comprehensive judgment module and transmit the detection target to the qualified inspection area and the unqualified inspection area respectively according to the inspection report.

3. The automatic inspection process control system for biopharmaceuticals according to claim 1, characterized in that: In the detection target sample extraction module, a high-precision robotic arm and an intelligent recognition system are equipped for identifying and extracting the detection target sample.

4. The automatic inspection process control system for biopharmaceuticals according to claim 1, wherein: In the target sample separation and purification module, a high-performance liquid chromatograph is used to perform separation and purification operations on the target sample, and a high-precision mass monitoring instrument is used to monitor the quality impact parameters of the target sample after separation and purification in real time. The quality impact parameters include the target sample purity parameter and the molecular mass parameter of the target sample after lysis; The specific content for obtaining the target sample purity parameter is: performing near-infrared spectral interference on the target sample after separation and purification. When the vibration frequency of the infrared spectrum meets the preset standard, the near-infrared spectral interference operation is completed, and the target sample purity parameter is obtained. The target sample purity parameter includes: the photon energy when the near-infrared spectral interference operation is completed, the light source intensity when the near-infrared spectral interference operation is completed, and the optical path difference indicating when the near-infrared spectral interference operation is completed; The specific content for obtaining the molecular mass parameters after the target sample is pyrolyzed is as follows: The molecular mass parameters after the target sample is pyrolyzed are measured by a mass spectrometer, and the molecular mass parameters include the number of different types of molecules and the molecular weights of different types of molecules.

5. The automatic inspection process control system for biopharmaceuticals according to claim 1, wherein: In the target sample purity analysis module, the specific content for obtaining the purity index of the target sample after separation and purification through spectral analysis based on the mass influence parameters of the target sample after separation and purification is as follows: Perform near-infrared spectral interference on the separated and purified target sample, and perform spectral analysis based on the formed photon energy. Calculate the photon frequency of the target sample after spectral analysis. The calculation formula is as follows: Where v represents the photon frequency of the target sample after spectral analysis, E represents the photon energy when the near-infrared spectral interference operation is completed, and k represents Planck's constant; Based on the photon frequency of the target sample after spectral analysis, the optical path difference of near-infrared spectral interference is used as an independent variable and input into the near-infrared spectral interference model to calculate the interference intensity. The calculation formula is: Y(x) = U × cos(2π × v × x), where Y(x) represents the interference intensity of the near-infrared spectrum, U represents the light source intensity when the near-infrared spectral interference operation is completed, v represents the photon frequency of the target sample after spectral analysis, and x represents the optical path difference when the near-infrared spectral interference operation is completed; Calculate the purity index of the target sample after separation and purification based on the interference intensity of the near-infrared spectrum. The calculation formula is as follows: where Sy represents the purity index of the target sample, and Y(x) represents the interference intensity of the near-infrared spectrum. represents the preset interference intensity of the near-infrared spectrum.

6. The automatic inspection process control system for biopharmaceuticals according to claim 1, wherein: In the module for measuring the mass of molecules after pyrolysis, the specific content for measuring the mass of molecules after pyrolysis based on the mass influence parameters of the target sample after separation and purification to obtain the mass index of the target sample after separation and purification is as follows: Extract n types of molecules contained in the target sample after pyrolysis, where i = 1, 2, 3,..., n, and i represents the number of different molecules in the target sample after pyrolysis; Calculate the mass index of the target sample according to the molecular weights of different molecules in the target sample after cracking. The calculation formula is as follows: where Sx represents the mass index of the target sample, P i represents the number of the i-th type of molecule, M i represents the molecular weight of the i-th type of molecule, represents the number-average molecular weight, and the number-average molecular weight represents the result of the weighted average of various molecular weights according to their molar numbers.

7. The automated inspection process control system for biopharmaceuticals according to claim 1, characterized in that: In the detection target comprehensive judgment module, the specific content for comprehensively judging the detection target based on the purity index and the mass index and generating a detection report is as follows: A comprehensive judgment model is established based on the purity index and the quality index, and the expression of the model is: where D represents the output value of the comprehensive judgment model, Sy represents the purity index of the target sample, Sx represents the quality index of the target sample, and λ1 and λ2 represent the influence coefficients of the comprehensive detection of the target sample; Automatically inspect the detection target according to the output value of the comprehensive judgment model. If the output value of the comprehensive judgment model is greater than or equal to the preset judgment threshold, the automatic inspection is qualified; if the output value of the comprehensive judgment model is less than the preset judgment threshold, the automatic inspection is unqualified; Generate a detection report and transmit the inspection report to the automatic terminal control module. The detection target comprehensive judgment module has an automatic printing and storage function, and the user can query the historical detection report through the automatic terminal control module.

8. A method for controlling a biopharmaceutical automated inspection process, which is used for an automated inspection process control system for biopharmaceuticals described in any one of claims 1-7 above, and is characterized in that: It includes the following steps: Step S01: Receive the inspection instruction input by the user and control each module to perform the automatic inspection process according to the inspection instruction; Step S02: Automatically extract the target sample of the detection target from the storage container; Step S03: Use the separation and purification technical equipment to perform separation and purification operations on the received target sample and collect the mass influence parameters of the target sample after separation and purification; Step S04: Obtain the purity index of the target sample after separation and purification through spectral analysis based on the mass influence parameters of the target sample after separation and purification; Step S05: Measure the mass of molecules after pyrolysis based on the mass influence parameters of the target sample after separation and purification to obtain the mass index of the target sample after separation and purification; Step S06: Comprehensively judge the detection target based on the purity index and the mass index and generate a detection report.

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