Process analytical technology(PAT) is gaining more interest in the biomanufacturing industry because of its potential to improve operational control and compliance through real-time quality assurance.Currently, biopha...Process analytical technology(PAT) is gaining more interest in the biomanufacturing industry because of its potential to improve operational control and compliance through real-time quality assurance.Currently, biopharmaceutical producers mainly monitor chromatographic processes with ultraviolet/visible(UV/Vis) absorbance. However, this measurement has a very limited correlation with purity and quantity. The current study aims to determine the concentration of monoclonal antibody(mAb) and host cell proteins(HCPs) using a build-in UV/Vis monitoring during Protein A affinity chromatography and to optimize the separation conditions for high purity of mAb and minimizing the HCPs content. The eluate was analyzed through in-line UV/Vis at 280 and 410 nm, representing mAb and HCPs concentration,respectively. Each 0.1 column volume(CV) fraction of UV/Vis chromatogram peak area were calculated,and different separation conditions were then compared. The optimum conditions of mAb separation were found as 12 CV loading, elution at pH 3.5, and starting the collection at 0.5 CV point, resulting in high m Ab recovery of 95.92% and additional removal of 49.98% of HCP comparing with whole elution pool. This study concluded that UV/Vis-based in-line monitoring at 280 and 410 nm showed a high potential to optimize and real-time control Protein A affinity chromatography for mAb purification from HCPs.展开更多
Downstream processing or product recovery plays a vital role in the development of bioprocesses.To improve the bioprocess efficiency,some unconventional methods are much required.The continuous manufacturing in downst...Downstream processing or product recovery plays a vital role in the development of bioprocesses.To improve the bioprocess efficiency,some unconventional methods are much required.The continuous manufacturing in downstream processing makes the Process Analytical Technologies(PATs)as an important tool.Monitoring and controlling bioprocess are an essential factor for the principles of PAT and quality by design.Spectroscopic methods can apply to monitor multiple analytes in real-time with less sample processing with significant advancements.Raman spectroscopy is an extensively used technique as an analytical and research tool owing to its modest process form,non-destructive,non-invasive optical molecular spectroscopic imaging with computer-based analysis.Generally,its application is essential for the analysis and characterization of biological samples,and it is easy to operate with minimal sample.The innovation on various types of enhanced Raman spectroscopy was designed to enhance the Raman analytical technique.Raman spectroscopy could couple with chemometrics to provide reliable alternative analysis method of downstream process analysis.Thus,this review aims to provide useful insight on the application of Raman spectroscopy for PAT in downstream processing of biotechnology and Raman data analysis in biological fields.展开更多
Film coating is an important unit operation to produce solid dosage forms,thereby,the monitoring of this process is helpful to find problems in time and improve the quality of coated products.Traditional methods adopt...Film coating is an important unit operation to produce solid dosage forms,thereby,the monitoring of this process is helpful to find problems in time and improve the quality of coated products.Traditional methods adopted to monitor this process include measurement of coating weight gain,performance of disintegration and dissolution test,etc.However,not only do these methods cause destruction to the samples,but also consume time and energy.There have recently emerged the applications of process analytical technologies(PAT)on film coating,especially some novel spectroscopic and imaging technologies,which have the potential to real-time track the progress in film coating and optimize production efficiency.This article gives an overview on the application of such technologies for film coating,with the goal to provide a reference for the further researches.展开更多
The pharmaceutical industry is now paying increased attention to continuous manufacturing.While the revolution to continuous and automated manufacturing is deepening in most of the top pharma companies in the world,th...The pharmaceutical industry is now paying increased attention to continuous manufacturing.While the revolution to continuous and automated manufacturing is deepening in most of the top pharma companies in the world,the advancement of automated pharmaceutical continuous manufacturing in China is relatively slow due to some key challenges including the lack of knowledge on the related technologies and shortage of qualified personnels.In this review,emphasis is given to two of the crucial technologies in automated pharmaceutical continuous manufacturing,i.e.,process analytical technology(PAT)and self-optimizing algorithm.Research work published in recent 5 years employing advanced PAT tools and self-optimization algorithms is introduced,which represents the great progress that has been made in automated pharmaceutical continuous manufacturing.展开更多
This study was undertaken to develop a numerical process that can be used as a quality criterion to determine the technological value of the Egyptian cotton varieties, which in turn would denote the end-use of their f...This study was undertaken to develop a numerical process that can be used as a quality criterion to determine the technological value of the Egyptian cotton varieties, which in turn would denote the end-use of their fibers. However the material used in the study comprised the 6 Egyptian cotton varieties Giza70, Giza80, Giza86, Giza88, Giza90 and Giza92. According to the local practice in Egypt, Giza70, Giza88 and Giza92 belong to the Extra-Long Staple (ELS) category, while Giza80, Giza86 and Giza90 are included under the Long Staple (LS) category. The regression analysis of the relationships between fiber properties and yarn skein strength (lea product) of the 2 carded ring counts 40 and 50 Ne, was employed to drive an equation for calculating the Multiplicative Analytic Hierarchy Process (MIAHP) values. The values of the MIAHP have been used as numerical determinations of the technological values of the Egyptian cotton varieties. Nevertheless, the findings of this study clarified that with respect to the criteria weights, the pair-wise comparisons denoted that fiber length properties of Egyptian cotton ranked first where they revealed the most dominant effect on yarn strength, while tensile properties ranked second with a relative weight close to that of fiber length. On the contrary, the relative weight of fiber fineness (micronaire reading) was found to be marginal. With regard to the relative weight of sub-criterion, the pair-wise comparisons indicated that the role of fiber tenacity as a determinant of yarn strength is much superior to that of fiber elongation. Further the global weights of the sub-criterion of fiber length pointed out that the UHML (upper half mean length) plays an important role in determining yarn strength of the Egyptian cotton comparing with either the UI (uniformity index) or the SFC (short fiber content). In conformity with the values of the MIAHP, it was found that in the order of descending rank, Giza88 ranked first, followed by Giza92, Giza70, Giza86, Giza80 and finally Giza90.展开更多
Organizational computing devices are increasingly becoming targets of cyber-attacks, and organizations have become dependent on the safety and security of their computer networks and their organizational computing dev...Organizational computing devices are increasingly becoming targets of cyber-attacks, and organizations have become dependent on the safety and security of their computer networks and their organizational computing devices. Business and government often use defense in-depth information assurance measures such as firewalls, intrusion detection systems, and password procedures across their enterprises to plan strategically and manage IT security risks. This quantitative study explores whether the analytical hierarchy process (AHP) model can be effectively applied to the prioritization of information assurance defense in-depth measures. In response to these threats, the President, legislators, experts, and others have characterized cyber security as a pressing national security issue. The methods used in this study consisted of emailing study participants a survey requesting that they prioritize five defense in-depth information assurance measures, anti-virus, intrusion detection, password, smart-cards, and encryption, with a range of responses from 1 - 5 using a Likert scale to consider standard cost, effectiveness, and perceived ease of use in terms of protection of organizational computing devices. The measures were then weighted, based on ranking. A pair-wise comparison of each of the five measures is then made using AHP to determine whether the Likert scale and the AHP model could be effectively applied to the prioritization of information assurance measures to protect organizational computing devices. The findings of the research reject the H0 null hypothesis that AHP does not affect the relationship between the information technology analysts’ prioritization of five defense in-depth dependent variables and the independent variables of cost, ease of use, and effectiveness in protecting organizational devices against cyber-attacks.展开更多
The East Kolkata Wetlands (EKW) is located on the eastern periphery of the city of Kolkata and extends up to theBidyadhari-Matla River confluence. It is a Ramsar Site and acts as an absorber basin for a large number o...The East Kolkata Wetlands (EKW) is located on the eastern periphery of the city of Kolkata and extends up to theBidyadhari-Matla River confluence. It is a Ramsar Site and acts as an absorber basin for a large number of con-taminants drained from Kolkata. Agricultural lands, sewage-fed fisheries, garbage dumping fields, horticulture,and built-up areas are included in this protected area, that covers approximately 125 km2. It reveals that climatechange reduces the variety of wetland ecosystem services and increases socio-economic vulnerability and eco-nomic stress. The human encroachment, reclamation of land for agriculture, aquaculture, and urban expansion inand around Kolkata has recently adversely threatened the EKW. The remotely sensed data, socio-economic data,and responses of inhabitants have been used to analyse the EKW’s risk and vulnerability. We employed geospatialanalysis by using the Multi-Criteria Decision Making (MCDM) method using nine risk factors. An in-depth analysisof the EKW using geospatial techniques and the Fuzzy Analytic Hierarchy Process (FAHP) helped to understandthe EKW transformations through vulnerability and risk analysis. The results show that the transformation of thewetland to aquaculture, eutrophication and pollution, road proximity, waste dumping, population density, andgrowth are the main factors for the deteriorating health, quality, and environment of the EKW. It also reveals thatquantitative and qualitative evaluations of ecosystem services, wetland degradation, transformation, and cause-effect rapport should be periodically assessed using scientific methods like FAHP, RS, GIS to formulate resilient,integrated plans and strategy for the sustainable management of the EKW.展开更多
Objective:A novel processing analytical framework of Chinese Material Medica (CMM) includes breeding process analysis,planting process analysis,producing process analysis and manufacture process analysis.In order to s...Objective:A novel processing analytical framework of Chinese Material Medica (CMM) includes breeding process analysis,planting process analysis,producing process analysis and manufacture process analysis.In order to study this framework,we used quality control of honeysuckle flower (Lonicerae japonicae Flos) including diploid and tetraploid Lonicera japonica,and wild honeysuckle flower (Lonicerae Flos) including Lonicerae hypoglauca,Lonicerae confusa,Lonicerae fulvotomentosa and Lonicerae macranthoides as an example.Methods:A total of 360 samples were analyzed from three variables including species,growing areas,and optimization of processing methods.For quantitative analysis,chlorogenic acid (CA),isochlorogenic acid A (3,5-DCA),and isochlorogenic acid C (4,5-DCA) were measured with high performance liquid chromatography (HPLC).Results:The three organic acids contents are higher in wild honeysuckle flower than honeysuckle flower;L.japonica (tetraploid) is higher than L.japonica (diploid).Modern processing methods (kill-enzyme torrefaction and fixing machine drying) are popular in growing areas and are superior to traditional methods (sun and shade drying).Conclusions:Novel process analysis concepts in processing analytical technology (PAT) enriched the Chinese MateHal Medica contents.展开更多
Pharmaceutical production is changing from batch production to continuous production,during which granulation is one of the most important unit operations.The quality of mass-produced products is traditionally guarant...Pharmaceutical production is changing from batch production to continuous production,during which granulation is one of the most important unit operations.The quality of mass-produced products is traditionally guaranteed by conducting off-line testing,which cannot meet the demand of continuous production for real-time monitoring of critical process parameters and critical quality attributes(CQAs)of the pharmaceutical granulation technology.Since the U.S.Food and Drug Administration proposed process analytical technology(PAT)in 2004,many PAT tools have been developed to monitor the granulation process and provide information regarding the granulation operation conditions and endpoint determination.In this article,we review the recent research and application of two PAT modes in the granulation process,namely,single CQA and multi-CQA PAT,with the aim to provide references for comprehensively improving the technological level of the pharmaceutical granulation process.Furthermore,the potential applications in traditional Chinese Medicine are discussed.展开更多
The automation of traditional Chinese medicine(TCM)pharmaceuticals has driven the development of process analysis from offline to online.Most of common online process analytical technologies are based on spectroscopy,...The automation of traditional Chinese medicine(TCM)pharmaceuticals has driven the development of process analysis from offline to online.Most of common online process analytical technologies are based on spectroscopy,making the identification and quantification of specific ingredients still a challenge.Herein,we developed a quality control(QC)system for monitoring TCM pharmaceuticals based on paper spray ionization miniature mass spectrometry(mini-MS).It enabled real-time online qualitative and quantitative detection of target ingredients in herbal extracts using mini-MS without chromatographic separation for the first time.Dynamic changes of alkaloids in Aconiti Lateralis Radix Praeparata(Fuzi)during decoction were used as examples,and the scientific principle of Fuzi compatibility was also investigated.Finally,the system was verified to work stably at the hourly level for pilot-scale extraction.This mini-MS based online analytical system is expected to be further developed for QC applications in a wider range of pharmaceutical processes.展开更多
Recent research carried out in the public sector shows that outsourcing can indisputably bring many benefits to the organizations which master the art of devising, deploying and maintaining outsourcing relationships. ...Recent research carried out in the public sector shows that outsourcing can indisputably bring many benefits to the organizations which master the art of devising, deploying and maintaining outsourcing relationships. However, for many organizations, these benefits remain elusive, while outsourcing projects are usually accompanied by unexpected and often negative effects. The paper focuses on in-depth analysis of the current situation concerning outsourcing of information technology projects （IT-projects） in Slovenian public sector. Presented research initially analyses substantive, procedural and other relevant aspects of outsourcing and provides a set of applicable decision making criteria. Stemming from the analysis results, this paper eventually presents the development of a multi criteria decision-support model based on Analytic Hierarchy Process （AHP） which could facilitate enhanced evaluation, selection and implementation of IT outsourcing projects in the public sector.展开更多
Selecting the promising technologies to incorporate in new products is challenging for enterprises, especially for those who compete in emerging high-technology industries. By integrating external factor evaluation （...Selecting the promising technologies to incorporate in new products is challenging for enterprises, especially for those who compete in emerging high-technology industries. By integrating external factor evaluation （EFE） and internal factor evaluation （1FE） matrix, this study proposes a new technology selection method. The proposed fi＇am^work is applied to a real technology selection problem faced by a bio-technology enterprise in the context of China＇ s economic, political and social environment. Two major aspects and 24 external/internal factors are determined. This study uses analytic hierarchy process （AHP） method to sort the information and derives weights of each criterion. Empirical results indicate that the candidate technology is promising, and shall be developed as one of the enterprise＇s primary products.展开更多
For optimization of production processes and product quality,often knowledge of the factors influencing the process outcome is compulsory.Thus,process analytical technology(PAT)that allows deeper insight into the proc...For optimization of production processes and product quality,often knowledge of the factors influencing the process outcome is compulsory.Thus,process analytical technology(PAT)that allows deeper insight into the process and results in a mathematical description of the process behavior as a simple function based on the most important process factors can help to achieve higher production efficiency and quality.The present study aims at characterizing a well-known industrial process,the transesterification reaction of rapeseed oil with methanol to produce fatty acid methyl esters(FAME)for usage as biodiesel in a continuous micro reactor set-up.To this end,a design of experiment approach is applied,where the effects of two process factors,the molar ratio and the total flow rate of the reactants,are investigated.The optimized process target response is the FAME mass fraction in the purified nonpolar phase of the product as a measure of reaction yield.The quantification is performed using attenuated total reflection infrared spectroscopy in combination with partial least squares regression.The data retrieved during the conduction of the DoE experimental plan were used for statistical analysis.A non-linear model indicating a synergistic interaction between the studied factors describes the reactor behavior with a high coefficient of determination(R^(2))of 0.9608.Thus,we applied a PAT approach to generate further insight into this established industrial process.展开更多
Compared to small molecule process analytical technology （PAT） applications, biotechnology product PAT applications have certain unique challenges and opportunities. Understanding process dynamics of bioreactor cell...Compared to small molecule process analytical technology （PAT） applications, biotechnology product PAT applications have certain unique challenges and opportunities. Understanding process dynamics of bioreactor cell culture process is essential to establish an appropriate process control strategy for biotechnology product PAT applications. Inline spectroscopic techniques for real time monitoring of bioreactor cell culture process have the distinct potential to develop PAT approaches in manufac- turing biotechnology drug products. However, the use of inline Fourier transform infrared （FTIR） spectroscopic techniques for bioreactor cell culture process monitoring has not been reported. In this work, real time inline FTIR Spectroscopy was applied to a lab scale bioreactor mAb IgG3 cell culture fluid biomolecular dynamic model. The technical feasibility of using FTIR Spectroscopy for real time tracking and monitoring four key cell culture metabolites （including glucose, glutamine, lactate, and ammonia） and protein yield at increasing levels of complexity （simple binary system, fully formulated media, actual bioreactor cell culture process） was evaluated via a stepwise approach. The FTIR fingerprints of the key metabolites were identified. The multivariate partial least squares （PLS） calibration models were established to correlate the process FTIR spectra with the concentrations of key metabolites and protein yield of in-process samples, either individually for each metabolite and protein or globally for all four metabolites simultaneously. Applying the 2＇ld derivative pre-processing algorithm to the FTIR spectra helps to reduce the number of PLS latent variables needed significantly and thus simplify the interpretation of the PLS models. The validated PLS models show promise in predicting the concentration profiles of glucose, glutamine, lactate, and ammonia and protein yield over the course of the bioreactor cell culture process. Therefore, this work demonstrated the technical feasibility of real time monitoring of the bioreactor cell culture process via FTIR spectroscopy. Its implications for enabling cell culture PAT were discussed.展开更多
基金supported by the National Key Research & Development Program of China (2021YFE0113300)the National Natural Science Foundation of China (22078286 and 21878263)+1 种基金Zhejiang Universitythe Talent-Introduction Program of China for the Postdoctoral Researcher for the financial support。
文摘Process analytical technology(PAT) is gaining more interest in the biomanufacturing industry because of its potential to improve operational control and compliance through real-time quality assurance.Currently, biopharmaceutical producers mainly monitor chromatographic processes with ultraviolet/visible(UV/Vis) absorbance. However, this measurement has a very limited correlation with purity and quantity. The current study aims to determine the concentration of monoclonal antibody(mAb) and host cell proteins(HCPs) using a build-in UV/Vis monitoring during Protein A affinity chromatography and to optimize the separation conditions for high purity of mAb and minimizing the HCPs content. The eluate was analyzed through in-line UV/Vis at 280 and 410 nm, representing mAb and HCPs concentration,respectively. Each 0.1 column volume(CV) fraction of UV/Vis chromatogram peak area were calculated,and different separation conditions were then compared. The optimum conditions of mAb separation were found as 12 CV loading, elution at pH 3.5, and starting the collection at 0.5 CV point, resulting in high m Ab recovery of 95.92% and additional removal of 49.98% of HCP comparing with whole elution pool. This study concluded that UV/Vis-based in-line monitoring at 280 and 410 nm showed a high potential to optimize and real-time control Protein A affinity chromatography for mAb purification from HCPs.
基金This work was supported by the National Natural Science Foundation of China(No.21878263,22078286)。
文摘Downstream processing or product recovery plays a vital role in the development of bioprocesses.To improve the bioprocess efficiency,some unconventional methods are much required.The continuous manufacturing in downstream processing makes the Process Analytical Technologies(PATs)as an important tool.Monitoring and controlling bioprocess are an essential factor for the principles of PAT and quality by design.Spectroscopic methods can apply to monitor multiple analytes in real-time with less sample processing with significant advancements.Raman spectroscopy is an extensively used technique as an analytical and research tool owing to its modest process form,non-destructive,non-invasive optical molecular spectroscopic imaging with computer-based analysis.Generally,its application is essential for the analysis and characterization of biological samples,and it is easy to operate with minimal sample.The innovation on various types of enhanced Raman spectroscopy was designed to enhance the Raman analytical technique.Raman spectroscopy could couple with chemometrics to provide reliable alternative analysis method of downstream process analysis.Thus,this review aims to provide useful insight on the application of Raman spectroscopy for PAT in downstream processing of biotechnology and Raman data analysis in biological fields.
基金supported by National Natural Science Foundation of China(81202476)Medical Research Foundation of Guangdong Province(B2012079).
文摘Film coating is an important unit operation to produce solid dosage forms,thereby,the monitoring of this process is helpful to find problems in time and improve the quality of coated products.Traditional methods adopted to monitor this process include measurement of coating weight gain,performance of disintegration and dissolution test,etc.However,not only do these methods cause destruction to the samples,but also consume time and energy.There have recently emerged the applications of process analytical technologies(PAT)on film coating,especially some novel spectroscopic and imaging technologies,which have the potential to real-time track the progress in film coating and optimize production efficiency.This article gives an overview on the application of such technologies for film coating,with the goal to provide a reference for the further researches.
基金supported by the National Natural Science Foundation of China(Nos.21808059,21878088,and 21476077)Key Project of the Shanghai Science and Technology Committee(No.18DZ1112703)。
文摘The pharmaceutical industry is now paying increased attention to continuous manufacturing.While the revolution to continuous and automated manufacturing is deepening in most of the top pharma companies in the world,the advancement of automated pharmaceutical continuous manufacturing in China is relatively slow due to some key challenges including the lack of knowledge on the related technologies and shortage of qualified personnels.In this review,emphasis is given to two of the crucial technologies in automated pharmaceutical continuous manufacturing,i.e.,process analytical technology(PAT)and self-optimizing algorithm.Research work published in recent 5 years employing advanced PAT tools and self-optimization algorithms is introduced,which represents the great progress that has been made in automated pharmaceutical continuous manufacturing.
文摘This study was undertaken to develop a numerical process that can be used as a quality criterion to determine the technological value of the Egyptian cotton varieties, which in turn would denote the end-use of their fibers. However the material used in the study comprised the 6 Egyptian cotton varieties Giza70, Giza80, Giza86, Giza88, Giza90 and Giza92. According to the local practice in Egypt, Giza70, Giza88 and Giza92 belong to the Extra-Long Staple (ELS) category, while Giza80, Giza86 and Giza90 are included under the Long Staple (LS) category. The regression analysis of the relationships between fiber properties and yarn skein strength (lea product) of the 2 carded ring counts 40 and 50 Ne, was employed to drive an equation for calculating the Multiplicative Analytic Hierarchy Process (MIAHP) values. The values of the MIAHP have been used as numerical determinations of the technological values of the Egyptian cotton varieties. Nevertheless, the findings of this study clarified that with respect to the criteria weights, the pair-wise comparisons denoted that fiber length properties of Egyptian cotton ranked first where they revealed the most dominant effect on yarn strength, while tensile properties ranked second with a relative weight close to that of fiber length. On the contrary, the relative weight of fiber fineness (micronaire reading) was found to be marginal. With regard to the relative weight of sub-criterion, the pair-wise comparisons indicated that the role of fiber tenacity as a determinant of yarn strength is much superior to that of fiber elongation. Further the global weights of the sub-criterion of fiber length pointed out that the UHML (upper half mean length) plays an important role in determining yarn strength of the Egyptian cotton comparing with either the UI (uniformity index) or the SFC (short fiber content). In conformity with the values of the MIAHP, it was found that in the order of descending rank, Giza88 ranked first, followed by Giza92, Giza70, Giza86, Giza80 and finally Giza90.
文摘Organizational computing devices are increasingly becoming targets of cyber-attacks, and organizations have become dependent on the safety and security of their computer networks and their organizational computing devices. Business and government often use defense in-depth information assurance measures such as firewalls, intrusion detection systems, and password procedures across their enterprises to plan strategically and manage IT security risks. This quantitative study explores whether the analytical hierarchy process (AHP) model can be effectively applied to the prioritization of information assurance defense in-depth measures. In response to these threats, the President, legislators, experts, and others have characterized cyber security as a pressing national security issue. The methods used in this study consisted of emailing study participants a survey requesting that they prioritize five defense in-depth information assurance measures, anti-virus, intrusion detection, password, smart-cards, and encryption, with a range of responses from 1 - 5 using a Likert scale to consider standard cost, effectiveness, and perceived ease of use in terms of protection of organizational computing devices. The measures were then weighted, based on ranking. A pair-wise comparison of each of the five measures is then made using AHP to determine whether the Likert scale and the AHP model could be effectively applied to the prioritization of information assurance measures to protect organizational computing devices. The findings of the research reject the H0 null hypothesis that AHP does not affect the relationship between the information technology analysts’ prioritization of five defense in-depth dependent variables and the independent variables of cost, ease of use, and effectiveness in protecting organizational devices against cyber-attacks.
基金The authors would like to thank the Netaji Subhas Open Uni-versity,Kolkata,for providing the supportive research funding(No.AC/140/2021-22).
文摘The East Kolkata Wetlands (EKW) is located on the eastern periphery of the city of Kolkata and extends up to theBidyadhari-Matla River confluence. It is a Ramsar Site and acts as an absorber basin for a large number of con-taminants drained from Kolkata. Agricultural lands, sewage-fed fisheries, garbage dumping fields, horticulture,and built-up areas are included in this protected area, that covers approximately 125 km2. It reveals that climatechange reduces the variety of wetland ecosystem services and increases socio-economic vulnerability and eco-nomic stress. The human encroachment, reclamation of land for agriculture, aquaculture, and urban expansion inand around Kolkata has recently adversely threatened the EKW. The remotely sensed data, socio-economic data,and responses of inhabitants have been used to analyse the EKW’s risk and vulnerability. We employed geospatialanalysis by using the Multi-Criteria Decision Making (MCDM) method using nine risk factors. An in-depth analysisof the EKW using geospatial techniques and the Fuzzy Analytic Hierarchy Process (FAHP) helped to understandthe EKW transformations through vulnerability and risk analysis. The results show that the transformation of thewetland to aquaculture, eutrophication and pollution, road proximity, waste dumping, population density, andgrowth are the main factors for the deteriorating health, quality, and environment of the EKW. It also reveals thatquantitative and qualitative evaluations of ecosystem services, wetland degradation, transformation, and cause-effect rapport should be periodically assessed using scientific methods like FAHP, RS, GIS to formulate resilient,integrated plans and strategy for the sustainable management of the EKW.
基金Financial support of this work from National Natural Science Foundation of China(No.31370360 and No.81303218)National Science and Technology Support Programme(No.2011BAI07B07)Independent Subject of Beijing University of Chinese Medicine(No:JYBZZ-7S016)are gratefully acknowledged.
文摘Objective:A novel processing analytical framework of Chinese Material Medica (CMM) includes breeding process analysis,planting process analysis,producing process analysis and manufacture process analysis.In order to study this framework,we used quality control of honeysuckle flower (Lonicerae japonicae Flos) including diploid and tetraploid Lonicera japonica,and wild honeysuckle flower (Lonicerae Flos) including Lonicerae hypoglauca,Lonicerae confusa,Lonicerae fulvotomentosa and Lonicerae macranthoides as an example.Methods:A total of 360 samples were analyzed from three variables including species,growing areas,and optimization of processing methods.For quantitative analysis,chlorogenic acid (CA),isochlorogenic acid A (3,5-DCA),and isochlorogenic acid C (4,5-DCA) were measured with high performance liquid chromatography (HPLC).Results:The three organic acids contents are higher in wild honeysuckle flower than honeysuckle flower;L.japonica (tetraploid) is higher than L.japonica (diploid).Modern processing methods (kill-enzyme torrefaction and fixing machine drying) are popular in growing areas and are superior to traditional methods (sun and shade drying).Conclusions:Novel process analysis concepts in processing analytical technology (PAT) enriched the Chinese MateHal Medica contents.
基金the National Natural Sciences Foundation of China(No.82074276)Tianjin Science and Technology project(No.20ZYJDJC00090).
文摘Pharmaceutical production is changing from batch production to continuous production,during which granulation is one of the most important unit operations.The quality of mass-produced products is traditionally guaranteed by conducting off-line testing,which cannot meet the demand of continuous production for real-time monitoring of critical process parameters and critical quality attributes(CQAs)of the pharmaceutical granulation technology.Since the U.S.Food and Drug Administration proposed process analytical technology(PAT)in 2004,many PAT tools have been developed to monitor the granulation process and provide information regarding the granulation operation conditions and endpoint determination.In this article,we review the recent research and application of two PAT modes in the granulation process,namely,single CQA and multi-CQA PAT,with the aim to provide references for comprehensively improving the technological level of the pharmaceutical granulation process.Furthermore,the potential applications in traditional Chinese Medicine are discussed.
基金supported by Ministry of Science and Technology of the People's Republic of China(Grant No.:2022YFC3502300)Beijing Natural Science Foundation(Grant No.:L222150)+2 种基金the National Natural Science Foundation of China(Grant No.:82072247)the second batch of“Ten thousand plan”National High Level Talents Special Support Plan(Grant No.:W02020052)Beijing University of Chinese Medicine(Grant Nos.:XJYS21005,JY21024,MSGZF-202001,2022-syjs-05,and 2022-syjs-10).
文摘The automation of traditional Chinese medicine(TCM)pharmaceuticals has driven the development of process analysis from offline to online.Most of common online process analytical technologies are based on spectroscopy,making the identification and quantification of specific ingredients still a challenge.Herein,we developed a quality control(QC)system for monitoring TCM pharmaceuticals based on paper spray ionization miniature mass spectrometry(mini-MS).It enabled real-time online qualitative and quantitative detection of target ingredients in herbal extracts using mini-MS without chromatographic separation for the first time.Dynamic changes of alkaloids in Aconiti Lateralis Radix Praeparata(Fuzi)during decoction were used as examples,and the scientific principle of Fuzi compatibility was also investigated.Finally,the system was verified to work stably at the hourly level for pilot-scale extraction.This mini-MS based online analytical system is expected to be further developed for QC applications in a wider range of pharmaceutical processes.
文摘Recent research carried out in the public sector shows that outsourcing can indisputably bring many benefits to the organizations which master the art of devising, deploying and maintaining outsourcing relationships. However, for many organizations, these benefits remain elusive, while outsourcing projects are usually accompanied by unexpected and often negative effects. The paper focuses on in-depth analysis of the current situation concerning outsourcing of information technology projects （IT-projects） in Slovenian public sector. Presented research initially analyses substantive, procedural and other relevant aspects of outsourcing and provides a set of applicable decision making criteria. Stemming from the analysis results, this paper eventually presents the development of a multi criteria decision-support model based on Analytic Hierarchy Process （AHP） which could facilitate enhanced evaluation, selection and implementation of IT outsourcing projects in the public sector.
文摘Selecting the promising technologies to incorporate in new products is challenging for enterprises, especially for those who compete in emerging high-technology industries. By integrating external factor evaluation （EFE） and internal factor evaluation （1FE） matrix, this study proposes a new technology selection method. The proposed fi＇am^work is applied to a real technology selection problem faced by a bio-technology enterprise in the context of China＇ s economic, political and social environment. Two major aspects and 24 external/internal factors are determined. This study uses analytic hierarchy process （AHP） method to sort the information and derives weights of each criterion. Empirical results indicate that the candidate technology is promising, and shall be developed as one of the enterprise＇s primary products.
文摘For optimization of production processes and product quality,often knowledge of the factors influencing the process outcome is compulsory.Thus,process analytical technology(PAT)that allows deeper insight into the process and results in a mathematical description of the process behavior as a simple function based on the most important process factors can help to achieve higher production efficiency and quality.The present study aims at characterizing a well-known industrial process,the transesterification reaction of rapeseed oil with methanol to produce fatty acid methyl esters(FAME)for usage as biodiesel in a continuous micro reactor set-up.To this end,a design of experiment approach is applied,where the effects of two process factors,the molar ratio and the total flow rate of the reactants,are investigated.The optimized process target response is the FAME mass fraction in the purified nonpolar phase of the product as a measure of reaction yield.The quantification is performed using attenuated total reflection infrared spectroscopy in combination with partial least squares regression.The data retrieved during the conduction of the DoE experimental plan were used for statistical analysis.A non-linear model indicating a synergistic interaction between the studied factors describes the reactor behavior with a high coefficient of determination(R^(2))of 0.9608.Thus,we applied a PAT approach to generate further insight into this established industrial process.
文摘Compared to small molecule process analytical technology （PAT） applications, biotechnology product PAT applications have certain unique challenges and opportunities. Understanding process dynamics of bioreactor cell culture process is essential to establish an appropriate process control strategy for biotechnology product PAT applications. Inline spectroscopic techniques for real time monitoring of bioreactor cell culture process have the distinct potential to develop PAT approaches in manufac- turing biotechnology drug products. However, the use of inline Fourier transform infrared （FTIR） spectroscopic techniques for bioreactor cell culture process monitoring has not been reported. In this work, real time inline FTIR Spectroscopy was applied to a lab scale bioreactor mAb IgG3 cell culture fluid biomolecular dynamic model. The technical feasibility of using FTIR Spectroscopy for real time tracking and monitoring four key cell culture metabolites （including glucose, glutamine, lactate, and ammonia） and protein yield at increasing levels of complexity （simple binary system, fully formulated media, actual bioreactor cell culture process） was evaluated via a stepwise approach. The FTIR fingerprints of the key metabolites were identified. The multivariate partial least squares （PLS） calibration models were established to correlate the process FTIR spectra with the concentrations of key metabolites and protein yield of in-process samples, either individually for each metabolite and protein or globally for all four metabolites simultaneously. Applying the 2＇ld derivative pre-processing algorithm to the FTIR spectra helps to reduce the number of PLS latent variables needed significantly and thus simplify the interpretation of the PLS models. The validated PLS models show promise in predicting the concentration profiles of glucose, glutamine, lactate, and ammonia and protein yield over the course of the bioreactor cell culture process. Therefore, this work demonstrated the technical feasibility of real time monitoring of the bioreactor cell culture process via FTIR spectroscopy. Its implications for enabling cell culture PAT were discussed.
