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
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
The hydrogeological situation of the study area requires the identification of groundwater potential.Remote sensing and satellite data have proven to be reliable tools for understanding various factors that affect gro...The hydrogeological situation of the study area requires the identification of groundwater potential.Remote sensing and satellite data have proven to be reliable tools for understanding various factors that affect groundwater occurrence and movement.This study employed weighted overlay analysis based on satellite imagery and secondary data to create a thematic map for characterizing groundwater potentials in the study area located within Abbay Basin,Ethiopia.Remote sensing(RS)and GIS-based Fuzzy-Analytical Hierarchy Process methods were utilized to classify groundwater potential(GWP)zones into five categories:Very good,good,moderate,poor,and very poor.The central and eastern parts of the study area were identified as having high(33.186%)and very high(2.351%)groundwater potentials,while the western part exhibited poor and very poor potential areas.The groundwater potential map delineated higher and moderate potentials,suitable for installing shallow and production bores.This research demonstrates the effectiveness of RS and GIS techniques for delineating groundwater potential zones,which can aid in the planning and management of groundwater resources.The research findings have the potential to contribute to the formulation of improved groundwater management programs in the study area.展开更多
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 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.
文摘The hydrogeological situation of the study area requires the identification of groundwater potential.Remote sensing and satellite data have proven to be reliable tools for understanding various factors that affect groundwater occurrence and movement.This study employed weighted overlay analysis based on satellite imagery and secondary data to create a thematic map for characterizing groundwater potentials in the study area located within Abbay Basin,Ethiopia.Remote sensing(RS)and GIS-based Fuzzy-Analytical Hierarchy Process methods were utilized to classify groundwater potential(GWP)zones into five categories:Very good,good,moderate,poor,and very poor.The central and eastern parts of the study area were identified as having high(33.186%)and very high(2.351%)groundwater potentials,while the western part exhibited poor and very poor potential areas.The groundwater potential map delineated higher and moderate potentials,suitable for installing shallow and production bores.This research demonstrates the effectiveness of RS and GIS techniques for delineating groundwater potential zones,which can aid in the planning and management of groundwater resources.The research findings have the potential to contribute to the formulation of improved groundwater management programs in the study area.
