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
Quality by Test (Qb T) was the only way to guarantee the quality of drug products before FDA launches current Good Manufacturing Practice (c GMP)[1], which is an approach without clear understanding of the processes. ...Quality by Test (Qb T) was the only way to guarantee the quality of drug products before FDA launches current Good Manufacturing Practice (c GMP)[1], which is an approach without clear understanding of the processes. In order to solve this problem,FDA generalized Quality by Design (QbD) in the field of pharmacy (2)In pharmaceutical industry, Qb D brings cost-efficiency and simplicity of manufacturing process into reality.展开更多
Pavements require maintenance to prevent undue distress or to restore performance; however, pavement maintenance and its impacts do not receive enough attention in many cases, and are either ignored or treated as a lo...Pavements require maintenance to prevent undue distress or to restore performance; however, pavement maintenance and its impacts do not receive enough attention in many cases, and are either ignored or treated as a low priority, Most current maintenance activities have budget issues and only focus on removing deteriorated pavement sections, Deferred pavement maintenance has impacts on the environment and on society, and may thus affect the costs associated with maintenance, A sustain- ability rating tool is a good way to list, explain, and evaluate such impacts, Various sustainahility rating tools have been developed for pavement; however, pavement maintenance has its own features that are different from those of the new construction, expansion, or reconstruction of pavements, This research project reviews nine sustainahility rating tools for pavement, although none of these tools fully describe maintenance features or can he directly applied to evaluate maintenance projects, A new sustainahility rating tool is then developed for pavement maintenance; this new tool can he used to evaluate individual projects and raise public awareness about the importance of pavement mainte- nance, Its details are described, and its use is demonstrated through an example to show the evaluation process and results,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 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.
文摘Quality by Test (Qb T) was the only way to guarantee the quality of drug products before FDA launches current Good Manufacturing Practice (c GMP)[1], which is an approach without clear understanding of the processes. In order to solve this problem,FDA generalized Quality by Design (QbD) in the field of pharmacy (2)In pharmaceutical industry, Qb D brings cost-efficiency and simplicity of manufacturing process into reality.
文摘Pavements require maintenance to prevent undue distress or to restore performance; however, pavement maintenance and its impacts do not receive enough attention in many cases, and are either ignored or treated as a low priority, Most current maintenance activities have budget issues and only focus on removing deteriorated pavement sections, Deferred pavement maintenance has impacts on the environment and on society, and may thus affect the costs associated with maintenance, A sustain- ability rating tool is a good way to list, explain, and evaluate such impacts, Various sustainahility rating tools have been developed for pavement; however, pavement maintenance has its own features that are different from those of the new construction, expansion, or reconstruction of pavements, This research project reviews nine sustainahility rating tools for pavement, although none of these tools fully describe maintenance features or can he directly applied to evaluate maintenance projects, A new sustainahility rating tool is then developed for pavement maintenance; this new tool can he used to evaluate individual projects and raise public awareness about the importance of pavement mainte- nance, Its details are described, and its use is demonstrated through an example to show the evaluation process and results,
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.
