This study demonstrated the feasibility of implementing of MBR in pharmaceutical wastewater independently, and concluded different applications of MBR in industries. Membrane bioreactor (MBR) technology was a new wast...This study demonstrated the feasibility of implementing of MBR in pharmaceutical wastewater independently, and concluded different applications of MBR in industries. Membrane bioreactor (MBR) technology was a new wastewater treatment technology with a combination of membrane separation technology and biological treatment technology, which had unique advantages on pharmaceutical wastewater treatment. The modified membrane rector design provided a significantly lower concentration of NH3-N, Phosphorous, Total Nitrogen and COD around the membranes, and subsequently a more sustainable membrane performance due to much lower overall fouling rates. In this paper, the classification and structure of biological waste water treatment by using MBR technology were summed up along with some examples of MBR in industrial wastewater treatment, which was emphatically analyzed and discussed. Finally, the prospect of MBR in industrial wastewater treatment was described. The industrial wastewater was a high-strength wastewater which had characteristics of complicated constituents, high organics concentration, highly toxic.展开更多
Today the ASEAN Pharmaceutical manufacturing companies are still focusing on their local countries,with the exception of a fewlarge regionals who are already and increasingly looking and capable to export to the outsi...Today the ASEAN Pharmaceutical manufacturing companies are still focusing on their local countries,with the exception of a fewlarge regionals who are already and increasingly looking and capable to export to the outside markets such as Europe.This means that the majority of companies producing medicinal products to higher regulatory standards have less international experience/exposure in handling the GMP requirements demanded by PIC/s[1].In addition most of their processes are manual with legacy practices,and mostly the data and controls are in paper with a very high amount of data made with pen and paper on numerous human reviews of documentation mainly to assess the data is complete but not for accuracy of the data at the time that action could be taken—data integrity on paper has been shownto be highly questionable.展开更多
Pharmaceutical technology innovation process needs a lot of human, material and financial support, so the government must give full play to its financial support function. Specifically, the government should improve t...Pharmaceutical technology innovation process needs a lot of human, material and financial support, so the government must give full play to its financial support function. Specifically, the government should improve the fund investment mechanism of the pharmaceutical industry, improve the financial investment management system of pharmaceutical technology innovation, strengthen the function and mechanism of the capital market, improve the risk investment system, focus on cultivating a good credit environment, and increase the support of national policy-based financial institutions. Through direct investment, financial subsidies, tax incentives and low-interest financing and other means, vigorously promote the improvement of pharmaceutical innovation capacity.展开更多
Over the past few years,China’s extensive domestic power has been continually enhanced,and the economy,science,and technology are constantly evolving.Thus,people’s living standards have also been significantly impro...Over the past few years,China’s extensive domestic power has been continually enhanced,and the economy,science,and technology are constantly evolving.Thus,people’s living standards have also been significantly improved.In contemporary culture,individuals are increasingly demanding high-quality,safe lives and,on the one side,all regular necessities such as life-related,drug safety is a must attach huge significance.However,the state’s investment in medical care is not particularly large due to the late start of China’s medical industry.As a result,the pharmaceutical equipment of pharmaceutical companies in China still has many problems and there are potential hidden dangers in drug safety.The pharmaceutical companies in China are innovating on this basis.In technology,research and discussion,many problems appear and related solutions are proposed.展开更多
The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and techno...The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and technology transfer. This requires the technology transfer process to be regulated as the part of pharmaceutical quality system and the following development of corresponding written procedures. The following publication is dedicated to the development of TTP （technology transfer process） and its accessible graphic formalisation alongside the definition of main stages and possible procedures limited by the offered model. According to the actualized GMP rules, the technology transfer is an essential part of pharmaceutical quality system at a modem pharmaceutical company.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
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
Corporate Social Responsibility (CSR) activities have been revealed as an emerging managerial tool and research field. The socioeconomic impact of the COVID-19 pandemic has prompted several companies to take on CSR in...Corporate Social Responsibility (CSR) activities have been revealed as an emerging managerial tool and research field. The socioeconomic impact of the COVID-19 pandemic has prompted several companies to take on CSR initiatives. The objective of this study was to investigate CSR initiatives implemented in companies specializing in pharmaceutical and biomedical products as well as medical equipment, prior and during the COVID-19 pandemic. A cross-sectional study was conducted in companies of the Hellenic Association of Pharmaceutical Companies (SFEE), the Panhellenic Association of Pharmaceutical Industry (PEF) and the Association of Health-Research and Biotechnology Industry (SEIV). A self-administered questionnaire was distributed to a total of 112 companies. Descriptive and multivariate statistical analyses were performed using SPSS 25.0. Levels of significance were two-tailed and statistical significance was set at p = 0.05. The final sample consisted of 74 companies with a response rate of 77.7%. Among them 62.2% were multinational and 37.8% national companies. Some companies provided pharmaceuticals (40.5%), medical equipment and biotechnology products (32.4%) and others were specializing in both categories (27.1%). A percentage equal to 89.2% stated that they implemented CSR activities, out of which 75.7% carried out COVID-19 related initiatives, such as in public health (37.7%), societal issues (27.2%), environment (19.9%), etc. Approximately 50% increased their CSR activities during the pandemic. Moreover, the majority of companies devoted ≤30% of their total CSR budget against the pandemic. The higher a company’s turnover, the higher CSR activities performance. Pharmaceutical and biomedical companies in Greece implemented CSR actions, prior and during the pandemic. Companies contributed to handle the effects of health crisis through CSR Covid-19 related activities, which differentiated according to company’s culture and wealth. It is important that authorities should reward companies carrying out CSR initiatives, given that they positively contribute to the societal recovery by financially supporting the health care sector and the overall economy.展开更多
文摘This study demonstrated the feasibility of implementing of MBR in pharmaceutical wastewater independently, and concluded different applications of MBR in industries. Membrane bioreactor (MBR) technology was a new wastewater treatment technology with a combination of membrane separation technology and biological treatment technology, which had unique advantages on pharmaceutical wastewater treatment. The modified membrane rector design provided a significantly lower concentration of NH3-N, Phosphorous, Total Nitrogen and COD around the membranes, and subsequently a more sustainable membrane performance due to much lower overall fouling rates. In this paper, the classification and structure of biological waste water treatment by using MBR technology were summed up along with some examples of MBR in industrial wastewater treatment, which was emphatically analyzed and discussed. Finally, the prospect of MBR in industrial wastewater treatment was described. The industrial wastewater was a high-strength wastewater which had characteristics of complicated constituents, high organics concentration, highly toxic.
文摘Today the ASEAN Pharmaceutical manufacturing companies are still focusing on their local countries,with the exception of a fewlarge regionals who are already and increasingly looking and capable to export to the outside markets such as Europe.This means that the majority of companies producing medicinal products to higher regulatory standards have less international experience/exposure in handling the GMP requirements demanded by PIC/s[1].In addition most of their processes are manual with legacy practices,and mostly the data and controls are in paper with a very high amount of data made with pen and paper on numerous human reviews of documentation mainly to assess the data is complete but not for accuracy of the data at the time that action could be taken—data integrity on paper has been shownto be highly questionable.
文摘Pharmaceutical technology innovation process needs a lot of human, material and financial support, so the government must give full play to its financial support function. Specifically, the government should improve the fund investment mechanism of the pharmaceutical industry, improve the financial investment management system of pharmaceutical technology innovation, strengthen the function and mechanism of the capital market, improve the risk investment system, focus on cultivating a good credit environment, and increase the support of national policy-based financial institutions. Through direct investment, financial subsidies, tax incentives and low-interest financing and other means, vigorously promote the improvement of pharmaceutical innovation capacity.
文摘Over the past few years,China’s extensive domestic power has been continually enhanced,and the economy,science,and technology are constantly evolving.Thus,people’s living standards have also been significantly improved.In contemporary culture,individuals are increasingly demanding high-quality,safe lives and,on the one side,all regular necessities such as life-related,drug safety is a must attach huge significance.However,the state’s investment in medical care is not particularly large due to the late start of China’s medical industry.As a result,the pharmaceutical equipment of pharmaceutical companies in China still has many problems and there are potential hidden dangers in drug safety.The pharmaceutical companies in China are innovating on this basis.In technology,research and discussion,many problems appear and related solutions are proposed.
文摘The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and technology transfer. This requires the technology transfer process to be regulated as the part of pharmaceutical quality system and the following development of corresponding written procedures. The following publication is dedicated to the development of TTP （technology transfer process） and its accessible graphic formalisation alongside the definition of main stages and possible procedures limited by the offered model. According to the actualized GMP rules, the technology transfer is an essential part of pharmaceutical quality system at a modem pharmaceutical company.
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.
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Corporate Social Responsibility (CSR) activities have been revealed as an emerging managerial tool and research field. The socioeconomic impact of the COVID-19 pandemic has prompted several companies to take on CSR initiatives. The objective of this study was to investigate CSR initiatives implemented in companies specializing in pharmaceutical and biomedical products as well as medical equipment, prior and during the COVID-19 pandemic. A cross-sectional study was conducted in companies of the Hellenic Association of Pharmaceutical Companies (SFEE), the Panhellenic Association of Pharmaceutical Industry (PEF) and the Association of Health-Research and Biotechnology Industry (SEIV). A self-administered questionnaire was distributed to a total of 112 companies. Descriptive and multivariate statistical analyses were performed using SPSS 25.0. Levels of significance were two-tailed and statistical significance was set at p = 0.05. The final sample consisted of 74 companies with a response rate of 77.7%. Among them 62.2% were multinational and 37.8% national companies. Some companies provided pharmaceuticals (40.5%), medical equipment and biotechnology products (32.4%) and others were specializing in both categories (27.1%). A percentage equal to 89.2% stated that they implemented CSR activities, out of which 75.7% carried out COVID-19 related initiatives, such as in public health (37.7%), societal issues (27.2%), environment (19.9%), etc. Approximately 50% increased their CSR activities during the pandemic. Moreover, the majority of companies devoted ≤30% of their total CSR budget against the pandemic. The higher a company’s turnover, the higher CSR activities performance. Pharmaceutical and biomedical companies in Greece implemented CSR actions, prior and during the pandemic. Companies contributed to handle the effects of health crisis through CSR Covid-19 related activities, which differentiated according to company’s culture and wealth. It is important that authorities should reward companies carrying out CSR initiatives, given that they positively contribute to the societal recovery by financially supporting the health care sector and the overall economy.
