Objective To explore the current state of biopharmaceutical innovation in Africa by analyzing patent data related to biopharmaceutical products in African countries.Methods Based on patent data,simple descriptive stat...Objective To explore the current state of biopharmaceutical innovation in Africa by analyzing patent data related to biopharmaceutical products in African countries.Methods Based on patent data,simple descriptive statistical methods were used to analyze the trend of patent applications,the geographical distribution of patents,and the distribution of applicants in the pharmaceutical field in Africa.Besides,Excel software was used to draw charts to visualize statistical information.Results and Conclusion According to the result,a large number of patents has been granted in these countries and the number is steadily rising each year.From the figure below,we can see that the largest number of patents was granted to Morocco in 2014 with a total number of 613 patents followed by Tunisia with 315 patents,the African Intellectual Property Organization(OAPI)with 124 patents,South Africa with 106 and Mozambique with 1 patent based on data availability(IncoPat Global Patent Search Database).It was observed that,as patents were granted,the number of applications filed on this continent increased.The largest number of patents has been recorded by Morocco,Tunisia and South Africa.Patent applications in Morocco increased fast with an average annual growth of 7.3%.The increase in patent applications is due to improved research infrastructure and enhanced research activities,which shows the importance of biopharmaceutical innovation in the continent.展开更多
In recent years,biopharmaceuticals have witnessed remarkable advancements,transforming the landscape of therapeutic interventions.Biopharmaceuticals encompassing therapeutics generated through cutting-edge biotechnolo...In recent years,biopharmaceuticals have witnessed remarkable advancements,transforming the landscape of therapeutic interventions.Biopharmaceuticals encompassing therapeutics generated through cutting-edge biotechnological methods have shown promising therapeutic outcomes.However,their clinical success hinges significantly on overcoming drug delivery challenges related to stability,intracellular delivery,immunogenicity,and pharmacokinetic properties.Herein,we provide an overview of various marketed macromolecules,including nucleic acids,and immunotherapeutic agents such as cytokines and monoclonal antibodies,as well as other therapeutic peptides/proteins like enzymes,hormones,and coagulation factors.Our primary focus is on elucidating the delivery challenges associated with these macromolecules and highlighting the pivotal role played by drug delivery platforms in the development of currently marketed products,offering valuable insights for both scientific research and the pharmaceutical industry.展开更多
BACKGROUND Knee osteoarthritis(KOA)is a leading cause of arthritis-related morbidity.Mesenchymal stem cells(MSCs),as living biopharmaceuticals,have emerged as a potential treatment option due to their anti-inflammator...BACKGROUND Knee osteoarthritis(KOA)is a leading cause of arthritis-related morbidity.Mesenchymal stem cells(MSCs),as living biopharmaceuticals,have emerged as a potential treatment option due to their anti-inflammatory and immunomodulatory properties.AIM To compare the safety and efficacy of allogenic MSCs(^(Allo)MSCs)vs autologous MSCs(^(Auto)MSCs)in treating KOA in clinical settings.METHODS We conducted a systematic review and network meta-analysis to compare the safety and efficacy of^(Allo)MSCs vs^(Auto)MSCs in treating KOA.Our systematic search of four databases,including PubMed,Cochrane,Embase,and ClinicalTrials.gov,identified relevant randomized controlled trials(RCTs)reporting MSC-based treatment for KOA and reporting visual analog scale,Western Ontario and McMaster Universities Osteoarthritis scores,and adverse events.We assessed the methodological quality of the studies using the Cochrane Collaboration tool and calculated risk ratios(RRs)and weighted mean differences[with 95%confidence intervals(CIs)].Our statistical analyses used the R-Studio network meta-packages(version 2023.12.0).The study protocol was pre-registered on the International Prospective Register of Systematic Reviews(ID:CRD42024590866).RESULTS Nineteen RCTs involving 1216 patients with KOA met the inclusion criteria of the study.The network metaanalysis showed that^(Allo)MSCs gave a significant re-duction in visual analog scale scores by 14.91 points(95%CI:-24.52 to-5.30)vs 12.95 points with^(Auto)MSCs(95%CI:-24.42 to-1.48).For Western Ontario and McMaster Universities Osteoarthritis score,^(Allo)MSCs led to a significant reduction of 23.12 points(95%CI:-31.15 to-15.10)compared with 12.45 points using^(Auto)MSCs(95%CI:-19.31 to-5.59),thus revealing a significant improvement with^(Allo)MSCs(weighted mean difference:-10.62,95%CI:-21.23 to-0.11).Additionally,^(Auto)MSCs treatment showed a higher risk of joint-related adverse events(RR=1.39,95%CI:1.07-1.79)compared with^(Allo)MSCs(RR=1.13,95%CI:1.01-1.25).CONCLUSION^(Allo)MSCs may offer superior clinical outcomes with a lower risk of adverse events compared with^(Auto)MSCs in the treatment of KOA.However,the need for further RCTs directly comparing the two MSC types is crucial to validate this data,underscoring the importance of our findings in this field.展开更多
The biopharmaceutical industry contributes substantially to volatile organic compounds(VOCs)emissions,causing growing concerns and social developmental conflicts.This study conducted an on-site investigation of the pr...The biopharmaceutical industry contributes substantially to volatile organic compounds(VOCs)emissions,causing growing concerns and social developmental conflicts.This study conducted an on-site investigation of the process-based emission of VOCs from three biopharmaceutical enterprises.In the workshops of the three enterprises,26 VOCs were detected,which could be sorted into 4 classes:hydrocarbons,aromatic hydrocarbons,oxygen-containing compounds,and nitrogen-containing compounds.Ketones were the main components of waste gases,accounting for 44.13%-77.85%of the overall VOCs.Process-based source profiles were compiled for each process unit,with the fermentation and extraction units of tiamulin fumarate being the main source of VOC emissions.Dimethyl heptanone,vinyl acetate,diethylamine,propylene glycol methyl ether(PGME),and benzene were screened as priority pollutants through a fuzzy comprehensive evaluation system.Ground level concentration simulation results of the Gauss plume diffusion model demonstrated that the diffusivity of VOCs in the atmosphere was relatively high,indicating potential non-carcinogenic and carcinogenic risks 1.5-2 km downwind.Furthermore,the process-based formation potentials of ozone and secondary organic aerosols(SOAs)were determined and indicated that N-methyl-2-pyrrolidone,dimethyl heptanone,and PGME should be preferentially controlled to reduce the ozone formation potential,whereas the control of benzene and chlorobenzene should be prioritized to reduce the generation of SOAs.Our results provide a basis for understanding the characteristics of VOC emission by biopharmaceutical industries and their diffusion,potentially allowing the development of measures to reduce health risks and secondary pollution.展开更多
The biopharmaceutical sector is of considerable interest during the COVID-19 pandemic.This study aims to investigate the biopharmaceutical sector using the Shenwan Industry Classification and provides insights into in...The biopharmaceutical sector is of considerable interest during the COVID-19 pandemic.This study aims to investigate the biopharmaceutical sector using the Shenwan Industry Classification and provides insights into investment strategies.We combine factor and cluster analyses to reduce data dimensions and detect their latent similarities.Specifically,the biopharmaceutical sector is divided into six categories based on second-level industry classification.It is observed that medical devices,medical services,biological products,and chemical pharmaceuticals maintained their upward tendency,while Chinese medicine and pharmaceutical commerce declined slightly.We also develop optimal investment strategies using various metrics for different investor types.展开更多
Biopharmaceuticals,such as proteins,peptides,nucleic acids and vaccines,bring about great hopes for the prevention and treatment of various diseases,but the industrialization of these products still faces challenges s...Biopharmaceuticals,such as proteins,peptides,nucleic acids and vaccines,bring about great hopes for the prevention and treatment of various diseases,but the industrialization of these products still faces challenges such as structural instability,inefficient bioactivity and low bioavailability.Ionic liquids(ILs),the marvelous solvent media with inimitable and tunable properties,may provide alternative solutions to overcome the above problems of biopharmaceutical industry.Progress has gradually been made through studies by combination of ILs with biomacromolecules.The applications involved the stabilization,protection,and delivery of biopharmaceuticals.Recent trends are being forwarded to using ILs in vaccines and nucleic acid drugs.However,challenges remain on the toxicity and safety issues.Besides,the cost of adding ILs to the benefits of biopharmaceuticals need to be considered.展开更多
The COVID-19 epidemic caused by SARS-CoV-2 virus has turned into a worldwide pandemic.Therefore,health officials all around the world have strived for developing efficient preventive and treatment methods to deal with...The COVID-19 epidemic caused by SARS-CoV-2 virus has turned into a worldwide pandemic.Therefore,health officials all around the world have strived for developing efficient preventive and treatment methods to deal with this global crisis.Amongst them,monoclonal antibodies,anti-TNFs,and convalescent plasma appear to be effective against this disease.In addition,clinical trials are currently being conducted for viral targeting vaccines.This review summarizes major advances using biopharmaceuticals in the treatment and prevention strategies against COVID-19 that have occurred in the global medicinal system from its introduction until March 2022.展开更多
The marine biopharmaceutical industry(MBI)has been considered as an important part of the blue economy.The high-quality development of this industry depends on the high-level coordinated development of technological i...The marine biopharmaceutical industry(MBI)has been considered as an important part of the blue economy.The high-quality development of this industry depends on the high-level coordinated development of technological innovation system(TIS).In the present study,the coupling mechanism of industrial innovation input subsystem and innovation output subsystem was analyzed for the first time.On this basis,the development level and coupling coordination level of TIS in China’s MBI during 2008-2018 were empirically evaluated with the capacity coupling coordination model.Then,the obstacle factors were diagnosed and recognized with the obstacle model.The results showed that the innovation input index fluctuated at a low level in China’s MBI.The innovation output index has basically maintained a growth trend,whereas the quality of development was not high.Although the coupling coordination level of TIS showed a positive change as mild disordered→primary coordinated→well-coordinated,the development type of innovation system has changed from the lagging output of innovation into the lagging input of innovation.Insufficient input of innovation factors remained the main obstacle to the improvement of coordination level.Based on the above analysis,suggestions were put forward from the perspectives of policy and fund guarantees to improve the coupling coordination level in China’s MBI.展开更多
Biopharmaceutical discipline is an interdisciplinary subject with strong comprehensiveness and wide coverage. Under the background of credit system,it is an important task for application-oriented undergraduate colleg...Biopharmaceutical discipline is an interdisciplinary subject with strong comprehensiveness and wide coverage. Under the background of credit system,it is an important task for application-oriented undergraduate colleges and universities to optimize the cultivation program for innovative and entrepreneurial bio-pharmaceutical professionals. According to the characteristics of biopharmaceutical discipline,Binzhou University biopharmaceutical teaching and research office,based on the social demand for biopharmaceutical discipline talents,defined the principle of optimizing the cultivation of innovative and entrepreneurial biopharmaceutical discipline talents,and constructed the cultivation program of innovative and entrepreneurial biopharmaceutical discipline talents under the credit system. The development of this cultivation program is expected to build a new mode for cultivating high-level biopharmaceutical professionals with strong innovative spirit and entrepreneurial potential.展开更多
By using the methods of literature analysis,field investigation,exploration and research,experience summary,comparative inductive analysis,etc.,through the search of the latest literature and policy materials,producti...By using the methods of literature analysis,field investigation,exploration and research,experience summary,comparative inductive analysis,etc.,through the search of the latest literature and policy materials,production enterprises and domestic application-based undergraduate universities with related majors have been investigated on the spot.By analyzing the failed cases and drawing lessons from the successful experience,this paper explores the transformation and practical construction of the biopharmaceutical training base in application-based colleges and universities.This paper innovates and designs a new construction mode of biopharmaceutical training base in application-based universities,which provides reliable experience and valuable research results for the construction or transformation of biopharmaceutical training base in application-based colleges and universities.It has a very important potential value for promoting the social and economic benefits.展开更多
In recent years, people's health awareness has been gradually increased, which also places more emphasis on the aspects of medicine and health care, and also brings certain challenges to the biopharmaceutical indu...In recent years, people's health awareness has been gradually increased, which also places more emphasis on the aspects of medicine and health care, and also brings certain challenges to the biopharmaceutical industry. Especially since China's reform and opening up, the market demand has been expanding and more foreign drugs have been imported into our country. This has also increased the competitiveness of domestic drugs. After foreign drugs enter the country, if our pharmaceutical enterprises want to ensure their market position, they should strengthen the management of drug production costs and reduce drug prices. In the process of cost control, biopharmaceutical enterprises should adopt reasonable methods, which can not only make full use of enterprise resources but also control the cost to maximize the competitiveness of enterprises in the market. Therefore, it is necessary to analyze the problems in the cost control of the biopharmaceutical enterprises and find out the corresponding measures to ensure the healthy and stable development of the biopharmaceutical enterprises.展开更多
Objective To provide suggestions for supporting the key innovation subjects in Liaoning biopharmaceutical industry and selecting high quality cooperation partners from other provinces and cities.Methods Through statis...Objective To provide suggestions for supporting the key innovation subjects in Liaoning biopharmaceutical industry and selecting high quality cooperation partners from other provinces and cities.Methods Through statistical analysis of the invention patent data of biological pharmaceutical industry in Liaoning Province and other provinces,Excel was used to draw charts and to identify technical opportunities and other provinces.Then the innovation subjects in Liaoning Province and other provinces were studied separately to realize these opportunities.That is,the high quality partners from other provinces were selected for key innovative subjects in Liaoning Province.Results and Conclusion The key innovation subjects in the core technology field of Liaoning biopharmaceutical industry are Shenyang Agricultural University and Dalian University of Technology,which can be supported by emphasis.Their high quality partners in Beijing,Jiangsu Province and Guangdong Province are China Agricultural University,Jiangnan University and South China Agricultural University respectively.展开更多
Objective To study the influencing factors on the development of biopharmaceutical park,and to construct an evaluation model of the influencing factors for biopharmaceutical park in China.Methods By analyzing various ...Objective To study the influencing factors on the development of biopharmaceutical park,and to construct an evaluation model of the influencing factors for biopharmaceutical park in China.Methods By analyzing various factors affecting biopharmaceutical parks,an evaluation index system of biopharmaceutical parks and an evaluation model of influencing factors of biopharmaceutical park development based on fuzzy group decision making were established.Results and Conclusion Factors such as research and development(R&D)funding investment,incentive for transformation of scientific and technological achievements,and industrial clusters have a greater impact on the development of biopharmaceutical industrial parks in China.Local governments should increase the investment in R&D funding.Besides,they should pay attention to the incentive of transformation of scientific and technological achievements to improve the innovation ability of enterprises.Meanwhile,they should promote the clustering of high-tech enterprises to comprehensively enhance the healthy development of biopharmaceutical parks in China.展开更多
Enterprise cost management is an important means for an enterprise to enhance its core competitiveness and meet its strategic development needs. At present, biopharmaceutical enterprises have many problems in product ...Enterprise cost management is an important means for an enterprise to enhance its core competitiveness and meet its strategic development needs. At present, biopharmaceutical enterprises have many problems in product research and development, raw material procurement, quality cost and other aspects, which hinder enterprises to improve the efficiency of cost management and enterprise development. Therefore, biopharmaceutical enterprises should strengthen cost control, reduce the cost of each link and reduce economic losses;In addition, the enterprise should also pay attention to the quality cost control, reduce the cost while ensuring the high quality of the products, and help the enterprise to achieve the goal of cost reduction and efficiency improvement.展开更多
In recent years, the continuous development of social economy has continuously raised the level of science and technology. At the same time, the pharmaceutical technology of pharmaceutical enterprises has also undergo...In recent years, the continuous development of social economy has continuously raised the level of science and technology. At the same time, the pharmaceutical technology of pharmaceutical enterprises has also undergone significant changes. The application of biopharmaceutical technology in pharmaceutical technology has shown obvious and unique advantages. This has created a new pattern of modern pharmaceutical technology, which has been gradually recognized by the pharmaceutical industry, health care industry and daily chemical industry, and has become the key driving force for the production of new technologies and processes in the current era of science and technology. In this paper, research and analysis are carried out to explore the specific application direction and thinking of biopharmaceutical technology in pharmaceutical process, hoping to provide reference information for further research.展开更多
Objective To study the patent map and the relevant theories of the patent development of biopharmaceutical industry for conducting a comprehensive and in-depth analysis of the problems in patent application in Liaonin...Objective To study the patent map and the relevant theories of the patent development of biopharmaceutical industry for conducting a comprehensive and in-depth analysis of the problems in patent application in Liaoning biopharmaceutical industry.Methods Literature review,information visualization method,empirical analysis method and comparative analysis method were used to research the problems in the patent application.Results and Conclusion While developing biopharmaceutical industry,Liaoning provincial government should strengthen the protection of pharmaceutical patents,creating a new R&D mode of“university+research institutes+enterprises+individuals”to broaden the scope of technical fields.Then,its biopharmaceutical industry will be developed in an all-round way.Besides,it should closely follow the national development direction so that the biopharmaceutical industry in Liaoning Province will have a bright future.展开更多
Objective To systematically analyze the current development status of biopharmaceutical industrial park in China,sort out the problems and put forward some countermeasures and suggestions.Methods Relevant literature w...Objective To systematically analyze the current development status of biopharmaceutical industrial park in China,sort out the problems and put forward some countermeasures and suggestions.Methods Relevant literature was searched and reviewed to find out the problems faced by the development of biopharmaceutical industrial parks in China.Results and Conclusion Biopharmaceutical industrial parks are developing rapidly due to their unique industrial clustering advantages,but there are problems such as lack of overall planning at the top level,insufficient government support,imperfect talent support services and weak innovation capacity of the parks.It is recommended to promote the rapid development of biopharmaceutical industrial parks and biopharmaceutical enterprises by strengthening top-level design,increasing government support,focusing on talent introduction,and enhancing the innovative strength of the parks.展开更多
This paper estimates and decomposes the output-oriented three-stage cost Malmquist productivity index of the Taiwan region of China biotech and biopharmaceutical(B&BP)industry in 2004-2007 periods.The empirical es...This paper estimates and decomposes the output-oriented three-stage cost Malmquist productivity index of the Taiwan region of China biotech and biopharmaceutical(B&BP)industry in 2004-2007 periods.The empirical estimations proceed in three stages.Following the methodology of Yang and Huang(2009)with the assumption of variable return to scale(VRS)in the first stage,the original cost Malmquist productivity index(CM)is decomposed into five sources of productivity change:pure technical efficiency change,technical change,allocative efficiency change(AEC),input-price effect,and cost scale efficiency change.The method of Yang and Huang(2009)is an excellent contribution,but it did not deal with the exogenous environmental variables and noises.In the second stage,the original input variables are adjusted by the exogenous environmental variables.Finally,adjusted input variables produced by the second stage are reused for obtaining the reality of CM in the third stage.展开更多
Yeast-based models have become a powerful platform in pharmaceutical research,offering significant potential for producing complex drugs,vaccines,and therapeutic agents.While many current drugs were discovered before ...Yeast-based models have become a powerful platform in pharmaceutical research,offering significant potential for producing complex drugs,vaccines,and therapeutic agents.While many current drugs were discovered before fully understanding their molecular mechanisms,yeast systems now provide valuable insights for drug discovery and personalized medicine.Recent advancements in genetic engineering,metabolic engineering,and synthetic biology have improved the efficiency and scalability of yeast-based production systems,enabling more sustainable and cost-effective manufacturing processes.This paper reviews the latest developments in yeast-based technologies,focusing on their use as model organisms to study disease mechanisms,identify drug targets,and develop novel therapies.We highlight key platforms such as the yeast two-hybrid system,surface display technologies,and optimized expression systems.Additionally,we explore the future integration of yeast engineering with artificial intelligence(AI),machine learning(ML),and advanced genome editing technologies like CRISPR/Cas9,which are expected to accelerate drug discovery and enable personalized therapies.Furthermore,yeast-based systems are increasingly employed in largescale drug production,vaccine development,and therapeutic protein expression,offering promising applications in clinical and industrial settings.This paper discusses the practical implications of these systems and their potential to revolutionize drug development,paving the way for safer,more effective therapies.展开更多
In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding ...In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance.Pharmaceutical specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered appropriately.Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria.Quality attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.展开更多
文摘Objective To explore the current state of biopharmaceutical innovation in Africa by analyzing patent data related to biopharmaceutical products in African countries.Methods Based on patent data,simple descriptive statistical methods were used to analyze the trend of patent applications,the geographical distribution of patents,and the distribution of applicants in the pharmaceutical field in Africa.Besides,Excel software was used to draw charts to visualize statistical information.Results and Conclusion According to the result,a large number of patents has been granted in these countries and the number is steadily rising each year.From the figure below,we can see that the largest number of patents was granted to Morocco in 2014 with a total number of 613 patents followed by Tunisia with 315 patents,the African Intellectual Property Organization(OAPI)with 124 patents,South Africa with 106 and Mozambique with 1 patent based on data availability(IncoPat Global Patent Search Database).It was observed that,as patents were granted,the number of applications filed on this continent increased.The largest number of patents has been recorded by Morocco,Tunisia and South Africa.Patent applications in Morocco increased fast with an average annual growth of 7.3%.The increase in patent applications is due to improved research infrastructure and enhanced research activities,which shows the importance of biopharmaceutical innovation in the continent.
基金supported by the National Natural Science Foundation of China(Nos.82073782 and 82241002)the Natural Science Foundation of the Jiangsu Higher Education Institutions of China(No.21KJA320003)the Scientific Research Project of Jiangsu Commission of Health(No.LKZ2023001)。
文摘In recent years,biopharmaceuticals have witnessed remarkable advancements,transforming the landscape of therapeutic interventions.Biopharmaceuticals encompassing therapeutics generated through cutting-edge biotechnological methods have shown promising therapeutic outcomes.However,their clinical success hinges significantly on overcoming drug delivery challenges related to stability,intracellular delivery,immunogenicity,and pharmacokinetic properties.Herein,we provide an overview of various marketed macromolecules,including nucleic acids,and immunotherapeutic agents such as cytokines and monoclonal antibodies,as well as other therapeutic peptides/proteins like enzymes,hormones,and coagulation factors.Our primary focus is on elucidating the delivery challenges associated with these macromolecules and highlighting the pivotal role played by drug delivery platforms in the development of currently marketed products,offering valuable insights for both scientific research and the pharmaceutical industry.
文摘BACKGROUND Knee osteoarthritis(KOA)is a leading cause of arthritis-related morbidity.Mesenchymal stem cells(MSCs),as living biopharmaceuticals,have emerged as a potential treatment option due to their anti-inflammatory and immunomodulatory properties.AIM To compare the safety and efficacy of allogenic MSCs(^(Allo)MSCs)vs autologous MSCs(^(Auto)MSCs)in treating KOA in clinical settings.METHODS We conducted a systematic review and network meta-analysis to compare the safety and efficacy of^(Allo)MSCs vs^(Auto)MSCs in treating KOA.Our systematic search of four databases,including PubMed,Cochrane,Embase,and ClinicalTrials.gov,identified relevant randomized controlled trials(RCTs)reporting MSC-based treatment for KOA and reporting visual analog scale,Western Ontario and McMaster Universities Osteoarthritis scores,and adverse events.We assessed the methodological quality of the studies using the Cochrane Collaboration tool and calculated risk ratios(RRs)and weighted mean differences[with 95%confidence intervals(CIs)].Our statistical analyses used the R-Studio network meta-packages(version 2023.12.0).The study protocol was pre-registered on the International Prospective Register of Systematic Reviews(ID:CRD42024590866).RESULTS Nineteen RCTs involving 1216 patients with KOA met the inclusion criteria of the study.The network metaanalysis showed that^(Allo)MSCs gave a significant re-duction in visual analog scale scores by 14.91 points(95%CI:-24.52 to-5.30)vs 12.95 points with^(Auto)MSCs(95%CI:-24.42 to-1.48).For Western Ontario and McMaster Universities Osteoarthritis score,^(Allo)MSCs led to a significant reduction of 23.12 points(95%CI:-31.15 to-15.10)compared with 12.45 points using^(Auto)MSCs(95%CI:-19.31 to-5.59),thus revealing a significant improvement with^(Allo)MSCs(weighted mean difference:-10.62,95%CI:-21.23 to-0.11).Additionally,^(Auto)MSCs treatment showed a higher risk of joint-related adverse events(RR=1.39,95%CI:1.07-1.79)compared with^(Allo)MSCs(RR=1.13,95%CI:1.01-1.25).CONCLUSION^(Allo)MSCs may offer superior clinical outcomes with a lower risk of adverse events compared with^(Auto)MSCs in the treatment of KOA.However,the need for further RCTs directly comparing the two MSC types is crucial to validate this data,underscoring the importance of our findings in this field.
基金financially supported by the National Natural Science Foundation of China (No.51878650)。
文摘The biopharmaceutical industry contributes substantially to volatile organic compounds(VOCs)emissions,causing growing concerns and social developmental conflicts.This study conducted an on-site investigation of the process-based emission of VOCs from three biopharmaceutical enterprises.In the workshops of the three enterprises,26 VOCs were detected,which could be sorted into 4 classes:hydrocarbons,aromatic hydrocarbons,oxygen-containing compounds,and nitrogen-containing compounds.Ketones were the main components of waste gases,accounting for 44.13%-77.85%of the overall VOCs.Process-based source profiles were compiled for each process unit,with the fermentation and extraction units of tiamulin fumarate being the main source of VOC emissions.Dimethyl heptanone,vinyl acetate,diethylamine,propylene glycol methyl ether(PGME),and benzene were screened as priority pollutants through a fuzzy comprehensive evaluation system.Ground level concentration simulation results of the Gauss plume diffusion model demonstrated that the diffusivity of VOCs in the atmosphere was relatively high,indicating potential non-carcinogenic and carcinogenic risks 1.5-2 km downwind.Furthermore,the process-based formation potentials of ozone and secondary organic aerosols(SOAs)were determined and indicated that N-methyl-2-pyrrolidone,dimethyl heptanone,and PGME should be preferentially controlled to reduce the ozone formation potential,whereas the control of benzene and chlorobenzene should be prioritized to reduce the generation of SOAs.Our results provide a basis for understanding the characteristics of VOC emission by biopharmaceutical industries and their diffusion,potentially allowing the development of measures to reduce health risks and secondary pollution.
基金XJTLU Postgraduate Research Scholarship-PGRS2012016.
文摘The biopharmaceutical sector is of considerable interest during the COVID-19 pandemic.This study aims to investigate the biopharmaceutical sector using the Shenwan Industry Classification and provides insights into investment strategies.We combine factor and cluster analyses to reduce data dimensions and detect their latent similarities.Specifically,the biopharmaceutical sector is divided into six categories based on second-level industry classification.It is observed that medical devices,medical services,biological products,and chemical pharmaceuticals maintained their upward tendency,while Chinese medicine and pharmaceutical commerce declined slightly.We also develop optimal investment strategies using various metrics for different investor types.
基金The authors are thankful for the financial support from the National Natural Science Foundation of China(Nos.21808226,31970872,and 21821005).
文摘Biopharmaceuticals,such as proteins,peptides,nucleic acids and vaccines,bring about great hopes for the prevention and treatment of various diseases,but the industrialization of these products still faces challenges such as structural instability,inefficient bioactivity and low bioavailability.Ionic liquids(ILs),the marvelous solvent media with inimitable and tunable properties,may provide alternative solutions to overcome the above problems of biopharmaceutical industry.Progress has gradually been made through studies by combination of ILs with biomacromolecules.The applications involved the stabilization,protection,and delivery of biopharmaceuticals.Recent trends are being forwarded to using ILs in vaccines and nucleic acid drugs.However,challenges remain on the toxicity and safety issues.Besides,the cost of adding ILs to the benefits of biopharmaceuticals need to be considered.
基金financial support from the Food and Drug Safety Research Center at Tabriz University of Medical Sciences(Grant No.66317).
文摘The COVID-19 epidemic caused by SARS-CoV-2 virus has turned into a worldwide pandemic.Therefore,health officials all around the world have strived for developing efficient preventive and treatment methods to deal with this global crisis.Amongst them,monoclonal antibodies,anti-TNFs,and convalescent plasma appear to be effective against this disease.In addition,clinical trials are currently being conducted for viral targeting vaccines.This review summarizes major advances using biopharmaceuticals in the treatment and prevention strategies against COVID-19 that have occurred in the global medicinal system from its introduction until March 2022.
基金supported by the National Natural Science Foundation of China(Nos.42176126,42076221)the Department of Marine Strategic Planning and Economy,Ministry of Natural Resources of China,and Marine Development Research Society of China(No.CAMA201817).
文摘The marine biopharmaceutical industry(MBI)has been considered as an important part of the blue economy.The high-quality development of this industry depends on the high-level coordinated development of technological innovation system(TIS).In the present study,the coupling mechanism of industrial innovation input subsystem and innovation output subsystem was analyzed for the first time.On this basis,the development level and coupling coordination level of TIS in China’s MBI during 2008-2018 were empirically evaluated with the capacity coupling coordination model.Then,the obstacle factors were diagnosed and recognized with the obstacle model.The results showed that the innovation input index fluctuated at a low level in China’s MBI.The innovation output index has basically maintained a growth trend,whereas the quality of development was not high.Although the coupling coordination level of TIS showed a positive change as mild disordered→primary coordinated→well-coordinated,the development type of innovation system has changed from the lagging output of innovation into the lagging input of innovation.Insufficient input of innovation factors remained the main obstacle to the improvement of coordination level.Based on the above analysis,suggestions were put forward from the perspectives of policy and fund guarantees to improve the coupling coordination level in China’s MBI.
基金Supported by the Project of the University-level Teaching Reform of Binzhou University in 2017[BYJYYB201736]the School-enterprise Co-construction Course Project of Binzhou University in 2017[BYXQGJ201706]+2 种基金the Natural Science Foundation of Shandong Province[ZR2019MH054]Doctor Foundation of Binzhou University[2016Y17&2016Y02]the Project of Shandong Province Higher Educational Science and Technology Program of China[J17KA120]
文摘Biopharmaceutical discipline is an interdisciplinary subject with strong comprehensiveness and wide coverage. Under the background of credit system,it is an important task for application-oriented undergraduate colleges and universities to optimize the cultivation program for innovative and entrepreneurial bio-pharmaceutical professionals. According to the characteristics of biopharmaceutical discipline,Binzhou University biopharmaceutical teaching and research office,based on the social demand for biopharmaceutical discipline talents,defined the principle of optimizing the cultivation of innovative and entrepreneurial biopharmaceutical discipline talents,and constructed the cultivation program of innovative and entrepreneurial biopharmaceutical discipline talents under the credit system. The development of this cultivation program is expected to build a new mode for cultivating high-level biopharmaceutical professionals with strong innovative spirit and entrepreneurial potential.
基金2020 New Engineering Research and Reform Practice Project in Fujian Province[(MinJiaoGao(2020)4-59)]Research Project on General Education and Teaching Reform of Universities in Fujian Province(FBJG20190201,FBJG20200178)+1 种基金the 13 th Five-Year Plan of Education and Science in Xiamen City(1926)Education and Teaching Reform Research Project of Xiamen Medical College(XBGL2019002,XBJG2020002,XBGL2019003,XBGL2019005).
文摘By using the methods of literature analysis,field investigation,exploration and research,experience summary,comparative inductive analysis,etc.,through the search of the latest literature and policy materials,production enterprises and domestic application-based undergraduate universities with related majors have been investigated on the spot.By analyzing the failed cases and drawing lessons from the successful experience,this paper explores the transformation and practical construction of the biopharmaceutical training base in application-based colleges and universities.This paper innovates and designs a new construction mode of biopharmaceutical training base in application-based universities,which provides reliable experience and valuable research results for the construction or transformation of biopharmaceutical training base in application-based colleges and universities.It has a very important potential value for promoting the social and economic benefits.
文摘In recent years, people's health awareness has been gradually increased, which also places more emphasis on the aspects of medicine and health care, and also brings certain challenges to the biopharmaceutical industry. Especially since China's reform and opening up, the market demand has been expanding and more foreign drugs have been imported into our country. This has also increased the competitiveness of domestic drugs. After foreign drugs enter the country, if our pharmaceutical enterprises want to ensure their market position, they should strengthen the management of drug production costs and reduce drug prices. In the process of cost control, biopharmaceutical enterprises should adopt reasonable methods, which can not only make full use of enterprise resources but also control the cost to maximize the competitiveness of enterprises in the market. Therefore, it is necessary to analyze the problems in the cost control of the biopharmaceutical enterprises and find out the corresponding measures to ensure the healthy and stable development of the biopharmaceutical enterprises.
基金Science and Technology Plan Project of Liaoning Province:“Transformation and Protection of Scientific and Technological Achievements”[2017401021].
文摘Objective To provide suggestions for supporting the key innovation subjects in Liaoning biopharmaceutical industry and selecting high quality cooperation partners from other provinces and cities.Methods Through statistical analysis of the invention patent data of biological pharmaceutical industry in Liaoning Province and other provinces,Excel was used to draw charts and to identify technical opportunities and other provinces.Then the innovation subjects in Liaoning Province and other provinces were studied separately to realize these opportunities.That is,the high quality partners from other provinces were selected for key innovative subjects in Liaoning Province.Results and Conclusion The key innovation subjects in the core technology field of Liaoning biopharmaceutical industry are Shenyang Agricultural University and Dalian University of Technology,which can be supported by emphasis.Their high quality partners in Beijing,Jiangsu Province and Guangdong Province are China Agricultural University,Jiangnan University and South China Agricultural University respectively.
文摘Objective To study the influencing factors on the development of biopharmaceutical park,and to construct an evaluation model of the influencing factors for biopharmaceutical park in China.Methods By analyzing various factors affecting biopharmaceutical parks,an evaluation index system of biopharmaceutical parks and an evaluation model of influencing factors of biopharmaceutical park development based on fuzzy group decision making were established.Results and Conclusion Factors such as research and development(R&D)funding investment,incentive for transformation of scientific and technological achievements,and industrial clusters have a greater impact on the development of biopharmaceutical industrial parks in China.Local governments should increase the investment in R&D funding.Besides,they should pay attention to the incentive of transformation of scientific and technological achievements to improve the innovation ability of enterprises.Meanwhile,they should promote the clustering of high-tech enterprises to comprehensively enhance the healthy development of biopharmaceutical parks in China.
文摘Enterprise cost management is an important means for an enterprise to enhance its core competitiveness and meet its strategic development needs. At present, biopharmaceutical enterprises have many problems in product research and development, raw material procurement, quality cost and other aspects, which hinder enterprises to improve the efficiency of cost management and enterprise development. Therefore, biopharmaceutical enterprises should strengthen cost control, reduce the cost of each link and reduce economic losses;In addition, the enterprise should also pay attention to the quality cost control, reduce the cost while ensuring the high quality of the products, and help the enterprise to achieve the goal of cost reduction and efficiency improvement.
文摘In recent years, the continuous development of social economy has continuously raised the level of science and technology. At the same time, the pharmaceutical technology of pharmaceutical enterprises has also undergone significant changes. The application of biopharmaceutical technology in pharmaceutical technology has shown obvious and unique advantages. This has created a new pattern of modern pharmaceutical technology, which has been gradually recognized by the pharmaceutical industry, health care industry and daily chemical industry, and has become the key driving force for the production of new technologies and processes in the current era of science and technology. In this paper, research and analysis are carried out to explore the specific application direction and thinking of biopharmaceutical technology in pharmaceutical process, hoping to provide reference information for further research.
文摘Objective To study the patent map and the relevant theories of the patent development of biopharmaceutical industry for conducting a comprehensive and in-depth analysis of the problems in patent application in Liaoning biopharmaceutical industry.Methods Literature review,information visualization method,empirical analysis method and comparative analysis method were used to research the problems in the patent application.Results and Conclusion While developing biopharmaceutical industry,Liaoning provincial government should strengthen the protection of pharmaceutical patents,creating a new R&D mode of“university+research institutes+enterprises+individuals”to broaden the scope of technical fields.Then,its biopharmaceutical industry will be developed in an all-round way.Besides,it should closely follow the national development direction so that the biopharmaceutical industry in Liaoning Province will have a bright future.
文摘Objective To systematically analyze the current development status of biopharmaceutical industrial park in China,sort out the problems and put forward some countermeasures and suggestions.Methods Relevant literature was searched and reviewed to find out the problems faced by the development of biopharmaceutical industrial parks in China.Results and Conclusion Biopharmaceutical industrial parks are developing rapidly due to their unique industrial clustering advantages,but there are problems such as lack of overall planning at the top level,insufficient government support,imperfect talent support services and weak innovation capacity of the parks.It is recommended to promote the rapid development of biopharmaceutical industrial parks and biopharmaceutical enterprises by strengthening top-level design,increasing government support,focusing on talent introduction,and enhancing the innovative strength of the parks.
文摘This paper estimates and decomposes the output-oriented three-stage cost Malmquist productivity index of the Taiwan region of China biotech and biopharmaceutical(B&BP)industry in 2004-2007 periods.The empirical estimations proceed in three stages.Following the methodology of Yang and Huang(2009)with the assumption of variable return to scale(VRS)in the first stage,the original cost Malmquist productivity index(CM)is decomposed into five sources of productivity change:pure technical efficiency change,technical change,allocative efficiency change(AEC),input-price effect,and cost scale efficiency change.The method of Yang and Huang(2009)is an excellent contribution,but it did not deal with the exogenous environmental variables and noises.In the second stage,the original input variables are adjusted by the exogenous environmental variables.Finally,adjusted input variables produced by the second stage are reused for obtaining the reality of CM in the third stage.
基金funded by 2024 Scientific Research Project of Chongqing Medical and Pharmaceutical College(No.ygzrc2024101)Chongqing Education Commission Natural Science Foundation(No.KJQN202402821)+2 种基金Chongqing Shapingba District Science and Technology Bureau Project(No.2024071)2024 Chongqing Medical and Pharmaceutical College Innovation Research Group Project(No.ygz2024401)Chongqing Science and Health Joint Medical Research Project(No.2024SQKWLHMS051),respectively.
文摘Yeast-based models have become a powerful platform in pharmaceutical research,offering significant potential for producing complex drugs,vaccines,and therapeutic agents.While many current drugs were discovered before fully understanding their molecular mechanisms,yeast systems now provide valuable insights for drug discovery and personalized medicine.Recent advancements in genetic engineering,metabolic engineering,and synthetic biology have improved the efficiency and scalability of yeast-based production systems,enabling more sustainable and cost-effective manufacturing processes.This paper reviews the latest developments in yeast-based technologies,focusing on their use as model organisms to study disease mechanisms,identify drug targets,and develop novel therapies.We highlight key platforms such as the yeast two-hybrid system,surface display technologies,and optimized expression systems.Additionally,we explore the future integration of yeast engineering with artificial intelligence(AI),machine learning(ML),and advanced genome editing technologies like CRISPR/Cas9,which are expected to accelerate drug discovery and enable personalized therapies.Furthermore,yeast-based systems are increasingly employed in largescale drug production,vaccine development,and therapeutic protein expression,offering promising applications in clinical and industrial settings.This paper discusses the practical implications of these systems and their potential to revolutionize drug development,paving the way for safer,more effective therapies.
基金supported by the Grant for Development of New Faculty Staff,Ratchadaphiseksomphot Endowment Fund,Chula-longkorn University,Thailand(Grant No.:DNS64_047_33_003_1 to Patanachai K.Limpikirati)Grant for Development of New Scholar,Office of the Permanent Secretary,Ministry of Higher Ed-ucation,Science,Research and Innovation,Thailand(Grant No.:RGNS64_012 to Patanachai K.Limpikirati).
文摘In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance.Pharmaceutical specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered appropriately.Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria.Quality attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.
