Objective To analyze the development status of contract development manufacturing organization(CDMO)at home and abroad,and to make some suggestions for the development of CDMO in China.Methods The relevant literature ...Objective To analyze the development status of contract development manufacturing organization(CDMO)at home and abroad,and to make some suggestions for the development of CDMO in China.Methods The relevant literature was searched and reviewed,and the development status of CDMOs in the United States,France,Japan and China was compared from the aspects of market scale,development process,development focus,advantages and disadvantages,and policy support.Then,some suggestions for the development of CDMO enterprises in China were summarized.Results and Conclusion Through the comparison of CDMO development at home and abroad,it can be seen that China started CDMO late,there were many technical barriers and its globalization layout were not sufficient.However,the development trend was good and it focused on the field of chemical drugs and biological drugs to constantly develop innovative drugs.China needs to continuously improve its own technical capabilities to carry out innovative research.Therefore,cost reduction and efficiency increase will be the key elements for the development of CDMOs,and they are expected to have a rapid and comprehensive development in the future.展开更多
CDMOs are emerging as critical drivers of innovation within the pharmaceutical and biotech industries. As the pharmaceutical industry continues to evolve, we can expect to see CDMOs play an increasingly important role...CDMOs are emerging as critical drivers of innovation within the pharmaceutical and biotech industries. As the pharmaceutical industry continues to evolve, we can expect to see CDMOs play an increasingly important role in drug development and manufacturing. Many companies within these sectors are now leveraging the expertise of CDMOs through technology transfers to foster innovation and enhance the development of new drug products. In the extensive field of drug development, technology transfer plays a crucial role at multiple stages, ranging from preclinical phases to commercialization. By working closely with drug developers, CDMOs can ensure that technologies are transferred seamlessly between phases of drug development, allowing for a more efficient and cost-effective development process. CDMOs also bring a wealth of experience in various areas of drug development, including process development, analytical testing, quality control, and manufacturing. This expertise, combined with a focus on innovation, can help drug developers to overcome technical challenges and optimize their drug development programs. CDMOs can provide drug developers with various manufacturing capabilities, from small-scale clinical trials to large-scale commercial production. This flexibility allows drug developers to focus on their core competencies while relying on CDMOs to provide the necessary infrastructure and support for drug manufacturing. The critical role of CDMOs in advancing pharmaceutical innovation in phase-appropriate technology transfer where there will be a lot of effort and patience with strong technical expertise is required. This article explores the various types of Technology transfer from preclinical to commercial stages and successful strategies to foster innovation.展开更多
The synthesis of CDMO from LiOH and EMD has been investigated by thermogravimetry and pow- der X-ray diffraction analysis.The results showed that it took place from below 100 to 400℃.When the proportion of Li:Mn in t...The synthesis of CDMO from LiOH and EMD has been investigated by thermogravimetry and pow- der X-ray diffraction analysis.The results showed that it took place from below 100 to 400℃.When the proportion of Li:Mn in the starting mixture was 3:7,the measured weight loss during this process was 7.40% for heat-treated EMD and 8.33% for non-heat-treated EMD.Based on these data and X-ray diffraction results the obtained product would be 3LiMn204 - MnO2.This material was es- sentially amorphous.It can insert 4.7 Li per 3LiMn_2O_4·MnO_2,leading to a capacity of 170- 200 mAh/g and demonstrated reasonable discharge and recharge cycle performance for both test cells and practical batteries.展开更多
In the emerging world of biotech innovation, the fast-to-clinic/market strategy has emerged as a critical “mantra” for biotech, investors, and CDMOs. This approach addresses the escalating costs and complexities of ...In the emerging world of biotech innovation, the fast-to-clinic/market strategy has emerged as a critical “mantra” for biotech, investors, and CDMOs. This approach addresses the escalating costs and complexities of research and development by streamlining the path from concept to clinical trials and, ultimately, to market. The article delves into the intricacies of implementing a fast-to-clinic/market strategy, underlining the empowering role of strategic decision-making in preclinical and commercial stages. The plan advocates for a phase-appropriate approach, where the development decision is tailored to each phase of the product’s lifecycle. This ensures that resources are allocated efficiently, risks are managed effectively, and the product can move through the development pipeline accelerated without compromising quality or regulatory compliance. The article also discusses the role of CDMOs in facilitating rapid product development and the essential factors biotech companies must consider when selecting a partner for outsourcing. These factors include the CDMO’s expertise in navigating regulatory landscapes, technological capabilities, and ability to scale processes efficiently. Moreover, the article stresses the importance of agility and flexibility in the fast-to-clinic/market approach. Biotech companies are encouraged to adopt adaptable strategies that respond to the fast-evolving regulatory and market landscapes.展开更多
The scintillation properties of a CdMoO4 crystal have been investigated experimentally.The fluorescence yields and decay times measured from 22 K to 300 K demonstrate that CdMoO4 crystal is a good candidate for an abs...The scintillation properties of a CdMoO4 crystal have been investigated experimentally.The fluorescence yields and decay times measured from 22 K to 300 K demonstrate that CdMoO4 crystal is a good candidate for an absorber for a bolometer readout,for both heat and scintillation signals.The results from Monte Carlo studies,taking the backgrounds from 2ν2β of^100 42Mo ^116 48Cd） and internal trace nuclides ^214Bi and ^208Tl into account,show that the expected sensitivity of a CdMoO4 bolometer for neutrinoless double beta decay experiments with an exposure of 100kg·years is one order of magnitude higher than those of the current sets of the limT1/2^0νββ of ^100 42Mo and ^116 48Cd.展开更多
Antibody-drug conjugates (ADCs) are pioneering biologics that merge antibodies’ specificity with small molecules’ potency. With a handful of FDA-approved ADCs in the market and many under development, ADCs are poise...Antibody-drug conjugates (ADCs) are pioneering biologics that merge antibodies’ specificity with small molecules’ potency. With a handful of FDA-approved ADCs in the market and many under development, ADCs are poised to revolutionize therapeutics. This paper examines the complexities of ADC production, emphasizing the importance of process characterization and the pivotal role of supply chain characteristics, safety requirements, and Contract Manufacturing Organizations (CMOs) with proficiency. The swift transition of antibody-drug conjugate (ADC) programs from early to advanced clinical stages underscores the urgency for quick and efficient commercial launch preparation. This article delves into strategies to hasten commercial readiness, supply chain strategy, the significance of partnering with adept contract development and manufacturing organizations (CDMOs), and the challenges of ADC production.展开更多
文摘Objective To analyze the development status of contract development manufacturing organization(CDMO)at home and abroad,and to make some suggestions for the development of CDMO in China.Methods The relevant literature was searched and reviewed,and the development status of CDMOs in the United States,France,Japan and China was compared from the aspects of market scale,development process,development focus,advantages and disadvantages,and policy support.Then,some suggestions for the development of CDMO enterprises in China were summarized.Results and Conclusion Through the comparison of CDMO development at home and abroad,it can be seen that China started CDMO late,there were many technical barriers and its globalization layout were not sufficient.However,the development trend was good and it focused on the field of chemical drugs and biological drugs to constantly develop innovative drugs.China needs to continuously improve its own technical capabilities to carry out innovative research.Therefore,cost reduction and efficiency increase will be the key elements for the development of CDMOs,and they are expected to have a rapid and comprehensive development in the future.
文摘CDMOs are emerging as critical drivers of innovation within the pharmaceutical and biotech industries. As the pharmaceutical industry continues to evolve, we can expect to see CDMOs play an increasingly important role in drug development and manufacturing. Many companies within these sectors are now leveraging the expertise of CDMOs through technology transfers to foster innovation and enhance the development of new drug products. In the extensive field of drug development, technology transfer plays a crucial role at multiple stages, ranging from preclinical phases to commercialization. By working closely with drug developers, CDMOs can ensure that technologies are transferred seamlessly between phases of drug development, allowing for a more efficient and cost-effective development process. CDMOs also bring a wealth of experience in various areas of drug development, including process development, analytical testing, quality control, and manufacturing. This expertise, combined with a focus on innovation, can help drug developers to overcome technical challenges and optimize their drug development programs. CDMOs can provide drug developers with various manufacturing capabilities, from small-scale clinical trials to large-scale commercial production. This flexibility allows drug developers to focus on their core competencies while relying on CDMOs to provide the necessary infrastructure and support for drug manufacturing. The critical role of CDMOs in advancing pharmaceutical innovation in phase-appropriate technology transfer where there will be a lot of effort and patience with strong technical expertise is required. This article explores the various types of Technology transfer from preclinical to commercial stages and successful strategies to foster innovation.
文摘The synthesis of CDMO from LiOH and EMD has been investigated by thermogravimetry and pow- der X-ray diffraction analysis.The results showed that it took place from below 100 to 400℃.When the proportion of Li:Mn in the starting mixture was 3:7,the measured weight loss during this process was 7.40% for heat-treated EMD and 8.33% for non-heat-treated EMD.Based on these data and X-ray diffraction results the obtained product would be 3LiMn204 - MnO2.This material was es- sentially amorphous.It can insert 4.7 Li per 3LiMn_2O_4·MnO_2,leading to a capacity of 170- 200 mAh/g and demonstrated reasonable discharge and recharge cycle performance for both test cells and practical batteries.
文摘In the emerging world of biotech innovation, the fast-to-clinic/market strategy has emerged as a critical “mantra” for biotech, investors, and CDMOs. This approach addresses the escalating costs and complexities of research and development by streamlining the path from concept to clinical trials and, ultimately, to market. The article delves into the intricacies of implementing a fast-to-clinic/market strategy, underlining the empowering role of strategic decision-making in preclinical and commercial stages. The plan advocates for a phase-appropriate approach, where the development decision is tailored to each phase of the product’s lifecycle. This ensures that resources are allocated efficiently, risks are managed effectively, and the product can move through the development pipeline accelerated without compromising quality or regulatory compliance. The article also discusses the role of CDMOs in facilitating rapid product development and the essential factors biotech companies must consider when selecting a partner for outsourcing. These factors include the CDMO’s expertise in navigating regulatory landscapes, technological capabilities, and ability to scale processes efficiently. Moreover, the article stresses the importance of agility and flexibility in the fast-to-clinic/market approach. Biotech companies are encouraged to adopt adaptable strategies that respond to the fast-evolving regulatory and market landscapes.
基金Supported by National Natural Science Foundation of China(11275199)
文摘The scintillation properties of a CdMoO4 crystal have been investigated experimentally.The fluorescence yields and decay times measured from 22 K to 300 K demonstrate that CdMoO4 crystal is a good candidate for an absorber for a bolometer readout,for both heat and scintillation signals.The results from Monte Carlo studies,taking the backgrounds from 2ν2β of^100 42Mo ^116 48Cd） and internal trace nuclides ^214Bi and ^208Tl into account,show that the expected sensitivity of a CdMoO4 bolometer for neutrinoless double beta decay experiments with an exposure of 100kg·years is one order of magnitude higher than those of the current sets of the limT1/2^0νββ of ^100 42Mo and ^116 48Cd.
文摘Antibody-drug conjugates (ADCs) are pioneering biologics that merge antibodies’ specificity with small molecules’ potency. With a handful of FDA-approved ADCs in the market and many under development, ADCs are poised to revolutionize therapeutics. This paper examines the complexities of ADC production, emphasizing the importance of process characterization and the pivotal role of supply chain characteristics, safety requirements, and Contract Manufacturing Organizations (CMOs) with proficiency. The swift transition of antibody-drug conjugate (ADC) programs from early to advanced clinical stages underscores the urgency for quick and efficient commercial launch preparation. This article delves into strategies to hasten commercial readiness, supply chain strategy, the significance of partnering with adept contract development and manufacturing organizations (CDMOs), and the challenges of ADC production.
