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1.
Environ Sci Technol ; 58(15): 6616-6627, 2024 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-38569050

RESUMO

While the extent of environmental contamination by per- and polyfluoroalkyl substances (PFAS) has mobilized considerable efforts around the globe in recent years, publicly available data on PFAS in Europe were very limited. In an unprecedented experiment of "expert-reviewed journalism" involving 29 journalists and seven scientific advisers, a cross-border collaborative project, the "Forever Pollution Project" (FPP), drew on both scientific methods and investigative journalism techniques such as open-source intelligence (OSINT) and freedom of information (FOI) requests to map contamination across Europe, making public data that previously had existed as "unseen science". The FPP identified 22,934 known contamination sites, including 20 PFAS manufacturing facilities, and 21,426 "presumptive contamination sites", including 13,745 sites presumably contaminated with fluorinated aqueous film-forming foam (AFFF) discharge, 2911 industrial facilities, and 4752 sites related to PFAS-containing waste. Additionally, the FPP identified 231 "known PFAS users", a new category for sites with an intermediate level of evidence of PFAS use and considered likely to be contamination sources. However, the true extent of contamination in Europe remains significantly underestimated due to a lack of comprehensive geolocation, sampling, and publicly available data. This model of knowledge production and dissemination offers lessons for researchers, policymakers, and journalists about cross-field collaborations and data transparency.


Assuntos
Fluorocarbonos , Poluentes Químicos da Água , Fluorocarbonos/análise , Poluentes Químicos da Água/análise , Poluição Ambiental , Europa (Continente) , Comércio
3.
Zhongguo Zhong Yao Za Zhi ; 49(5): 1137-1143, 2024 Mar.
Artigo em Chinês | MEDLINE | ID: mdl-38621960

RESUMO

The protection, development, and utilization of medicinal plant resources are important cornerstones of maintaining human health. However, due to factors such as the reduction of high-quality land resources, deterioration of ecological environments, and excessive and disorderly resource development, medicinal plant resources are becoming scarce, and some of them are insufficiently supplied. With the proposal of "the Belt and Road" Initiative, the cooperation between China and "the Belt and Road" partners(the countries and regions involved in "the Belt and Road" Initiative)is increasingly close, which provides a new opportunity for carrying out trade of medicinal plant resources and alleviating the problem of imbalance and relative inadequacy of medicinal plant resources in countries. This study first determined the distribution and species information of plant resources in countries and regions involved in "the Belt and Road" Initiative by investigating the database of plant distribution and that of medicinal plant resources. Then, according to the published data from the International Union for Conservation of Nature(IUCN) and the Convention on International Trade in Endangered Species of Wild Fauna and Flora(CITES), this study identified the rare and endangered medicinal plants and the medicinal plants under trade control in countries and regions involved in "the Belt and Road" Initiative and finally sorted out the list of potential medicinal plant resources in countries and regions involved in "the Belt and Road" Initiative that can be used by China. This data resource can not only be used for the overall protection of important endangered species but also scientifically guide the development and utilization of medicinal resources, providing guidance and a theoretical basis for the sustainable development of medicinal plant resources in countries and regions involved in "the Belt and Road" Initiative.


Assuntos
Plantas Medicinais , Humanos , Animais , Comércio , Internacionalidade , Meio Ambiente , China , Espécies em Perigo de Extinção
4.
Zhongguo Zhong Yao Za Zhi ; 49(6): 1699-1704, 2024 Mar.
Artigo em Chinês | MEDLINE | ID: mdl-38621954

RESUMO

The quality of traditional Chinese medicine preparations is directly related to the safety of patients. Among the various factors, the process and corresponding critical equipment are critical factors influencing the quality of the preparations. To improve the quality of traditional Chinese medicine preparations, this article summarizes and analyzes the problems in the process links and corresponding critical equipment in the manufacturing process of traditional Chinese medicine preparations. Furthermore, a critical quality attribute evaluation system is established based on safety and effectiveness combined with the drug properties, preparation process, and preparation characteristics, providing a basis for the process and equipment improvements aimed at quality enhancement.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Humanos , Controle de Qualidade , Comércio
5.
Sensors (Basel) ; 24(7)2024 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-38610443

RESUMO

The present work proposes a comprehensive metaheuristic methodology for the development of a medical robot for the upper limb rehabilitation, which includes the topological optimization of the device, kinematic models (5 DOF), human-robot interface, control and experimental tests. This methodology applies two cutting-edge triads: (1) the three points of view in engineering design (client, designer and community) and (2) the triad formed by three pillars of Industry 4.0 (autonomous machines and systems, additive manufacturing and simulation of virtual environments). By applying the proposed procedure, a robotic mechanism was obtained with a reduction of more than 40% of its initial weight and a human-robot interface with three modes of operation and a biomechanically viable kinematic model for humans. The digital twin instance and its evaluation through therapeutic routines with and without disturbances was assessed; the average RMSEs obtained were 0.08 rad and 0.11 rad, respectively. The proposed methodology is applicable to any medical robot, providing a versatile and effective solution for optimizing the design and development of healthcare devices. It adopts an innovative and scalable approach to enhance their processes.


Assuntos
Exoesqueleto Energizado , Robótica , Humanos , Comércio , Simulação por Computador , Engenharia
6.
Sensors (Basel) ; 24(7)2024 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-38610442

RESUMO

With the intent to further increase production efficiency while making human the centre of the processes, human-centric manufacturing focuses on concepts such as digital twins and human-machine collaboration. This paper presents enabling technologies and methods to facilitate the creation of human-centric applications powered by digital twins, also from the perspective of Industry 5.0. It analyses and reviews the state of relevant information resources about digital twins for human-machine applications with an emphasis on the human perspective, but also on their collaborated relationship and the possibilities of their applications. Finally, it presents the results of the review and expected future works of research in this area.


Assuntos
Comércio , Indústrias , Humanos , Intenção , Tecnologia
7.
J Environ Manage ; 357: 120806, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38583377

RESUMO

Corporate energy transition is crucial for long-term sustainable development. The widely discussed Artificial Intelligence (AI), as a disruptive technological innovation, is highly potential for enhancing environment performance. However, the specific impact of AI on the process of corporate energy transition and its underlying mechanisms have not been fully explored. This study focuses on A-share listed corporates in Shanghai and Shenzhen stock markets in China spanning from 2011 to 2021. Based on corporate annual report information and information from over 200,000 patent application texts, we innovatively construct indicators for corporate energy transition and AI technology application. Furthermore, we empirically investigate the impact of AI technology on corporate energy transition and its potential mechanisms through combining information asymmetry theory and institutional theory. The empirical results indicate that: 1) AI can drive corporate energy transition and the promoting effect of AI collaborative innovation on corporate energy transition should not be ignored. 2) AI can help corporates achieve energy transition through pathways such as mitigating information asymmetry, reducing financing constraints, adjusting sustainable development concepts and practices. 3) The driving effect of AI on corporate energy transition varies depending on the characteristics of different types of corporates, industries, and regions. This study provides strategic guidance and decision support for business managers and policymakers, assisting both corporates and governments in better utilizing AI technology during the social energy transition process to achieve a dual optimization of environmental and economic goals.


Assuntos
Inteligência Artificial , Organizações , China , Governo , Comércio
8.
PLoS One ; 19(4): e0299454, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38625894

RESUMO

This paper develops an outsourcing collaboration model from a firm's perspective operating in a developing economy. The model considers that producers of the final goods residing in a developed country, and operators of manufacturing plants in a developing country collaborate with each other. The final goods producer supplies headquarter services for the production of intermediate goods in the developing country. The operators of manufacturing plants also supply their services in the domestic economy. This arrangement leads to foreign outsourcing collaborations (FOC) between firms of developed country and developing country. The operators of manufacturing plant maximize revenue subject to the cost constraint. The first order conditions suggests that an increase in wages of skilled labor, price of domestic inputs, and cost of production deter FOC. On the other hand, an increase in demand for and price of foreign headquarter services increases the FOC. Empirical analysis based on data collected from 217 clothing (textile and apparel) firms in the city of Faisalabad (Pakistan) reveals that an increase in wage to labor-productivity ratio reduces FOC. An improvement in skilled of the labor and foreign headquarter services give rise to FOC, whereas an increase in economies-of-scope enhances FOC. Additionally, an inverted U-shaped relationship is found between the cost of production and FOC, which shows that at the initial stage, the firm's cost of production increases with an increase in the level of FOC, but soon after the tipping point, the firm's cost starts decreasing with a further increase in FOC.


Assuntos
Serviços Terceirizados , Indústria Têxtil , Humanos , Paquistão , Comércio , Salários e Benefícios
9.
PLoS One ; 19(4): e0299944, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38578747

RESUMO

The rapid development of science and technology has led to an increasing number of high-tech enterprises offering new products through successive generations of product upgrades. This trend presents a new challenge for the sustainable operations of enterprises. Based on the Norton-Bass model, this study begins by constructing a multi-generation product diffusion model within a single enterprise in the context of a monopoly under the quality upgrade scenario. Subsequently, a supply model is established based on this foundation, and these two models are seamlessly integrated using product sales volume as an interface, culminating in a comprehensive sales-supply system. This study analyzes the effects of new-product pricing, quality levels, initial stock, and production capacity on the performance of this system. The system dynamics (SD) method was used to simulate and solve the system in the decentralized and centralized decision-making modes, and the two decision-making modes were compared and analyzed. The research reveals several key findings. i) Comprehensive decision optimization yields enhanced profitability through joint optimization calculation of the multi-generation product diffusion system and the supply adjustment system. ii) consumer price sensitivity significantly affects product quality upgrades and profits. A negative correlation exists between consumer price sensitivity and both factors. The upgrades of product quality should be carefully traded off with consideration of pricing and quality costs. iii) Maximizing profits by maintaining a certain order level of backlog or stock shortage is beneficial for overall enterprise profitability. Additionally, optimal production capacity has been identified as a crucial element in efficient operational inventory management. This study expands the multi-generation product diffusion operational theory and provides valuable theoretical support and decision-making foundations for the sustainable management of enterprises.


Assuntos
Comércio , Tecnologia , Custos e Análise de Custo
10.
PLoS One ; 19(4): e0301229, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38578778

RESUMO

The popularity of martial arts in the present times has become apparent, therefore, it is necessary to explore martial artists' preferences and the schools' competitiveness. The purpose of this study was to assess martial artists' preferences concerning the services offered by martial arts schools. Conjoint analysis was utilized to analyze the responses of fifty-five (55) martial artists based on the seven (7) martial arts schools' attributes. The results showed that the type of martial arts was found to be the most important attribute (30.449%) followed by distance (27.970%), price range (22.706%), social environment (11.097%), class preference (5.080%), goal (1.562%), and schedule (1.135%). Furthermore, Muay Thai or Kickboxing was the most preferred martial art, Mixed Martial Arts (MMA) was the second priority, next was Taekwondo, then Karate, and finally Boxing. In addition, the martial artists' preferred distance was less than 8 km, and a monthly training cost of 150,000 to 450,000 IDR (10 to 20 USD). Martial artists liked attending open classes, treated martial arts as a hobby, and favored attending classes once or twice weekly. With the lack of conjoint-related studies in the martial arts industry, the findings contributed to academicians and addressed issues of inadequate studies. Most importantly, the researchers presented managerial implications to leverage marketing techniques and develop the business operations of martial arts schools.


Assuntos
Boxe , Artes Marciais , Indonésia , Artes Marciais/fisiologia , Instituições Acadêmicas , Comércio
11.
PLoS One ; 19(4): e0301286, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38578793

RESUMO

Enhancing green innovation for business sustainability represents a pressing global challenge. In the context of the manufacturing industry, the relationship between proactive green innovation (PGI) and structural social capital (SSC) remains a profoundly under-researched area. Drawing upon the theories of social capital and dynamic capability (DC), this study investigated the relationship between SSC and PGI within manufacturing enterprises via three individual and sequential mediating factors, namely cognitive social capital (CSC), relational social capital (RSC), and DC. Adopting a cross-sectional quantitative design, this study collected survey data from 485 manufacturing sector employees in China using purposive sampling. Structural equation modeling analysis of the data revealed no significant direct impact of SSC on PGI, but a strong indirect impact through the sequential mediating influences of CSC, RSC, and DC. The findings suggests that PGI within manufacturing enterprises is not wholly shaped by SSC; rather, firm-level dynamic capabilities, characterized by a sequential mechanism, plays a crucial role in achieving PGI within these enterprises. This paper offers both theoretical and practical contributions and provides recommendations for future research based on its limitations.


Assuntos
Capital Social , Humanos , Estudos Transversais , China , Comércio , Análise de Classes Latentes
12.
PLoS One ; 19(4): e0297787, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38578812

RESUMO

Protecting human, animal, and plant life or health from additives, toxins, and contaminants in agri-products and promoting green free trade are the main components of Sanitary and Phytosanitary (SPS) measures. However, the SPS measures are heterogeneous. This study examines the impact of SPS measures on the measured export quality and discusses their influence on the environmental protection of the exporting country. International heterogeneous measures do not necessarily promote quality upgrading but greatly increase transaction costs. By contrast, China's agri-product' quality upgrading and environmental pollution are in sharp contrast. Based on a heterogeneous firm-trade model, this study obtains three hypothetical propositions and conducts empirical regressions using the Tobit method. This study finds that heterogeneous SPS measures hinder quality upgrading because firms present a different quality upgrading trend, which in turn impedes the environmental protection of the exporting country; the quality upgrading made by diversified SOEs is higher than that of foreign firms and private firms; the quality upgrading made by general firms is higher than that of processing firms; and protective SPS measures have a stronger negative effect on quality upgrading and environmental protection.


Assuntos
Conservação dos Recursos Naturais , Cooperação Internacional , Animais , Humanos , Comércio , Internacionalidade , Poluição Ambiental/prevenção & controle , China
13.
Nat Commun ; 15(1): 2955, 2024 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-38580696

RESUMO

Physical unclonable functions (PUFs) based on unique tokens generated by random manufacturing processes have been proposed as an alternative to mathematical one-way algorithms. However, these tokens are not distributable, which is a disadvantage for decentralized applications. Finding unclonable, yet distributable functions would help bridge this gap and expand the applications of object-bound cryptography. Here we show that large random DNA pools with a segmented structure of alternating constant and randomly generated portions are able to calculate distinct outputs from millions of inputs in a specific and reproducible manner, in analogy to physical unclonable functions. Our experimental data with pools comprising up to >1010 unique sequences and encompassing >750 comparisons of resulting outputs demonstrate that the proposed chemical unclonable function (CUF) system is robust, distributable, and scalable. Based on this proof of concept, CUF-based anti-counterfeiting systems, non-fungible objects and decentralized multi-user authentication are conceivable.


Assuntos
Algoritmos , Comércio , DNA , Relação Estrutura-Atividade
14.
Int J Mol Sci ; 25(7)2024 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-38612662

RESUMO

In this study, a new micro delivery system based on an anionic methacrylate copolymer, able to improve the biological response of myo-inositol by daily oral administration, was manufactured by spray-drying. It has an ideal dose form for oral administration, with an experimental drug loading (DL)% of 14% and a regulated particle size of less than 15 µm. The new formulation features an improvement on traditional formulations used as a chronic therapy for the treatment of polycystic ovary syndrome. The microparticles' release profile was studied and ex vivo porcine intestinal mucosa permeation experiments were performed to predict potential improvements in oral absorption. Batch n. 3, with the higher Eudragit/MI weight ratio (ratio = 6), showed the best-modified release profiles of the active ingredient, ensuring the lowest myo-inositol loss in an acidic environment. The in vivo evaluation of the myo-inositol micro delivery system was carried out in a rat animal model to demonstrate that the bioavailability of myo-inositol was increased when compared to the administration of the same dosage of the pure active ingredient. The AUC and Cmax of the loaded active molecule in the micro delivery system was improved by a minimum of 1.5 times when compared with the pure substance, administered with same dosage and route. Finally, the increase of myo-inositol levels in the ovary follicles was assessed to confirm that a daily administration of the new formulation improves myo-inositol concentration at the site of action, resulting in an improvement of about 1.25 times for the single administration and 1.66 times after 7 days of repeated administration when compared to pure MI.


Assuntos
Micropartículas Derivadas de Células , Metacrilatos , Feminino , Animais , Ratos , Suínos , Disponibilidade Biológica , Administração Oral , Comércio , Polímeros
15.
Nutrients ; 16(7)2024 Mar 23.
Artigo em Inglês | MEDLINE | ID: mdl-38612967

RESUMO

Herbal medicines are used by patients with IBD despite limited evidence. We present a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating treatment with herbal medicines in active ulcerative colitis (UC). A search query designed by a library informationist was used to identify potential articles for inclusion. Articles were screened and data were extracted by at least two investigators. Outcomes of interest included clinical response, clinical remission, endoscopic response, endoscopic remission, and safety. We identified 28 RCTs for 18 herbs. In pooled analyses, when compared with placebo, clinical response rates were significantly higher for Indigo naturalis (IN) (RR 3.70, 95% CI 1.97-6.95), but not for Curcuma longa (CL) (RR 1.60, 95% CI 0.99-2.58) or Andrographis paniculata (AP) (RR 0.95, 95% CI 0.71-1.26). There was a significantly higher rate of clinical remission for CL (RR 2.58, 95% CI 1.18-5.63), but not for AP (RR 1.31, 95% CI 0.86-2.01). Higher rates of endoscopic response (RR 1.56, 95% CI 1.08-2.26) and remission (RR 19.37, 95% CI 2.71-138.42) were significant for CL. CL has evidence supporting its use as an adjuvant therapy in active UC. Research with larger scale and well-designed RCTs, manufacturing regulations, and education are needed.


Assuntos
Colite Ulcerativa , Plantas Medicinais , Humanos , Colite Ulcerativa/tratamento farmacológico , Extratos Vegetais , Terapia Combinada , Comércio
16.
Nutrients ; 16(7)2024 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-38613091

RESUMO

Reporting key dietary indicators from sales data can help us guide store decision makers in developing effective store policy to support healthier customer purchases. We aimed to develop a web-based reporting tool of key dietary indicators from sales data to support health-promoting policy and practice in stores in geographically remote Aboriginal and Torres Strait Islander communities. Tool development included identifying key dietary indicators (informed by sales data from 31 stores), community consultation (19 Aboriginal and Torres Strait Islander store directors and two store managers) and a web-build. Tool evaluation involved feedback interviews with stakeholders (25 store managers and two nutritionists). Key dietary indicators aligned with Australian Dietary Guideline food groupings and recommendations. An online portal for accessing and customising reports was built. Stakeholder feedback indicated that the strengths of the reports were the visuals, ease of interpretation, providing information that was not currently available and potential to increase capacity to support healthy food retailing. Difficulties were defining healthiness classification with alignment to other nutrition guidelines used and ensuring reports reached relevant store decision makers. This tool may be valuable to support store decision makers in identifying and prioritising nutrition issues and optimising the health-enabling attributes of stores.


Assuntos
Povos Aborígenes Australianos e Ilhéus do Estreito de Torres , Dieta , Humanos , Austrália , Comércio , Política de Saúde
17.
BMC Health Serv Res ; 24(1): 464, 2024 Apr 13.
Artigo em Inglês | MEDLINE | ID: mdl-38614980

RESUMO

BACKGROUND: The COVID-19 pandemic has impacted peoples' health-related behaviors, especially those of older adults, who have restricted their activities in order to avoid contact with others. Moreover, the pandemic has caused concerns in long-term care insurance (LTCI) providers regarding management and financial issues. This study aimed to examine the changes in revenues among LTCI service providers in Japan during the pandemic and analyze its impact on different types of services. METHODS: In this study, we used anonymized data from "Kaipoke," a management support platform for older adult care operators provided by SMS Co., Ltd. Kaipoke provides management support services to more than 27,400 care service offices nationwide and has been introduced in many home-care support offices. The data used in this study were extracted from care plans created by care managers on the Kaipoke platform. To examine the impact of the pandemic, an interrupted time-series analysis was conducted in which the date of the beginning of the pandemic was set as the prior independent variable. RESULTS: The participating providers were care management providers (n = 5,767), home-visit care providers (n = 3,506), home-visit nursing providers (n = 971), and adult day care providers (n = 4,650). The results revealed that LTCI revenues decreased significantly for care management providers, home-visit nursing providers, and adult day care providers after the COVID-19 pandemic began. The largest decrease was an average base of USD - 1668.8 in adult day care. CONCLUSION: The decrease in revenue among adult day care providers was particularly concerning in terms of the sustainability of their business. This decrease in revenue may have made it difficult to retain personnel, and staff may have needed to be laid off as a result. Although this study has limitations, it may provide useful suggestions for countermeasures in such scenarios, in addition to support conducted measures.


Assuntos
COVID-19 , Gerentes de Casos , Humanos , Idoso , COVID-19/epidemiologia , Seguro de Assistência de Longo Prazo , Pandemias , Comércio
18.
BMJ Open ; 14(4): e080405, 2024 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-38604637

RESUMO

BACKGROUND AND OBJECTIVES: On 6 April 2022, the UK government implemented mandatory kilocalorie (kcal) labelling regulations for food and drink products sold in the out-of-home food sector (OHFS) in England. Previous assessments of kcal labelling practices in the UK OHFS found a low prevalence of voluntary implementation and poor compliance with labelling recommendations. This study aimed to examine changes in labelling practices preimplementation versus post implementation of mandatory labelling regulations in 2022. METHODS: In August-December 2021 (preimplementation) and August-November 2022 (post implementation), large OHFS businesses (250 or more employees) subject to labelling regulations were visited. At two time points, a researcher visited the same 117 food outlets (belonging to 90 unique businesses) across four local authorities in England. Outlets were rated for compliance with government regulations for whether kcal labelling was provided at any or all point of choice, provided for all eligible food and drink items, provided per portion for sharing items, if labelling was clear and legible and if kcal reference information was displayed. RESULTS: There was a significant increase (21% preimplementation vs 80% post implementation, OR=40.98 (95% CI 8.08 to 207.74), p<0.001) in the proportion of outlets providing any kcal labelling at point-of-choice post implementation. Only 15% of outlets met all labelling compliance criteria post implementation, with a minority of outlets not presenting labelling in a clear (33%) or legible (29%) way. CONCLUSION: The number of large businesses in the OHFS providing kcal labelling increased following the implementation of mandatory labelling regulations. However, around one-fifth of eligible outlets sampled were not providing kcal labelling 4-8 months after the regulations came into force, and the majority of businesses only partially complied with government guidance. More effective enforcement may be required to further improve kcal labelling practices in the OHFS in England. PREREGISTRATION: Study protocol and analysis strategy preregistered on Open Science Framework (https://osf.io/pfnm6/).


Assuntos
Alimentos , Restaurantes , Humanos , Ingestão de Energia , Inglaterra , Comércio
19.
PDA J Pharm Sci Technol ; 78(2): 169-175, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38609148

RESUMO

The continuous processing session at the 2023 Viral Clearance Symposium (VCS) focused on understanding how to effectively design viral clearance operations for use in continuous processes and methods to perform viral clearance studies. In this session, an approach to directly address control considerations with operating continuous-flow reactors for low pH viral inactivation was presented. Continuous-flow low pH incubation chamber design and implications for residence time determination were discussed. Additionally, viral clearance capability between batch operation and connected operation were demonstrated to be comparable for a connected bind-elute chromatography and flow-through chromatography step. Overall, this session provided additional scientific knowledge to support viral clearance strategies when implementing a continuous manufacturing process.


Assuntos
Comércio , Conhecimento , Cinética , Fatores de Tempo , Inativação de Vírus
20.
PDA J Pharm Sci Technol ; 78(2): 147-156, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38609153

RESUMO

This session deals with the rational design of viral clearance studies for biopharmaceuticals including recombinant proteins such as monoclonal antibodies and, as new in scope of the symposium, also viral clearance for adeno-associated viral (AAV) vectors. For recombinant proteins, large datasets were accumulated over the last decades and are intended to be used for accelerated product process development and streamlining of viral clearance studies. How to utilize prior knowledge in viral clearance validation and how it can be used in a risk assessment tool to decide whether additional virus clearance studies are necessary during product development is being addressed by three of the presentations of this session. This also includes an a priori intended design and generation of validation data for a new kind of detergent such as CG-110, to build up a platform dataset to be used as prior knowledge in future marketing application. Another presentation investigates the virus removal mechanism of a newly developed hydrophobic interaction chromatography (HIC) resin and demonstrates for highly hydrophobic antibodies appropriate reduction for a retrovirus and impurities in a defined process range in contrast to the moderate to poor virus reduction of recent HIC resins. The last two presentations deal with virus clearance approaches for AAV, which will become mandatory with approval of the ICH Q5A revision. Appropriate virus removal and virus inactivation procedures can be implemented into the manufacturing processes of AAV vectors including viral filtration, viral inactivation (e.g., heat inactivation), affinity chromatography, and anion-exchange chromatography with which it seems possible to achieve a good clearance for helper and also adventitious viruses. The heat treatment step can be even a robust step for adenovirus helper inactivation for AAV products when product characteristics and process conditions are understood.


Assuntos
Anticorpos Monoclonais , Produtos Biológicos , Cromatografia de Afinidade , Comércio , Proteínas Recombinantes
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