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According to market research, the API market is expected to experience a compound annual growth rate of 6.7% in the forecast period of 2020-2027 (1). "The low-cost benefits of manufacturing APIs and drug products within Asia has helped to turbocharge the generic drug industry and expand global access to a range of lower-cost medication options," says Meudt. "The shift has been positive for patients, allowing consumers to benefit from lower cost drugs from US Food and Drug Administration (FDA) and European Union (EU) inspected current good manufacturing practice (cGMP) facilities while still maintaining quality, innovation, and allowing efficient drug development and commercialization routes," he says. "While manufacturing cost will always be important, pharmaceutical companies are increasingly selecting their long-term CMOs based upon other factors including security of quality and supply, regulatory track record, data control, and environmental sustainability.
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In December 2020, two shipments of the vaccine experienced temperature excursions in which product was actually kept at overly cold temperatures (3). Urgent need to protect data One problem that vaccine developers and regulatory agencies need to address is the urgent need to protect data, says Nigel Thorpe, technology director with Secure Age, which specializes in enterprise data encryption using a public key infrastructure platform. For operators on the plant floor, the efforts required are fraught with potential error, especially during shift changes, says Jim Evans, director of Verista, Inc.'s vision, connectivity, and automation division. Raw materials The speed with which vaccines have been developed and are being distributed pose important questions centred around variability. If we're having a raw materials shortage when the vaccines haven't even been scaled up, what will happen when they get full approval?" he asks.
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The company's Lyoguard trays are being used in the production of mAbs;diagnostics tests for COVID-19 virus or antibodies;and some of the key raw materials used in messenger RNA (mRNA) vaccines, including synthetic oligonucleotides, adjuvants, and lipid nanoparticles, he says. [...]it's a question of capacity. Another problem is the fact that lyophilization involves very slow cooling, at a rate of one degree Kelvin per second, says Bill Williams, a professor at the University of Texas and inventor of the thin-film freezing process, which he developed years ago at the Dow Chemical Co. TFF Pharma licensed his technology and commercialized it in 2019. Williams and his team, with corporate and US government funding, are now focusing on research designed to optimize use of thin-film freezing to improve the processing and delivery of biologics, including vaccines, along with the cold chain.
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"Though Europe's response has demonstrated strengths," the strategy document reports, "existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines, or the availability of manufacturing capacities to adapt and support the production of medicines" (2). [...]a lot of the strategy's proposals stem from the European Green Deal, published in late 2019 (4), from which has emanated last year's EU industrial strategy (5). [...]setting up critical medicines production capacity in the EU would have to be compliant with the Union's competition rules and those of the World Trade Organization, the commission warned (2).
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[...]of the disruptions caused by the COVID-19 pandemic, global arbitration has adapted to a 'new normal'. Arbitration trends A number of trends are emerging with respect to life sciences disputes that are anticipated to continue for the foreseeable future, including in particular: * A greater number of disputes arising out of global supply chain disruptions, and use of the pandemic as a defence to contractual non-performance * An increase in disputes over earn-out clauses and pre-closing covenants in M&A transactions * A rise in investor-state claims brought by investors against states for breach of international investment protection agreements * More insolvent parties in arbitrations, which pose particular challenges * An increase in third-party funding of significant claims in international arbitration * The continued use of efficient procedures by arbitral tribunals, including paperless proceedings and remote hearings. Earn-out arrangements are usually intended to bridge the gap between diverging valuations of the target company by the buyer and the seller at the time of closing-in addition to the upfront purchase price, the seller of a business receives further payouts if and when the target company achieves certain agreed performance targets over an agreed period of time after closing. [...]the seller trades the certainty of a lower upfront payment for a potential higher pay-out in the future. [...]party funding of claims Third-party funding of significant claims is now a common feature in international arbitration and has become available in jurisdictions that previously were subject to regulatory restrictions.
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The COVID-19 pandemic has significantly impacted the forest-products industry locally and globally, including the availability of raw materials, supply chain, production, and product sales. Therefore, it was essential to study the effect of COVID-19 in Central and Southeast European countries, including Slovenia, Croatia, Serbia, and Bosnia and Herzegovina, where the forest-products industry plays a vital global role. An international group of wood scientists developed and implemented the web-based questionnaire that consisted of four parts: demographic questions, production changes, COVID data gathering, governmental response to COVID-19, and lessons learned. Participants were mainly from furniture production, joinery, and wood processing. Results indicate that more than 80% of respondents reported negative changes. The COVID-19 pandemic has seriously affected the supply chain, and the most significant changes were in the availability of solid wood (23%) and engineered wood products (21%). Among the most critical issues were increased prices of all materials, increased transportation costs, extended delivery times, limited quantities for all materials, and total disruption of supply chains.
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Reevaluating the supply chain and timelines The pandemic highlighted a variety of issues related to the biopharmaceutical supply chain, and supply chain risk mitigation, especially for APIs, has become increasingly important, says Gene Nakagawa, EVP business development at LGM Pharma. Joe Sinclair, vice president, corporate strategy and business development at Vibalogics, agrees the pandemic caused a global trade disruption, and supply chain management is crucial. "Video conferencing and remote communications dominate the way we perform internal and external communications. Since there is no way to visit facilities for an audit, at least in India for the time being, CMOs who have good track record will continue to get recommendations from fellow clients," says Davuluri. "COVID-19 has made everyone in the industry revisit their sourcing strategies and risk management;even companies with stable in-house facilities have reassessed their risk profiles and vulnerabilities in supply chain, and sought after CDMO partnerships," says James Choi, chief information and marketing officer at Samsung Biologies.
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The added pressure of meeting accelerated deadlines during a pandemic presents additional challenges for process development, materials supply, equipment acquisition and installation, and process validation. Experience of model design and in the identification of potential critical process parameters (CPPs) are crucial to the successful scale up of new chemical entities (NCEs). Supply chains must secure sufficient supply of additional raw materials to meet expanded production. [...]it is important to accept only projects that fit the capabilities of the organization to avoid failure, especially in times of drug shortages.
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In the short term, Sebastian Tomlin, logistics manager at Charles River, a contract research and development firm, says that time and investment in supply chain management and logistics operations are needed to expedite the movement of materials during this crisis. "By far, a cradle-to-grave supply chain with local starting materials, ingredients, and excipients for essential drug production will help to support resilient supply chains by removing the reliance on imports and driving new investments in green chemistry and Pharma 4.0 efforts." Maintaining a high safety stock of critical APIs and other materials is imperative, says Vincent Colicchio, vice-president and Head-Supply Chain and External Manufacturing for North America Generics at Dr. Reddy's Laboratories. Having a stringent process for qualifying material suppliers is also important, according to Hamilton Lenox, senior vice-president, business development at LGM Pharma, an API sourcing and supply chain management company.
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The COVID-19 pandemic has resulted in changes in consumer behavior and has created new opportunities and challenges for the provisioning of green products in emerging economies. The objective of this study was to identify how perceptions on COVID-19 affected the variables of planned behavior and responsible purchase intention during the pandemic in Colombia. A total of 320 consumers participated in an online survey, and the responses were analyzed using a structural equation model (SEM) and AMOS 24 statistical software. The results were positive regarding the development of better environmental awareness, indicating that COVID-19 (COV) influenced the attitude (ATT) of individuals and contributed to subjective norms (SNs) and perceived behavioral control (PBC), and that SNs and ATT influence eco-friendly purchase intention (EFPI). However, PBC does not contribute to EFPI. Colombian consumers have become aware of the importance to society of buying eco-friendly products, and planned behavior is an opportunity for organizations to formulate new portfolios relevant to the needs of the market. This is an important opportunity to sensitize consumers to the purchase of environmentally friendly products and for the identification of commercial strategies by companies that bet on the formulation and commercialization of eco-friendly portfolios that generate value for society.
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This paper presents raw plant materials and their characteristic compounds which may affect the immune system. Plant-derived agents in specific doses affect the body's non-specific, antigen-independent defense system. They have immunostimulatory effects on the entire immune regulatory system. They can enhance the immune response through various factors such as macrophages, leukocytes, and granulocytes, as well as through mediators released by the cellular immune system. This paper was inspired by the threats caused by the COVID-19 pandemic. The proper functioning of the immune system is important in limiting the effects of viral infection and restoring the normal functioning of the body. This paper also emphasizes the importance of the skillful use of plant immunostimulants by potential patients, but also by those who prescribe drugs. It is important not only to choose the right plant drug but above all to choose the correct dose and duration of treatment.
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With additional safety protocols required in the manufacturing environment, gatherings of large people generally prohibited, and onsite inspections limited due to restricted travel, ensuring quality throughout the supply chain from raw material to API is more challenging. Employee safety is always a priority for Thermo Fisher Scientific, and since the start of the COVID-19 pandemic the company has focused on protecting their health and safety while continuing to serve the needs of its customers, according to Vice President of Drug Substance Quality, Ben Gerlach. [...]of the support, flexibility, and discipline of our colleagues and supply chain partners, as well as the IT infrastructure available, all Thermo Fisher API manufacturing sites have remained operational since the start of the pandemic with continued GMP compliance," Gerlach remarks. Expanding our footprint and ensuring supply chain redundancy has enabled us to minimize the risk of supply chain interruptions and work with partners efficiently," he explains. Because of the circumstances connected with COVID-19, Ross also stresses that it is extremely important to frequently engage with supply chain partners to ensure that Cambrex understands the impact of the pandemic on their businesses and any potential downstream effects on Cambrex's unit operations that might ensue.
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COVID‐19, which is a global problem, affects the all supply chains throughout the world. One of the supply chains most affected by COVID‐19 is food supply chains. Since the sustainable food supply chain processes are complex and vulnerable in terms of product variety, it has been negatively affected by the operational effects of COVID‐19. While the problems experienced in the supply chain processes and raw material constraints caused stops in production, the importance of new business models and production approaches came to the fore. One of the issues of increasing importance is the adoption of reverse logistics activities in sustainable food supply chains and increasing the resilience of food supply chains by integrating blockchain technology into processes. However, adapting blockchain technology to increase the resilience of reverse logistics activities in the food supply chain has advantages as well as risks that need to be considered. Therefore, it is aimed to determine these risks by using fuzzy synthetic evaluation method for eliminating the risks of blockchain adaptation for flexible reverse logistics in food supply chains to increase resiliency. The novelty of this study is that besides discussing about the benefits of BC‐T, it is to identify the risks it can create, to eliminate these risks and to guide the establishment of resilience in reverse logistics activities of SFSCs. According to results, the risks with the highest value among the subrisks are determined as data security risks. Data management risks are calculated as the risk with the highest value.
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This study aims to determine the effect of environmental strategy on dynamic capabilities based on digital literacy and the performance of marketing innovations for micro, small and medium enterprises. Digital literacy-based dynamic capabilities consist of two important components, namely marketing competencies and research and development competencies. The nature of this research is explanatory where the number of research samples is micro, small and medium enterprises that have used information technology with a total number of respondents as many as 200 micro, small and medium enterprises which are divided proportionally to seven regions in Indonesia with the sampling method using accidental sampling method. The data analysis technique used SEM analysis with the help of AMOS software. The results showed that environmental strategy had no significant effect on marketing competence. Environmental strategy has a significant effect on the direction of a positive relationship to research and development competencies and has a significant effect on the direction of a positive relationship on the marketing innovation performance of micro, small and medium enterprises. Marketing competence and research and development competence have a significant effect with a positive direction of relationship to the marketing innovation performance of micro, small and medium enterprises. Research and development competence has a significant effect on the direction of a positive relationship to the marketing performance of micro, small and medium enterprises.
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The purpose of this research is to study the changes in the market structure of China's pulp and paper product imports. In particular, the import trade environment and market layout of Chinese pulp and paper products have changed under the international context of the coronavirus pandemic and the Sino-US trade dispute and the domestic policy context of zero imports of Chinese waste paper. This study attempts to fill the gap regarding the influencing factors of market structure, while contributing new ideas on China's trade in pulp and paper products. Based on pulp and paper product import and export trade data from 2005 to 2021, a trade gravity model was used to explore the changes in the share of China's trade partners for pulp and paper product imports and their influencing factors. The results indicated that the outbreak of COVID-19 led to a significant increase in China's imports of packaging paper products, bringing about an increase in Indonesia's status as a partner in China's pulp and paper product trade. The US-China trade dispute had an impact on pulp and paper product trade between the two countries, with China's tax countermeasures causing the US to lose its status as a trading partner in China for pulp and paper product imports. The center of gravity for paper product imports has moved from the US and Japan to Indonesia and Russia. The restrictions on waste paper imports have shifted the focus of China's paper raw material imports, with the US no longer being the main importer of China's paper raw materials. Specifically, the main importers of wood pulp are Brazil and Chile, while the main importers of waste paper pulp are Thailand and Malaysia. In the future, China needs to continuously strengthen dialogue with the United States to resolve trade disputes and create a favorable environment for trade in pulp and paper products. At the same time, China's paper enterprises should strengthen the expansion of the Southeast Asian market and reduce dependence on the US market, and China should continue to improve the waste paper recycling system and improve the utilization rate of domestic waste paper.
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Biodrying is an essential part of the mechanical–biological treatment process that minimizes moisture content and simultaneously maximizes heating value for refuse-derived fuel (RDF) production. Although the mechanical separation process operates effectively in Thailand's RDF production, high organic content levels and their degradation cause moisture contamination in RDF, producing wet RDF. Aeration is essential for an effective biodrying process, and can reduce RDF's moisture content as well as increase its heating value. To maximize the biodrying effect, aeration should be optimized based on the waste conditions. This study proposes a modified aeration-supplied configuration for wet RDF biodrying. The aeration rate was modified based on the period within the biodrying operation;the first period is from the beginning until day 2.5, and the second period is from day 2.5 to day 5. The optimal aeration supply configuration was 0.5 m3/kg/day in the first period and then 0.3 m3/kg/day until the end of the process;this configuration yielded the greatest moisture content decrease of 35% and increased the low heating value of the biodried product by 11%. The final moisture content and low heating value were 24.07% and 4787 kcal/kg, respectively. Therefore, this optimal aeration-supplied configuration could be applied to meet the moisture content and low heating value requirements of the RDF production standard for Thailand's local cement industry.
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The last century has witnessed European commercial aviation flourishing at the cost of environmental degradation by boosting greenhouse gas and CO2 emissions in the atmosphere. However, the outcry for net-zero emissions compels the sector's supply chain to a minimum 55% reduction of greenhouse gas emissions below the 1990 level by 2030 and zero CO2 emissions by 2050. This study examines a European environmental sustainability path toward a green commercial aviation supply chain. Driven by literature and a review of related documents, two propositions were advanced to orient perspectives on the relationship between pollution and the commercial aviation supply chain and actions being taken toward environmental sustainability. In semi-structured interviews, seventeen aerospace associates endorsed pollution sources in the commercial aviation supply chain during the four stages of the aircraft life cycle, including extracting the raw materials, manufacturing, ground and flight operations, and end-of-service. They recommended transitioning into green commercial aviation through the widespread deployment of innovative technologies, from modifying airframes to changing aviation fuel, utilizing alternative propulsion systems, adopting circular manufacturing, and improving air traffic management.
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The recovery of materials and energy from end-of-life products is increasingly a fundamental factor in the sustainable development of various countries. Recovering metals from different types of waste is not only a practice in support of the environment, but is also a profitable economic activity. For this reason, exhausted automotive catalysts can become renewable sources of critical raw materials such as Pt, Pd, and Rh. However, recovering Pt and Pd from spent catalysts through an efficient, economical, and green method remains a challenge. This article presents a new leaching process for the hydrometallurgical recovery of Pt and Pd from exhausted automotive catalysts. The leaching solution consists of an aqueous mixture of hydrochloric acid, two organic acids (citric acid and acetic acid) and hydrogen peroxide. A complete factorial plan on two levels (2k) was performed in order to evaluate the main effects of the analyzed factors and their interactions. The factors that were presumed to be the most influential on the leaching of Pt and Pd were the concentrations of the different reagents and the reaction time. The optimal circumstances for achieving the largest recovery (over 80% Pt and 100% Pd) were achieved using the following conditions: a concentration of HCl of 5 M, a concentration of H2O2 of 10% wt./vol., a concentration of C2H4O2 of 10%vol./vol., and a reaction time of 3 h.
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Stoneware is a ceramic material with low porosity and high mechanical properties, such as the modulus of rupture. It is essentially made of clay, feldspar and quartz and is sintered to create a mixture of glass and crystalline phases. With the projected growth rate of the global ceramics market size and the country's development plan for 2023–2028, it is imperative that alternative raw materials for the manufacture of ceramic products be sourced so that the importation of these materials, such as feldspar, be minimized, if not eliminated. Cinder in the Philippines is mainly used as a filling material in pavements and residential areas. In this study, this resource is utilized as partial and full replacement of feldspar in a typical ternary diagram for stoneware production. Bars were formed from different formulations by the slip casting method and were sintered at 1200 °C. Physical and mechanical properties of the bars, such as shrinkage, loss on ignition, water absorption, apparent porosity and modulus of rupture were determined. Thermo-physical analyses were also carried out on the raw materials and on formulated powders. Meeting the requirements of the various quality standards for ceramics, the partial replacement of feldspar with black cinder (LF, LFBQ and LFBH) is feasible for wall and roof applications while full replacement of feldspar with black cinder (LB) is suitable for wider use as wall, floor, vitrified, industrial and roof tiles.
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As the world was emerging from the Covid-19 pandemic earlier this year, it was thrown off course by the Russian invasion of Ukraine. Geopolitical instability and conflicts now remain a top concern as the greatest risk to global growth over the next 12 months. Production costs are rising. We are in a totally new world, and companies are going to have to reconfigure how they think about their operations. Against this backdrop, the global sugar industry, invariably sucked in the vortex of the storm will have to manage. Sugar prices are holding up, moderated as much by climate volatility dictating uncertainty and macroeconomic indicators, in particular the value of US$. Global sugar production in 2022/23 (Oct/Sep) is forecast at 191.1 million tonnes raw value (mtrv) while the consumption is expected to rise by 0.9% to 186.8 million tonnes suggesting a global surplus following the deficit of 2.2 mtrv in the previous year. Sugar production in the top-producing countries Brazil, India and Thailand will sway the market as will the top consumers Indonesia and China.