Biopharmaceutical Enterprises Research Articles

Recent landscape and trends for industry-sponsored pediatric clinical trials in China from 2013 to 2022.

Pediatric medication is a challenging issue globally. Promoting trials of medications for children and implementing measures to encourage innovation for addressing unmet medical and health needs are important. To explore the recent landscape of pediatric clinical trials of new investigational drugs conducted by pharmaceutical enterprises in China from 2013 to 2022 to provide insight into pediatric drug development in the pharmaceutical industry and regulatory policy formulation. We performed a cross-sectional observational investigation of pediatric clinical trials registered from January 1, 2013, to December 31, 2022, on the Registration and Information Disclosure Platform for Drug Clinical Trials, the official registration platform established in 2013 for trials of new investigational drugs initiated by biopharmaceutical enterprises. Trials that included pediatric participants (under 18 years old) were retrieved, and their relevant characteristics were extracted and analyzed. In total, 895 pediatric clinical trials were collected, accounting for 5.1% of the total registered clinical trials initiated prior to January 1, 2023. The overall average annual growth rate for the number of pediatric clinical trials was 12% (P < 0.001). Phase III trials accounted for the highest proportion (49.1%, 439). Of the 895 trials included, 736 (82.2%) were domestic trials, and 159 (17.8%) were international multicenter trials. In terms of tested drugs, investigations of biological products accounted for the largest proportion of trials (67.4%, 603). Among pediatric clinical trials, studies of vaccines accounted for the largest proportion of trials (41.0%, 367), followed by trials for rare diseases (17.2%, 154). Furthermore, geographical distribution analysis revealed that the largest and smallest numbers of trials were conducted in North China (35.7%, 320) and Northeast China (0.8%, 7), respectively. The growth trends for industry-sponsored clinical trials involving children illustrate the progress and increasing capability of pediatric drug development achieved in China since 2013. Current challenges and potential areas of focus for policymakers and stakeholders include investigating orphan drugs for rare diseases according to the unique epidemiological characteristics of Chinese children, expanding the scope of pediatric clinical trials, and improving the uneven geographical distribution of leading research centers.

Study on the Path to Improve the Sustainability Responsibility of Biomedical Enterprises Driven by Data

Abstract In today’s complex, changing, and competitive market environment, active and serious fulfillment of social responsibility is one of the important strategies for enterprises to gain competitive advantage. This paper combines relevant literature to construct the performance index system of sustainable development responsibility of biomedical enterprises, and then determines the weights of the evaluation index system based on game theory by jointly applying the Gl method and the CRITIC method, and constructs a fuzzy comprehensive evaluation model for the evaluation of sustainable development responsibility of biomedical enterprises. Based on this, relevant sample data of biomedical enterprises are crawled through data-driven technology to measure the fulfillment of sustainable development responsibility of the sample enterprises and further combined with structural equation modeling to explore the improvement path of sustainable development responsibility. The sample biopharmaceutical enterprises are affiliated with either poor or poor, except for the overall responsibility of the sample biopharmaceutical enterprises in 2017, 2019, and 2022, which are in the middle. Responsibility to employees (ER), responsibility to consumers (CR), responsibility to society and government (GR), responsibility to the environment (IR), and responsibility to suppliers (SR) all significantly and positively affect the sustainability responsibility of biopharmaceutical companies (all p &lt; 0.01). Biopharmaceutical enterprises should serve society with more scientific concepts, leaner management, and safer and more reliable pharmaceutical products to achieve sustainable development and gain wider social recognition.

Research on incentive and technological innovation models of biopharmaceutical companies

This article selects biopharmaceutical enterprises listed in high-tech industry as samples, using the Heckman selection model effectively avoid sample bias and according to linear analysis, this research tests the influence between senior management incentives and technological innovation based on the Chinese biopharmaceutical enterprises listed in high tech industry in a certain period. The empirical research results indicate that there is not a simple linear correlation between short-term salary incentives and technological innovation, and there is a curve relationship that first decreases and then increases among them; Long term equity incentives have a significant positive impact on technological innovation. This research aimed to find the maximum value of incentives, propose countermeasures and suggestions to avoid excessive salary incentives, appropriately improve the level of stock-based compensation, and establish a reasonable senior management incentive system for insight.

A study on the Development of Biopharmaceutical Companies Based on the Context of Big Data

Based on the requirements of the computer technology background in the new era, this paper takes Chinese biopharmaceutical enterprises as the research object, outlines the general characteristics of innovation in Chinese biopharmaceutical enterprises, and analyses the current situation of innovation development in biopharmaceutical enterprises from four aspects: policy, economy, society and technology, followed by an analysis of the current problems faced by innovation in Chinese biopharmaceutical enterprises and the reasons for their generation. Based on literature research, theoretical studies and analysis of the causes of the current innovation problems of Chinese biopharmaceutical enterprises, the factors affecting the innovation performance of Chinese biopharmaceutical enterprises are summarised. The specifics of the conditional variables, as well as the outcome variables, are then identified according to the specific manifestations of poor innovation performance of biopharmaceutical firms. Finally, corresponding countermeasures are proposed in terms of the level of corporate R&amp;D investment, the level of financing channels, the level of government policy support, and the internal management of biopharmaceutical companies, in conjunction with the characteristics of different path models. This paper combines the big data foundation to research and analyse the development of biopharmaceutical enterprises, laying a new research foundation and providing a more efficient research path for the development of the biopharmaceutical industry.

Pharmaceutical and Biopharmaceutical Industries: Revolutionizing Healthcare

The drug and biopharmaceutical enterprises play a pivotal part in transforming healthcare through the incident and delivery of creative cures and remedies. This item explores the key facets of these areas, stressing their impact on healthcare. Pharmaceuticals, outlined as wealthy secondhand in the diagnosis, situation, or stop of disease, aim to restore, correct, or refine everyday functions. On the other hand, biopharmaceuticals (or biologicals) circumscribe sugars, proteins, nucleic acids, living containers, or tissues and are curative devices that arise natural beginnings to a degree persons, animals, or microorganisms. In contrast to common pills combined with synthetic processes, biopharmaceuticals are primarily acquired through unaffected processes, containing extraction from living constructions or production utilizing alteration of genetic material Table 1. • Some usual biopharmaceuticals, originally gleaned from animals or persons, are immediately created through biotechnological advancements. • For instance, healing insulin, previously gleaned from porcine pancreatic islets, is immediately made utilizing alteration of genetic material in yeast (Saccharomyces cerevisiae) or E. coli. • Biopharmaceuticals caused by alteration of genetic material usually fall into three classifications: • Substances nearly equal to the body’s own key signaling proteins. • Monoclonal antibodies look like those caused by apiece human immune plan against bacteria. • Receptor builds (fusion proteins) established uniformly happening receptors connected to the immunoglobulin frame. Examples include From living systems: Whole blood and ancestry parts, organs and fabric transplants, stem containers, antibodies for inactive immunization, polluted microbiota, human bosom milk, and human reproductive containers. Produced by recombinant DNA: Blood determinants, fabric plasminogen activators, hormones, hematopoietic growth determinants, interferon, interleukin-located produce, vaccines, monoclonal antibodies, tumor loss determinants, therapeutic enzymes. • Key dispute Pharmaceutical manufacturing • Biopharmaceuticals • Healthcare strike • Innovative medicines • Therapeutic fragments • Recombinant DNA technologies • Personalized cure • Gene medicines • Regulatory processes

Bio‐pharma in Iran: Escaping the middle‐income trap

SummaryMotivationNeither state planning nor economic liberalization has allowed developing economies to escape from the middle‐income trap, owing mainly to institutional voids and hindering institutions. We need another explanation for development and the emergence of new institutions.PurposeHow have biopharmaceutical enterprises emerged in Iran, despite the obstacles faced? Can the collaborative agency of small groups of actors who know each other create new institutions and hence the conditions for biopharmaceutical firms to emerge? If so, who participates in such small groups, and how do they operate?Methods and approachWe interviewed 29 key participants and stakeholders in the Iranian bio‐pharma industry. We used grounded theory to identify key themes.FindingsBio‐pharma emerged owing to the efforts of a small group who successfully worked together to master the technology, to overcome institutional obstacles and widespread scepticism within Iran, and thereby to create new firms manufacturing biopharmaceuticals. The group succeeded because it was morally committed to creating the industry; it proceeded pragmatically, experimenting and learning; and leadership was shared and collective.Policy implicationsIn this case, we see the inverse of a top‐down process where government acts as principal and firms act as agents. Instead, strategic collaboration across government, university and firms, in a process of trial and error, has been able to make great progress to overcome obstacles to technical innovation that seem daunting for a middle‐income country.

VOC emitted by biopharmaceutical industries: Source profiles, health risks, and secondary pollution

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.

Current situation and future development of the biopharmaceutical industry in China: A mixed-method study

Introduction: The biomedical industry has grown significantly both globally and in China; however, there are still challenges. This study aimed at evaluating the biopharmaceutical sector of China, in terms of ability to innovate, current sales volume, investment, and R&D expenditure, as well as providing a case study detailing the progress and challenges of the industry in Shaanxi province. Method: A cross-sectional mixed-method study design was used to generate a comprehensive profile of the nature of biopharmaceutical innovation capacity and development in China by triangulating country-wide survey and interview data from Shaanxi province. Only biopharmaceutical companies that are currently marketing or conducting research and development were eligible for inclusion, and Shaanxi province was selected for conducting the interviews. Categorical and continuous variables were analyzed descriptively. Interviews were thematically analyzed by using NVivo version 12. Results: The analysis includes responses from 77 biopharmaceutical enterprises; the majority (36, 46.8%) are in Eastern China, followed by 26 (33.8%) in Central China. In 2018, the total sales of biological products amounted to 26.28 billion yuan, and in 2019, a slight increase was observed (30.34 billion); the amount doubled in 2020 to about 67.91 billion yuan. The top three biopharmaceutical products on sale in 2020 were Camrelizumab (5.14 billion yuan), human albumin (4.56 billion yuan), and human immunoglobulin for injection (3.78 billion yuan). Expenditure on R&D has also increased; it amounted to 1657.7 million yuan in 2018, which more than doubled in 2019 to 3572.1 million yuan and further increased to 5857.7 million yuan in 2020. Nonetheless, the progress is not uniform across all provinces, as shown from the results from Shaanxi province, because of lack of local government policies that will impact on the funding, incentives, and market share that motivate the producers. Conclusion: China’s biopharmaceutical industry has expand significantly. The increase in sales indicates that there is an increase in demand for biologicals; moreover, R&D funding is increasing. These are key indicators that influence innovation and development. However, the sector’s capacity to innovate and develop needs to be improved, particularly in the western region, where research and production are relatively weak.

Laboratory and Production Biosafety When Working With Bioobjects: Regulatory and Organizational and Technical Aspects

The use of pathogenic and opportunistic biological agents in research and production processes should be accompanied by risk management in the context of biosafety and biosecurity. These issues are regulated differently depending on the industry orientation, including organizational and technical support. To provide a safe environment for working with biological threats of various levels of risks is one of the urgent tasks of our time. Our article is an analytical review of modern approaches to biosafety management in laboratories and industries when working with hazardous biological objects, pollution, including issues of occupational safety management and organizational and technical support of biosecurity. We analyzed the current state of the problem on the implementation and provision of proper working conditions in biotechnological or related industries, as well as in laboratories and research centers operating with biolo­gical objects of various hazard classes. To achieve biosafety, the basic principle is to limit or prevent the spread of potentially hazardous or harmful biological agents. The article describes the classification of hazardous biological agents, the current requirements for ensuring biosafety for workers of biotechnological and biopharmaceutical enterprises, laboratories and research centers when working with biological material. Ensuring the appropriate level of biosafety in Ukraine is governed by a number of regulations concerning all areas and activities related to work with biological objects of various hazard levels. Adherence to strict regulatory requirements at all levels of the organization of work in laboratories, research institutions, and industries dealing with biological objects will ensure safe conditions for staff.

Probe into the Present Situation and Control Measures of Cost Management in Biopharmaceutical Enterprises

Probe into the Present Situation and Control Measures of Cost Management in Biopharmaceutical Enterprises

Research on Problems and Countermeasures of Cost Control in Biopharmaceutical Enterprises

Research on Problems and Countermeasures of Cost Control in Biopharmaceutical Enterprises

Considerations for applying bioethics norms to a biopharmaceutical industry setting

BackgroundThe biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main textAny institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context “specification” substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity.ConclusionUnderstanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society.

Opening the Box of Capability Creation: An Ethnographic Assessment

Capabilities are crucial to firms and their performance, but there is a lack of in-depth understanding of how they are created. I examine how new capabilities emerge in an ethnographic assessment of cooperations between a leading biopharmaceutical enterprise and its public partners over the course of three years. I develop a comprehensive model of capability creation comprising different generative mechanisms and supporting constructs. I label these mechanisms asymmetries, overflows, and redeployments, and show how each implies different origins of organizational capabilities and different paces of development over time. Efforts to lay out this model contribute to understanding the inner workings of capability creation and generate actionable insights on how to strengthen the development of capabilities.

Cyberbiosecurity in Advanced Manufacturing Models.

Cybersecurity for the production of safe and effective biopharmaceuticals requires the attention of multiple stakeholders, including industry, governments, and healthcare providers. Cyberbiosecurity breaches could directly impact patients, from compromised data privacy to disruptions in production that jeopardize global pandemic response. Maintaining cybersecurity in the modern economy, where advanced manufacturing technologies and digital strategies are becoming the norm, is a significant challenge. Here, we highlight vulnerabilities in present and future biomanufacturing paradigms given the dependence of this industry sector on proprietary intellectual property, cyber-physical systems, and government-regulated production environments, as well as movement toward advanced manufacturing models. Specifically, we (1) present an analysis of digital information flow in a typical biopharmaceutical manufacturing value chain; (2) consider the potential cyberbiosecurity risks that might emerge from advanced manufacturing models such as continuous and distributed systems; and (3) provide recommendations for risk mitigation. While advanced manufacturing models hold the potential for reducing costs and increasing access to more personalized therapies, the evolving landscape of the biopharmaceutical enterprise has led to growing concerns over potential cyber attacks. Gaining better foresight on potential risks is key for implementing proactive defensive principles, framing new developments, and establishing a permanent security culture that adapts to new challenges while maintaining the transparency required for regulated production of safe and effective medicines.

Curriculum design for training applied students of biopharmaceutical engineering based on the product life cycle

Biopharmaceutical engineering is a newly established undergraduate degree in China, and a lot of issues regarding students’ training remain to be explored and refined, particularly the curriculum reflecting the industrial needs for students with applied (hands-on) skills, which has been limited. To narrow the gap between industrial demands and students’ training and to provide undergraduates with rational curriculum, in the present investigation, we proposed to reconstruct the curriculum system for applied (hands-on) training of undergraduates of biopharmaceutical engineering based on the life cycle of medicinal products for the first time. A total of 52 subjects on the curriculum were selected and included in different stages of the medicinal products life cycle. After surveying from a recruitment website and biopharmaceutical enterprises, eight applied positions, including drug screening engineer, cell culture engineer, molecular biology technician, fermentation engineer, microorganism engineer, protein purification engineer, protein analysis technician and bio-preparation engineer, were then selected. According to the requirements of each position, 31 subjects were finally chosen from the above-mentioned 52 subjects that are involved in the life cycle of medicinal products. These subjects belong to four clusters and constitute the basis of the curriculum system for applied training of undergraduates of biopharmaceutical engineering. The results obtained from this work are expected to provide evidence for the training of biopharmaceutical students as well as the implementation of collaborative education between university and industry.

Application of Fenton Process in Industrial Wastewater Treatment Plant

In an industry zone wastewater treatment plant where bio-pharmaceutical enterprises are concentrated, the inlet water quality is far beyond the standard with poor biochemical purification ability. The Fenton treatment is mainly used to deal with refractory biodegradable CODcr, while flocculation by dosing chemicals is used to remove TP. In order to optimize the dosage of Fenton process, it was validated by laboratory test and productivity test respectively, and the cost of Fenton dosage was calculated. In this paper, the experimental process and results are described in detail, which provides the basis for the dosing of industrial wastewater treatment plants using Fenton process.

Protection &amp; Coordination of Pharmaceutical Safety Responsibility Based on TPL

By using the basic idea of logistics and supply chain management, this paper researches on Protection &amp; Coordination of Pharmaceutical Safety Responsibility Based on TPL. The result shows that:From the macro and micro perspectives, protection &amp; coordination of pharmaceutical safety responsibility play an important part in guaranteeing biopharmaceutical product safety, promoting biopharmaceutical enterprises' performance，strengthening supervision on biopharmaceutical product safety and advancing the service level of government supervision, which is also of guiding significance and practice value for high efficient operation and decision of biopharmaceutical supply chain.

China's National Torch Plan

Wuzhong District is located in the south of Suzhou and surrounded by Taihu Lake, the third largest lake in China. It was named a "National Torch Plan Wuzhong Pharmaceutical Industrial Base" in 2001 by the Ministry of Science and Technology of the People's Republic of China for its well-developed biopharmaceutical enterprises. It also earned the name of "Wuzhong Pharm Harbor" in the pharmaceutical industry. The company also strives to become a global player in providing good laboratory practice-compliant (GLP) drug safety evaluation preclinical services and pharmaceutical services by upgrading its infrastructure and GLP system to meet international standards, recruiting talent, and expanding service programs and capacity.

An exploratory analysis of the strategic marketing choices implemented by the UK biopharmaceutical SMEs

The biopharmaceutical sector has known a rapid expansion in the last 25 years. Starting from the late 1970s and early 1980s, a large number of entrepreneurial firms have been created by scientists or by business professionals. Unfortunately, the small firms have been confronted with a complex and hostile environment, characterised by high levels of competition, high risks and large costs for product research and development. In order to survive and develop, these firms have adopted specific strategies or combinations of strategies. This paper attempts to identify and analyse the strategic marketing options adopted by the UK biopharmaceutical enterprises, and the factors that influenced their decisions. Based on a comprehensive analysis of secondary and primary data, this study synthesises the research findings into a dynamic model for representing the firms' evolution in terms of strategic choice.

Flexible risk management in new product development: the case of small- and medium-sized biopharmaceutical enterprises

Risk is a characteristic of innovative industries. The process of new product development in the biopharmaceutical sector is extremely dynamic and unpredictable, creating both risks and opportunities for the small and medium-sized enterprises. The survival and development of these firms is determined by their capacity to develop flexible, but effective responses to the challenges of the competitive environment. This study investigates the risk management procedures implemented by the UK biopharmaceutical SMEs, and the importance of flexibility for enhancing risk management in the new product development process. On the basis of the data collected and interpreted, the study proposes a multi-level model of flexible risk management approach for biopharmaceutical firms.