Biopharmaceutical Companies Research Articles

The biopharmaceutical industry in Iran has made significant progress in recent years, supported by multiple innovation policies aimed at its development. Nevertheless, challenges such as limited resources, skill and managerial gaps, weak networking, and restricted access to funding and incentives have hindered sustainable innovation. This study aims to examine the role of intermediaries in supporting biopharmaceutical companies and to analyze how innovation policies influence technological capabilities, networking, human capital development, and access to funding and incentives in Iran. A qualitative approach was employed, using purposive sampling to select 19 participants from the governmental, academic, and industrial sectors. Data were collected through semi-structured interviews and analyzed using Braun and Clarke's six-step thematic analysis (2006). Data credibility and validity were ensured through member checking, triangulation, and independent coding by two researchers. The findings indicate that innovation policies have advanced across four main dimensions-exploitation of results and production, networking and facilitation, human capital, and funding and incentives-but each dimension faces specific challenges. Intermediaries, including accelerators, technology centers, industry associations, and specialized investment funds, play a key role in addressing these challenges by providing practical training, financial and technical support, facilitating cross-sector collaborations, and establishing professional networks, thereby fostering sustainable development and innovation in the biopharmaceutical sector. Strengthening intermediaries and implementing targeted policies based on companies' real needs can enhance the effectiveness of innovation policies, reduce import dependence, and improve the global competitiveness of Iran's biopharmaceutical industry.

Advancing value-based healthcare (VBHC) through collaborative innovation The UK NHS’s are all seeking sustainable, outcomes-driven care, adopting VBHC with its focus on better patients outcomes relative to cost: an approach underpinning the recent 10 year plan for England. A joint project between an International Biopharmaceutical Company and Swansea University explored effective collaboration for successful VBHC implementation. As healthcare systems around the globe deal with growing complexity, ageing populations, and escalating costs, the need for fundamental transformation has never been more urgent. In the UK, the National Health Service (NHS) faces similar pressures, prompting a renewed focus on delivering more sustainable, outcomes-driven care and has recently launched its 10 Year Health Plan for England with a vision of neighbourhood health centres, digital-first centres, and preventative care, and highlighted recently by the Health Innovation Southwest Network, CEO Jon Siddall that:

Industry reports indicate that small biopharmaceutical companies are increasingly launching their own new molecular entities, with first-time companies expected to represent the primary share of blockbuster product launches within the decade. However, company experience may affect the use of Food and Drug Administration (FDA) expedited programs, clinical development times, and FDA review times for new molecular entities and new biologics. Hence, we conducted a cross-sectional study examining all new molecular entity (NME) drug and new biologic approvals by the FDA from 2015 through 2022. Sponsors were categorized as first-time when the product represented their inaugural approval or followed their first approval by no more than 12 months. We extracted data on expedited program use (accelerated approval, breakthrough therapy, fast track, and priority review), first-cycle approval status, Prescription Drug User Fee Act (PDUFA) deadline achievement status, development and regulatory review timelines, and patent counts from public FDA data. From 2015 through 2022, 355 NMEs and new biologics were approved: 131 (36.9%) by first-time companies and 224 (63.1%) by experienced companies. The proportion of approvals attributed to first-time companies increased significantly over time (27.3% in 2015-2016 vs. 43.7% in 2021-2022; P = 0.04). Despite their lack of prior regulatory experience, there were no statistically significant differences in expedited program use, first-cycle approval rates, PDUFA deadline achievement rates, clinical development times, or patent counts between first-time and experienced companies. These findings suggest that first-time pharmaceutical companies appear to successfully navigate FDA regulatory processes as effectively as experienced firms.

Biopharmaceutical manufacturing processes in which the product of interest is extracellularly expressed typically employ a clarification step following cell culture or fermentation. During clarification, crude cell culture fluid or fermentation broth is processed to remove insoluble solids, cells, debris, and other particulates, with the extracellular product of interest retained in the filtrate. Soluble impurities, such as host cell proteins (HCPs), may also be partially removed. Historically, the clarification process has been considered a limited contributor to Critical Quality Attributes (CQA). As part of upstream harvest, many biopharmaceutical companies have not fully developed quality control strategies from process development to manufacturing, complicating the application of Quality by Design (QbD) principles to this step. However, advancements in upstream and downstream processing (DSP) technologies, alongside increasing cell counts and titers, necessitate reevaluating clarification as a critical process contributing to drug product quality. Conducting controlled studies to define the process and establish parameters using QbD principles can improve control over process impurities and facilitate a logical quality control strategy, integrating quality into the process. This article describes a systematic approach to QbD for a harvest clarification process where the product of interest is extracellular and impurities are removed in the filtrate post-clarification. It highlights methods for optimizing the clarification unit operation using QbD principles, ensuring better process efficiency, and product quality.

The rapid advancement of cell and gene therapies (CGT) in the past ten years has inspired biopharmaceutical companies, biotechnologies, and nonprofits to tackle diseases that have traditionally been challenging to treat. Rare diseases, where roughly 80% have a genetic basis, have enjoyed this scrutiny, but the complexity of CGT trial design and implementation have proven challenging. This manuscript offers general guidance for CGT clinical development, current regulatory requirements and guidelines governed by FDA and EMA, considerations around preclinical development, safety monitoring and the need for long-term monitoring and follow up.

Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating patient access.

Conflicts of interest (COIs) between clinical trial investigators and biopharmaceutical companies have raised concerns about potential bias in research. This study aimed to systematically analyze the prevalence and trends of COIs in oncology clinical trials published in the Journal of Clinical Oncology (JCO) for the past 15 years and to demonstrate the utility of large language models (LLMs) for automated data extraction in this context. We identified clinical trials published in the JCO from 2010 to 2025 using PubMed. We extracted publication data and author disclosures from the JCO Web site. OpenAI's GPT-4o was used to identify the main medical product studied and the related biopharmaceutical company and their variants in author disclosures. We then analyzed COI trends across three time periods (2010-2015, 2015-2020, 2020-2025). GPT-4o demonstrated close to 95% accuracy in identifying medical products and companies. Of the 2,583 clinical trials, 2,219 (85.9%) involved a medical product. Among these, 1,610 (72.6%) had at least one author with a COI related to the associated biopharmaceutical company. COI prevalence increased from 70.0% (2010-2015) to 77.0% (2015-2020), and then decreased to 72.0% (2020-2025). Company employment, advisory roles, and honoraria were common COI types and followed similar trends. US-led studies had a significantly higher COI prevalence than those from other regions (77.6% v 67.3%; P < .001). Additionally, 61.9% of first or last authors had a COI, which increased consistently over three time periods. This study reveals widespread COIs in oncology clinical trials, particularly in US-led studies and among leading authors, with discernible temporal patterns. The LLM-based method provides an efficient solution for COI monitoring, promoting transparency in biomedical research.

Globalization of Alzheimer's disease clinical trials: Current characteristics and future goals.

Targeting intracellular mRNA m6A-modifiers in advancing immunotherapeutics.

This study investigates the IPO strategy models of Innovent Biologics and Genor Biopharma, two major Chinese biopharmaceutical companies. The two companies are also involved in the oncology and immune disease drugs and taking the 18A listing system of Hong Kong as capital entry point to support their R&amp;D-centered businesses. Innovent Biologics pursued an independent set of research and development projects, which attracted a wide range of investors and provided a stable post-IPO growth. On the other hand, Genor Biopharma used a hybrid approach and focused on a specific group of investors; however, this caused its stock value to fluctuate. The findings of the study stress the roles of strategic planning, investor diversification, and innovation when it comes to biotech IPOs. The main takeaway is that maintaining an R&amp;D pipeline and having a diversified investor base creates positive sentiment and strengthens the future market perspective, all of which are invaluable tips for considering future biotech companies' listings.

With the continuous development of economic globalization, cross-border mergers and acquisitions have become an important means for enterprises to develop overseas business and increase market share. However, at present, as an emerging industry, biopharmaceutical companies have little experience in cross-border mergers and acquisitions and lack the ability in managing financial risks. Using the acquisition of F-star by China Biopharma as a case study, this paper focuses on the financial risks in cross-border M&amp;A and concludes that: first, financial risks vary across different stages in cross-border M&amp;A and demonstrate transitivity. Second, the core risks of cross-border M&amp;A in China Biopharma are pricing and financing risk in the preparation stage of M&amp;A. Third, leveraged financing in cross-border M&amp;A is characterized by high yield and high risk, and enterprises need to enhance their ability to control financial risks. Finally, based on this case study, suggestions are provided for pharmaceutical companies that carry out cross-border mergers and acquisitions.

Protein aggregates and insoluble particles in biopharmaceutical products are impurities that can elicit immunogenicity. The protein aggregates and insoluble particles form during manufacturing and storage, and should be characterized to optimize the manufacturing process and establish a control strategy. Several issues regarding the evaluation and control of these particles have been concerned, and collaborative studies have been conducted in the Japan Biopharmaceutical Consortium to address them. However, there is still no consensus for utilizing analytical techniques in parallel to establish a control strategy for such protein aggregates and insoluble particles, which range in size from a few nanometers to several hundred micrometers. Therefore, in this study, we surveyed Japanese biopharmaceutical companies through a questionnaire including questions regarding analytical techniques used to establish control strategies for protein aggregates and insoluble particles at various development phases. To summary the survey results, we found that size exclusion chromatography, light obscuration, and visual inspection are consistently used from early development and formulation optimization stage to commercial manufacturing. Apart from the light obscuration method, flow imaging (FI) was the most commonly used technique for subvisible particle characterization; thus, the use of FI to establish a control strategy was documented. The recommendation for establishing a control strategy for protein aggregates and insoluble particles based on life-cycle of drug development are summarized.

Genomic sequencing of tumours improves patient outcomes through implementation of precision oncology. At present, genomic testing is mainly confined to research settings, with samples sent to biopharmaceutical companies for analysis. The ever-expanding catalogue approved of targeted therapies has created an urgent unmet need for local genomic testing facilities, to enable upscaling of testing. Here, we compare the outcomes of local (IonTorrent™) and commercial (Foundation Medicine) genomic testing collected from 30 cancer patients in from plasma and tissue samples. Overall concordance was high in both tissue (98%) and plasma (94.2%). Variants identified by both platforms had a strong correlation in variant allele frequencies (VAF%): plasma: r = 0.99 p < 0.0001, tissue: r = 0.91 p < 0.0001. However, numerous low VAF% variants resulted in low positive percentage agreement (tissue 78.8% plasma 16.1%) and positive predictive values (tissue 56.3% plasma 71.4%). Local sequencing demonstrated higher fidelity in detecting fusions but low fidelity in detecting indels. Overall, this study supports the use of local genomic testing for routine molecular diagnostics but highlights outstanding issues before widespread implementation. Processing of variants detected at low VAF% and the limit of detection of assays needs to be addressed. Construction of gene panels requires careful consideration, including incorporation of markers of genomic instability.

Biopharmaceutical companies generate a wealth of data, ranging from in silico physicochemical properties and machine learning models to both low and high-throughput in vitro assays and in vivo studies. To effectively harnesses this extensive data, we introduce a statistical methodology facilitated by Accuracy, Utility, and Rank Order Assessment (AURA), which combines basic statistical analyses with dynamic data visualizations to evaluate endpoint effectiveness in predicting intestinal absorption. We demonstrated that various physicochemical properties uniquely influence intestinal absorption on a project-specific basis, considering factors like intestinal efflux, passive permeability, and clearance. Projects within both the "Rule of 5" (Ro5) and beyond "Rule of 5" (bRo5) space present unique absorption challenges, emphasizing the need for tailored optimization strategies over one-size-fits-all approaches. This is corroborated by the improved accuracy of project-specific correlations over global models. The differences in correlations between and within project teams-due to their unique chemical spaces-highlight how complex and nuanced the prediction of intestinal absorption can be. Here, we implement a standardized methodology, AURA, that any organization can incorporate into their workflow to enhance early-stage drug optimization. By automating analytics, integrating diverse data types, and offering flexible visualizations, AURA enables cross-functional teams to make data-driven decisions, optimize workflows, and enhance research efficiency.

This study investigates the impact of business area diversification across vertical and horizontal dimensions on the efficiency of Korean biopharmaceutical companies. Utilising data from 187 firms and 1,830 observations between 2015 and 2021, this study employs Stochastic Frontier Analysis (SFA) and Meta-Frontier Analysis to examine how diversification strategies influence firm efficiency. The results indicate that vertical diversification, particularly in high-value sectors like biopharmaceutical equipment, shows a strong potential for enhancing firm efficiency. On the other hand, the effects of horizontal diversification vary, with efficiency improvements depending on the level of diversification pursued by each company. These findings offer strategic insights for optimising business diversification in the Korean biopharmaceutical sector and guiding decision-making for long-term competitiveness.

Cost reduction through improvement in energy efficiency is a determining factor for the optimization of operational processes and the economic sustainability of organizations. One opportunity for achieving significant levels is by designing energy-efficient heating, ventilation, and air conditioning systems for new industrial facilities. Cleanrooms, used in biopharmaceutical companies, require high air change rates to maintain cleanliness, which are particularly energy intensive. This paper analyzed data collected from third-party sources, demonstrating a method used in a biopharmaceutical facility in Ireland. The study’s objective was to compute the parameters related to energy efficiency before and after fresh air volume control implementation, aiming to ascertain the effectiveness of this approach in optimizing energy consumption and ventilation performance. This case study analyzed 185 cleanrooms of different sizes and classifications; it was observed that all rooms exceeded the recommended air change per hour. The data indicated that rooms with higher volumes had greater energy waste, underscoring the importance of optimizing airflow management in large cleanroom environments. The implementation of fresh air volume control showed a reduction of 8.87% in fan energy consumption, equivalent to a decrease of 46,666 units of air change per hour annually. This decrease in units was accompanied by a substantial reduction in fan waste, amounting to 203,399.1 kWh, and saving more than €49,055.8 per year using pressure gradient control strategies in the ventilation system. Overall, the present work provides insights into improving energy efficiency in the biopharmaceutical industry and highlights the economic and energy-saving benefits associated with implementing the proposed method. Furthermore, it offers a practical solution to reduce operational costs and environmental impact while maintaining stringent cleanliness standards, essential for cleanroom operations.

This study aims to establish a cost basis for biologics manufacturers and policymakers by quantifying the price and time required to bring a biosimilar from the lab to market. For efficient implementation of a cost-based policy, especially for life-saving medicines like biosimilars, it is imperative to establish a benchmark for the cost involved in biosimilar development. In this holistic and multiple-case study, stage-wise cost estimates of biosimilar development were obtained for microbial and mammalian systems. The investigation of six biopharmaceutical companies based in India concluded that biosimilar development through the microbial system costs ∼18 million USD and ∼21 million USD for the mammalian system. Additionally, 45-50 million USD is required as a one-time capital investment. Further, US/EU authorization can cost ∼25 million USD per product. Clinical studies are the most expensive and account for 60%-70% of total development cost. The presented information can serve as a basis for implementing cost-based pricing in countries like India and reimbursement policies for biosimilars under Medicare Part B in the United States.

한·중 바이오 제약기업 종업원의 조직후원인식이 이직의도에 미치는 영향: 직무만족과 조직몰입의 매개효과

Historically, vaccine development has been heavily supported by government and public institutions. On the other hand, private biopharmaceutical companies have played a significant role in the development of innovative new therapies using novel pharmaceutical technologies. COVID-19 vaccines using new vaccine technologies, such as mRNA and adenoviral vectors, were rapidly developed by emerging biopharmaceutical companies in collaboration with large corporations and public organizations. This underscores the crucial role of emerging biopharma and public-private partnerships in advancing new vaccine technologies. While these innovations have been suggested as models for future vaccines, their applicability to other infectious diseases requires careful assessment. This study investigated the characteristics of the developers and partnerships in the development of DNA vaccines as a next-generation vaccine platform. The analysis revealed that while emerging biopharmaceutical companies and private-private and private-public partnerships were crucial during the COVID-19 pandemic, public organizations and public-public collaborations primarily led to the clinical development of vaccines for other diseases. Strategies for vaccine development using new vaccine technologies should be tailored to the specific characteristics of each disease.

In this article the problem of discoverability and abductive creativity in scientific cognition will be characterized by the analysis of current difficulties that affect various aspects of the scientific enterprise such as in the case of the organization of Research and Development in biopharmaceutical companies. I will contend that this case symbolizes a paradigmatic example of what I have called “impoverished epistemic niches” in which it seems that some of the fundamental aspects that qualify modern science are jeopardized. To refer to some recent challenges to the crucial role played in scientific abductive cognition by the so-called “maximization of eco-cognitive openness” and “optimization of eco-cognitive situatedness”, I will propose the new concept of “epistemic irresponsibility”. I will emphasize the importance of the so-called knowledge in motion – in multidisciplinary, interdisciplinary, and transdisciplinary scientific research: the concept of knowledge in motion is also the necessary conceptual premise of the analysis of various kinds of epistemic irresponsibility. I indeed will illustrate the current increasing expansion of commodification and commercialization of science, marketing of technoscientific products, impoverishment of the epistemic niches, showing that a consequence is and could further be an attack to the possibility of a further flourishing of human fecund and successful abductive creative cognition in science, and so at the same time human creativity severely compromised.