Biotechnology Research Articles

Bench-Scale Stirred-Tank Bioreactor for Recombinant Protein Production in Chinese Hamster Ovary (CHO) Cells in Suspension.

Most pharmaceutical biotechnology companies use stirred-tank bioreactors (STR) for recombinant protein manufacturing. These bioreactors are used at a variety of different scales ranging from bench to production scales, with working volumes from 10mL to 25,000L. Bench-scale STRs are commonly used to culture mammalian cells for process development, to troubleshoot production scale bioreactors using scale-down models (SDM), or to conduct fundamental research. In this chapter, we describe the operations of a bench-scale STR for the production of recombinant proteins with suspension-adapted Chinese hamster ovary (CHO) cells. These operations include bioreactor setup and configuration, batching media, inoculation of the seed cell culture, production phase, and harvest of cell-free fluids.

Towards biotechnological production of bio-based low molecular weight esters: a patent review.

Low molecular weight (LMW) esters, like ethyl acetate, methyl formate or butyl acetate, are widespread bulk chemicals in many industries. Each of them is currently produced in huge amounts (millions of tons per year scale) starting from fossil-based feedstock and they are used mainly because of their low toxicity and complete biodegradability. Energy transition is just half of the story on the path of fighting climate change: 45% of the global greenhouse gas emissions are caused by the production and use of all the products, materials and food necessary for modern human life. If the world is to reach its climate goals, there is the need to leave underground a significant proportion of the fossil feedstock and minimize environmental impacts of chemical manufacturing. This is the reason why a lot of efforts have been made to find novel routes for LMW esters production starting from renewable raw materials (e.g. biomasses or off-gases) and exploiting low-impact manufacturing, such as microbial fermentation or enzymatic reactions. This review reports the most significant patents, in the field of white biotechnology, that will hopefully lead to the commercialization of bio-based LMW esters as well as novel strategies, current problems to be solved, newer technologies, and some patent applications aiming at possible future developments.

Development of antibody-drug conjugates in cancer: Overview and prospects.

In recent years, remarkable breakthroughs have been reported on antibody-drug conjugates (ADCs), with 15 ADCs successfully entering the market over the past decade. This substantial development has positioned ADCs as one of the fastest-growing domains in the realm of anticancer drugs, demonstrating their efficacy in treating a wide array of malignancies. Nonetheless, there is still an unmet clinical need for wider application, better efficacy, and fewer side effects of ADCs. An ADC generally comprises an antibody, a linker and a payload, and the combination has profound effects on drug structure, pharmacokinetic profile and efficacy. Hence, optimization of the key components provides an opportunity to develop ADCs with higher potency and fewer side effects. In this review, we comprehensively reviewed the current development and the prospects of ADC, provided an analysis of marketed ADCs and the ongoing pipelines globally as well as in China, highlighted several ADC platforms and technologies specific to different pharmaceutical enterprises and biotech companies, and also discussed the new related technologies, possibility of next-generation ADCs and the directions of clinical research.

Pharmaceutical Market: An Overview

Drug display has a substantial risk in terms of the investigation, occurrence, outcomes, and distribution of drugs generally. It is a dynamic and error-prone aspect of the healthcare production process. An overview of pharmaceuticals is provided in this abstract, with emphasis on their key traits, challenges, and methods.The pharmaceutical industry offers a vast array of brands, including generic drugs, biologics, vaccines, formula drugs, and investments in corporate cures. This is due to the ongoing advancements in science and biological research, as well as the growing demand for realistic scenarios in a range of medical contexts One of the trademarks of pharmaceutical presentations (R&D) is the allure of a significant reliance on testing. It takes a long time, money, and uncertainty to bring a new drug to market. It requires stringent preclinical and objective testing, supervisory permissions, and post-shopping follow-ups to ensure security and efficacy. Patents shield innovations and grant pharmaceutical companies a fenestella of uniqueness that helps them recover their large R&D expenses. However, this industry faces many challenges. Increasing healthcare costs, a rise in regulatory investigations, and pressure from payers and governments on prices have all contributed to a cost curb. In addition, there are still problems with research and development because of the rise in complicated diseases, antibiotic resistance, and the need for integrated healthcare. A shift toward biopharmaceuticals, digital healthcare, and precise therapies are just a few of the noteworthy themes that pharmaceutical advertising has helped to foster recently. The COVID-19 pandemic has increased the number of cure cases, revealing the manufacturing industry's susceptibility to pervasive health crises. Drug display is quite competitive, with minor biotech companies and two multinational alliances vying for market share. To expand device portfolios and gain access to new sciences, partnerships, acquisitions, and mergers are the most common approaches

Prototyping an ionization source for non-engineers.

Novel mass spectrometry (MS) based analytical platforms have enabled scientists to detect and quantify molecules within biological and environmental samples more accurately. Novel MS instrumentation starts as a prototype and, after years of development, can become a commercial product to be used by the larger MS community. Without the initial prototype, many MS-based instruments today would not be produced. Additionally, biotechnology companies are the main drivers for research, development, and production of novel instruments, but the tools for prototyping instrumentation have never been more accessible. Here, we present a tutorial on prototyping instrumentation through the case study of developing the Next Generation IR-MALDESI source to show that an engineering degree is not required to design and construct a prototype instrument with modern hardware and software. We discuss the prototyping process, the necessary skills required for efficient prototyping, and information about common hardware and software used within initial prototypes.

Do information disputes work: the effect of perceived risk, news disputes and credibility on consumer attitudes and trust toward biotechnology companies

PurposeThis study examines a controversial issue (biotechnology) and how news disputes about misinformation related to the issue impacts individuals' attitudes toward a biotechnology company and their trust in the media source.Design/methodology/approachThis study conducts a 2 (risk: low vs. high) x 2 (pre-existing attitude: anti gene-editing technology vs. pro gene-editing technology) x 2 (dispute message: absent vs. present) x 2 (media source: Buzzfeed vs NYT) factorial online experiment using a Qualtrics panel (N = 1,080) to examine the impact on individuals' attitudes toward a biotechnology company and trust in the media source.FindingsResults indicate that dispute messages enhance attitudes toward the company but decrease trust in media sources. Interaction effects between pre-existing attitude and the dispute message, along with perceived risk and the dispute message, illustrate stark differences in how individuals with favorable vs. unfavorable pre-existing attitudes assessed the company after viewing the dispute message.Originality/valueThis study applies arguments from extant literature about prebunking and debunking misinformation. Specifically, this study investigates how dispute messages, a form of debunking through source derogation, actually impact individuals' perceptions of media credibility and/or their attitudes about the content they are reading. The study findings also reveal new insights regarding the interaction between pre-existing attitudes and perceived risk, as well as how dispute messages interact with each of the aforementioned factors.

Advancing Inclusive Research (AIR) Site Alliance: Facilitating the inclusion of historically underrepresented people in oncology and ophthalmology clinical research

BackgroundThe Advancing Inclusive Research (AIR) Site Alliance is composed of clinical research centers that partner with Genentech, a biotechnology company, to advance the representation of diverse patient populations in its oncology and ophthalmology clinical trials, test recruitment, and retention approaches and establish best practices to leverage across the industry to achieve health equity. MethodsThrough a data-driven selection process, Genentech identified 6 oncology and 3 ophthalmology partners that focus on reaching historically underrepresented patients in clinical trials and worked collaboratively to share knowledge and explore original ways of increasing clinical study access for every patient, including sites co-creation of a Protocol Entry Criteria Guideline with inclusion principles. ResultsFor patients, three publicly available educational videos about clinical trials were created in multiple languages. The AIR Site Alliance has also defined invoiceable services for sites to enhance patient support; this has been built into the new study budget templates for sustainability. For healthcare professionals (HCPs), the first-of-its-kind AIR Educational Program was developed to focus on identifying and addressing bias and engaging historically underrepresented patient populations in trials. The sites also co-created videos for HCPs and patients on why advancing inclusive research matters. Over 16 regional health equity symposia have been delivered for patients, HCPs, and community leaders. ConclusionsThis AIR Site Alliance is a model for other site alliances, including Kenya, South Africa, the United Kingdom, and Canada. Such alliances will build a robust and sustainable research ecosystem that includes diverse patient groups and encourages change across the healthcare system.

Impact of Capacity Building Programmes on Farmers of Hassan District of Karnataka, India

The study was conducted in 5 villages of Channarayapattanataluk of Hassan district in Karnataka. The College of Agriculture, Hassan, Karnataka has conducted Rural Agricultural Work Experience Programme for the final year B.Sc (Hons.) Agriculture, B.Tech (Bio Technology) and B.Tech (Food Technology) in those 5 villages during the year 2021-22 for 3 months. The regular capacity building programmes were organized for the farmers by the students in the presence of scientists of the college. During the capacity building programmes such as training, method demonstration, exposure visits etc., the pre and post evaluation was also done to understand the knowledge and skill of the farmers about the bio agents and its application in crop production. The data was collected from 100 farmers to assessimpact of capacity building programmes on bio agentssuch as Trichoderma, Pseudomonas, Phosphate Solubilizing Bacteria etc. Thestudy reveals that, majority (78.00%) of the farmers were not aware about the availability of different bio agents in the market, 80.00 per cent of them were unaware about the importance of application of bio agents in crop production, around 89.00 per cent were not having knowledge about use of bio agents in different crops. Nearly 90.00 per cent of farmers were having poor knowledge and skill on how to use the bio agents in crop production practices. After the pre evaluation the different programmes like training programmes about the importance and application of bio agents, skill on demonstration about the bio agents treatment, exposure visits etc., were organized and conducted post evaluation also. The data from the study reveals that, there was increase in the knowledge level and skill in the application of bio agents to an extent of 25 to 30 per cent among the participants. During the year 2022, the study was conducted to assess the adoption level of farmers in the same villages about the importance and application of bio agents in their crop production practices. It was observed that, still farmers were using the bio agents in their farming practices and they were happy to share that, there was a good result in crop yield due to non incidence of pest and diseases and also due to reduced cost of pesticide application.

Strategic Financial Risk Management: Implementing the COSO-ERM Framework at ABC Biotech Company

This paper explores financial risk management through the lens of the COSO-ERM framework at ABC Biotech Company. It emphasizes the integration of risk management with corporate governance, strategy, and performance. Key aspects of the COSO-ERM framework, including Governance and Culture, Strategy and Objective Setting, Performance, and Information Communication and Reporting, are examined. The study delves into ABC Biotech's implementation of COSO-ERM, covering strategies for risk management, corporate strategy alignment, risk identification, and assessment enhancements. It underscores the importance of financial risk management as a dynamic, cyclical process aligned with strategic corporate growth, illustrating the framework's effectiveness in managing financial risks at ABC Biotech Company.

PT26 How Aware Are Biotech and Pharmaceutical Companies of the Implementation of the New EU HTA?

PT26 How Aware Are Biotech and Pharmaceutical Companies of the Implementation of the New EU HTA?

Preface

Preface

Advances in cardiac tissue engineering and heart-on-a-chip.

Recent advances in both cardiac tissue engineering and hearts-on-a-chip are grounded in new biomaterial development as well as the employment of innovative fabrication techniques that enable precise control of the mechanical, electrical, and structural properties of the cardiac tissues being modelled. The elongated structure of cardiomyocytes requires tuning of substrate properties and application of biophysical stimuli to drive its mature phenotype. Landmark advances have already been achieved with induced pluripotent stem cell-derived cardiac patches that advanced to human testing. Heart-on-a-chip platforms are now commonly used by a number of pharmaceutical and biotechnology companies. Here, we provide an overview of cardiac physiology in order to better define the requirements for functional tissue recapitulation. We then discuss the biomaterials most commonly used in both cardiac tissue engineering and heart-on-a-chip, followed by the discussion of recent representative studies in both fields. We outline significant challenges common to both fields, specifically: scalable tissue fabrication and platform standardization, improving cellular fidelity through effective tissue vascularization, achieving adult tissue maturation, and ultimately developing cryopreservation protocols so that the tissues are available off the shelf.

A novel sophorolipids extraction method by yeast fermentation process for enhanced skin efficacy.

Oriental herbs have been used as medicines in the folk remedy for their numerous phytochemicals and bioactivities. In this study, we have selected five Korean traditional medical herbs and applied bio conversion extraction technology, named it as Bioconversion Oji complex, to identify phytochemicals and evaluate skin related efficacies. The process of two-step bio conversion was sequentially conducted. The first step of fermentation was to produce biosurfactants using macadamia seed oil with Candida bombicola, and then five natural plants were added to carry out the main fermentation. To evaluate skin improvement efficacy of Bioconversion Oji complex, in vitro and in vivo studies were conducted. We studied HaCaT cells cultured to assess viability, skin anti-inflammatory, moisturizing and barrier improvement-related mRNA expression. For efficacy study, 21 participants were tested evaluating anti-inflammatory, skin moisturizing and skin barrier improving effects of Bioconversion Oji complex compared to Water extraction of Oji (placebo) for the 4 weeks test period. The application of bioconversion technology highly increased the content of amino acids and lipids within Bioconversion Oji complex, and 23 flavonoids were also identified. Bioconversion Oji complex was found to be non-toxic and showed significant effects in all parameters tested, including anti-inflammation, skin moisture, and skin barrier in both in vitro and in clinical studies. Bioconversion Oji complex has demonstrated skin-friendly properties with significant beneficial effects on anti-inflammatory, skin hydration and barrier function properties. This study provides evidence for the use of Bioconversion Oji complex as an active ingredient in cosmetics and skincare products.

When mRNA technology meets patent law: innovation, barriers and public health

Abstract The success of messenger ribonucleic acid (mRNA) technology during the Coronavirus disease (COVID-19) pandemic has ushered in a new era of vaccine and therapeutic development. In this rapidly evolving field, top biotech and biopharma companies are constantly searching for new opportunities to create innovative treatments and vaccines. However, the landscape of mRNA patents is getting complicated and dense, with an accumulation of partially overlapping patent rights that require multiple rights holders’ permission for use and commercialization. Additionally, there are several pending patent lawsuits related to key components of mRNA platform technologies, with strong implications for follow-on innovation and technology diffusion within the field. The case of mRNA technology—as often happens with emerging technologies—is therefore emblematic of the policy dilemma faced by patent law of how to balance economic incentives in a setting of cumulative innovation. This article maps out relevant legal factors that, under different conditions, might aggravate or mitigate the potential negative effects of patents in the field. Further, it sets a framework for more targeted examination of the identified issues.

Dog-mediated rabies, an increasing threat to families in Kenema district: A call for action

On 5th December 2022, a stray dog attacked and bit five children, aged between 6 to 10 years in the same community in Kenema District. The children suffered multiple wounds on their bodies and were rushed to the hospital for treatment. The dog was killed, head decapitated and submitted to the Central Veterinary Laboratory/Teko, in Makeni, Bombali District, for confirmation of rabies. The sample was confirmed positive using a direct fluorescent antibody test. The victims of the dog attack were rushed to the Kenema Regional Hospital for treatment. Due to the high cost of the rabies post-exposure prophylaxis (PEP) vaccine (rabies vaccine freeze-dried from Liaoning Cheng Da Biotechnology Company Limited (SPEEDA®)), the families could not afford the whole cost of treatment. The victims were only able to receive the first dose of post-exposure vaccination which cost Le 400 per dose (US$ 20.5 equivalent). Upon the intervention of the Ministry of Agriculture and Food Security, the children received the complete dose. This is just one among many unreported cases of exposure to dog-mediated rabies within the country.

Evaluating the impact of the FDA’s orphan drug designation on share prices of biotechnology companies

This analysis explores the impact of the FDA's orphan drug designation (ODD) on biotechnology companies' share prices in the short and long term. Our analysis reveals that there is a significant immediate increase in share prices following an ODD announcement, which underscores its potential as a robust indicator of short-term investor returns. However, the long-term findings present a more complex picture, with a sustained impact within the biotech industry but a significant depreciation against the broader market over time. These findings elucidate the nuanced effects of regulatory milestones on the financial performance of pharmaceutical companies and highlight the need for more comprehensive studies to further unravel these complex dynamics.

Ectopic expression of insulin in a type 1 diabetic rat model by injection of manipulated mesenchymal stem cells with an insulin construct driven by a glucose-sensitive promoter in the port vein.

The treatment of type 1 diabetes through islet cell transplantation is a complex process, facing challenges such as allograft rejections and a limited supply of donors. One potential solution is to utilize the liver as an alternative for natural insulin production, as hepatocytes can secrete proteins and respond to glucose levels. Recent research has shown promising results in using mesenchymal stem cells as a potential cure for diabetes. The study utilized a diabetic rat model, confirmed through blood sugar measurement. A plasmid vector was designed with specific genetic components, synthesized by biotech company, and then Inserted vector into a plasmid with resistance genes and bacterial origin. Bone marrow-derived mesenchymal stem cells (BM-MSCs) were cultured and transfected with the plasmid using Lipofectamine 3000. Polymerase chain reaction wasemployed to confirm successful transfection using specific primers. For the animal study, 30 male Wistar rats were divided into six groups, each comprising five rats. The control group did not receive any treatment, while the second group received MSCs via Portal Vein Injection. The third group received MSCs transfected with a specific construct via Portal Vein Injection. The fourth group was induced to develop diabetes through streptozotocin(STZ) injection, the fifth group developed diabetes and received untransfected MSCs via Portal Vein Injection, and the sixth group received MSCs transfected with the specific construct via Portal Vein Injection. To manage Pain, appropriate pain control was administered to the rats for 3 days after the surgery. Fixed liver tissues obtained from the euthanized rats were utilized for immunohistochemistry. In this study, immunohistochemical techniques were used to examine insulin expression in different groups of rats. The control groups showed high levels of insulin expression, while the diabetic groups exhibited lower expression. However, there was a significant difference between the diabetic groups treated with MSC and transgenic MSC cells. All groups had similar baseline glucose levels, but the diabetic groups showed a significant increase after STZ injection, whereas the control and MSC groups did not. Postintervention, both the control and MSC groups had similar glucose levels to the post-STZ levels. However, diabetes-induced groups experienced a significant decrease in glucose levels, with the transfected MSCs showing a greater decrease than the untransfected MSCs. The study suggested that treatment with MSCs, especially transfected ones, can effectively reduce glucose levels in rats with diabetes. In this research, rat BM-MSCs were utilized to create insulin-producing mesenchymal cells with glucose-sensitive insulin expression. The cells were transferred to the liver of diabetic rats via portal vein injection, leading to an increase in insulin expression. This study proposes a novel approach for cell therapy and delivery in the treatment of type 1 diabetes.

Risk and return in the biotech industry

PurposeBiotech companies stand as key actors in pharmaceutical innovation. The high risk and long timelines inherent with their R&D investments might hinder their access to funding, potentially stifling innovation. This study aims to explore into the appeal of biotech companies to capital market investors, whose financial backing could bolster the growth of the biotechnology sector.Design/methodology/approachThis paper uses a dataset of 774 US publicly listed biotech firms to investigate their risk and return characteristics by comparing them to pharmaceutical firms and a sample of matched non-biotech R&D-intensive firms over the sample period 1980–2021. Tests show that the conclusions remain consistent across diverse methodological approaches.FindingsThe paper shows that biotech companies are riskier than the average firm in the market index but outperform on a risk-adjusted basis both the market and a matched group of R&D-intensive firms. This is particularly true for large capitalization biotech, which is also shown to provide a diversification benefit by reducing the downside risk in past crisis periods.Originality/valueThis paper provides insight relevant to the current debate about the overall performance of the biotech industry in terms of policy changes and their impact on small, early-stage biotech firms. While small and early-stage biotech firms are playing an increasing role in scientific innovation, this study confirms their greater vulnerability to financial risks and the importance of access to capital markets in enabling those companies to survive and evolve into larger biotech.

How to fix a broken heart-designing biofunctional cues for effective, environmentally-friendly cardiac tissue engineering.

Cardiovascular diseases bear strong socioeconomic and ecological impact on the worldwide healthcare system. A large consumption of goods, use of polymer-based cardiovascular biomaterials, and long hospitalization times add up to an extensive carbon footprint on the environment often turning out to be ineffective at healing such cardiovascular diseases. On the other hand, cardiac cell toxicity is among the most severe but common side effect of drugs used to treat numerous diseases from COVID-19 to diabetes, often resulting in the withdrawal of such pharmaceuticals from the market. Currently, most patients that have suffered from cardiovascular disease will never fully recover. All of these factors further contribute to the extensive negative toll pharmaceutical, biotechnological, and biomedical companies have on the environment. Hence, there is a dire need to develop new environmentally-friendly strategies that on the one hand would promise cardiac tissue regeneration after damage and on the other hand would offer solutions for the fast screening of drugs to ensure that they do not cause cardiovascular toxicity. Importantly, both require one thing-a mature, functioning cardiac tissue that can be fabricated in a fast, reliable, and repeatable manner from environmentally friendly biomaterials in the lab. This is not an easy task to complete as numerous approaches have been undertaken, separately and combined, to achieve it. This review gathers such strategies and provides insights into which succeed or fail and what is needed for the field of environmentally-friendly cardiac tissue engineering to prosper.

СТАБІЛЬНИЙ РОЗВИТОК БІОТЕХНОЛОГІЧНОГО ВИРОБНИЦТВА В КРИЗОВИХ УМОВАХ

The article examines the peculiarities of risks for the biotech production development in Ukraine and in the world. Biotechnological production, especially in the agricultural sector, has always been and remains the most vulnerable to military operations, social unrest, natural disasters, extraordinary events, etc. Considering the insufficient use of the biotechnological production potential of Ukraine, special attention should be paid to the development of this industry with planned provision of stable development both during the war and after its end. Global trends in sales volumes of shares of innovative biotechnological companies were analyzed. As for Ukraine, in 2021, the investment and innovation activities of agricultural producers intensified and reached a maximum result of 2.5 billion dollars. USA, which is one of the best results during the years of Ukraine's independence. in recent years, the total amount of capital investment per hectare of land was from 70 to 100 dollars. USA. Protest, according to economists, only under the conditions of capital investments from USD 150. US/ha, it can be argued that the country is developing in the direction of innovation and investment modernization. The article identifies groups of main risks for biotechnological industries in Ukraine and the world. It is possible to increase the volumes of state support for biotechnological production in the agricultural sector and the attraction of private investments, which is especially relevant in crisis conditions and global uncertainty. Stable development of biotechnological production in Ukraine is possible through digitization and automation of management and production processes, as well as taking into account all the risks inherent in this field.