Biotechnology Research Articles

The Financial Derivatives Market and the Pandemic: BioNTech and Moderna Volatility

Global society’s comfort and well-established certainties have been unpredictably and foundationally undermined by the emergence of the COVID-19 virus. The announcement of the pandemic by the WHO has halted global economic activities, and the financial markets have recorded drastic losses. In this context of uncertainty and economic downturn, many traditional companies have been negatively impacted, but the biotechnology sector, which has already been growing for some years, registered high growth rates and earnings. In particular, this study focused on the two most significant biotech companies, BioNTech and Moderna, the two start-ups that first commercialized COVID-19 vaccines. The GARCH (1,1) model examines the relation of two stock prices and the volatility of derivatives markets before and after the outbreak of the pandemic. The variables used in the analysis are the U.S. technologic market index, the market volatility, and Brent future prices. The results suggest a different reaction of market volatility and Brent future prices on the return of both companies. Additionally, during the COVID-19 period, a contagion effect between both companies and the technological market was observed.

Personalized neoantigen cancer vaccines: An analysis of the clinical and commercial potential of ongoing development programs

Neoantigen cancer vaccines harbor promise as next-generation immuno-oncology therapies, whereby cancer vaccines are tailored to the patient's tumor antigen and represent the future of personalized cancer therapy. While several biotech companies have ongoing development programs, little has been published about the true commercial potential of these innovative therapies and the challenges these products will face upon regulatory approval. In this paper, we provide an overview of neoantigen cancer vaccine development programs and discuss the commercial environment these therapies will face upon launch.

ChatGPT or LLM in next-generation drug discovery and development: pharmaceutical and biotechnology companies can make use of the artificial intelligence-based device for a faster way of drug discovery and development.

ChatGPT or LLM in next-generation drug discovery and development: pharmaceutical and biotechnology companies can make use of the artificial intelligence-based device for a faster way of drug discovery and development.

Research on the Status Quo and Technology Evaluation of Innovation and Development of Chinese Biotechnology Companies

The biotechnology industry is currently a sunrise industry closely related to human health and life safety. Through the relevant analysis of Chinese biotechnology enterprise innovation, it is found that, for enterprise innovation, there is still little research on technology selection and evaluation. Technological innovation is the most critical and the main driving force for the development of biotechnology enterprises, and the level of technological innovation determines the development level and potential of enterprises. Based on the relevant characteristics of biotechnology, this paper studies issues such as technology evaluation, technology selection, and enterprise innovation in biotechnology. As a result, the relevant characteristics of modern biotechnology are systematically researched and summarized in this paper, laying a foundation for further in-depth research on modern biotechnology management. At the same time, the evaluation and selection model of relevant modern biotechnology is also established, which has strong guiding significance for coping with the high uncertainty of modern biotechnology.

The downstream bioprocess toolbox for therapeutic viral vectors

Viral vectors are poised to acquire a prominent position in modern medicine and biotechnology owing to their role as delivery agents for gene therapies, oncolytic agents, vaccine platforms, and a gateway to engineer cell therapies as well as plants and animals for sustainable agriculture. The success of viral vectors will critically depend on the availability of flexible and affordable biomanufacturing strategies that can meet the growing demand by clinics and biotech companies worldwide. In this context, a key role will be played by downstream process technology: while initially adapted from protein purification media, the purification toolbox for viral vectors is currently undergoing a rapid expansion to fit the unique biomolecular characteristics of these products. Innovation efforts are articulated on two fronts, namely (i) the discovery of affinity ligands that target adeno-associated virus, lentivirus, adenovirus, etc.; (ii) the development of adsorbents with innovative morphologies, such as membranes and 3D printed monoliths, that fit the size of viral vectors. Complementing these efforts are the design of novel process layouts that capitalize on novel ligands and adsorbents to ensure high yield and purity of the product while safeguarding its therapeutic efficacy and safety; and a growing panel of analytical methods that monitor the complex array of critical quality attributes of viral vectors and correlate them to the purification strategies. To help explore this complex and evolving environment, this study presents a comprehensive overview of the downstream bioprocess toolbox for viral vectors established in the last decade, and discusses present efforts and future directions contributing to the success of this promising class of biological medicines.

Promises and challenges of a decentralized CAR T-cell manufacturing model.

Autologous chimeric antigen receptor-modified T-cell (CAR T) products have demonstrated un-precedent efficacy in treating many relapsed/refractory B-cell and plasma cell malignancies, leading to multiple commercial products now in routine clinical use. These positive responses to CAR T therapy have spurred biotech and big pharma companies to evaluate innovative production methods to increase patient access while maintaining adequate quality control and profitability. Autologous cellular therapies are, by definition, manufactured as single patient batches, and demand has soared for manufacturing facilities compliant with current Good Manufacturing Practice (cGMP) regulations. The use of a centralized production model is straining finite resources even in developed countries in North America and the European Union, and patient access is not feasible for most of the developing world. The idea of having a more uniform availability of these cell therapy products promoted the concept of point-of-care (POC) manufacturing or decentralized in-house production. While this strategy can potentially decrease the cost of manufacturing, the challenge comes in maintaining the same quality as currently available centrally manufactured products due to the lack of standardized manufacturing techniques amongst institutions. However, academic medical institutions and biotech companies alike have forged ahead innovating and adopting new technologies to launch clinical trials of CAR T products produced exclusively in-house. Here we discuss POC production of CAR T products.

A Novel Device for the Treatment of Rheumatoid Arthritis

Gerontechnological devices are technologies that can assist older adults to successfully and comfortably age in place, within their own homes. Xen is a new gerontechnological device created by Neuvana, a neuroscience and biotechnology company based in the United States. This small device is controlled by a mobile app and works to send electrical signals to the vagus nerve through an ear piece. Such stimulation activates the parasympathetic nervous system, thereby reducing inflammation throughout the body. As such, Xen by Neuvana may serve as a powerful new gerontechnological device that can be used by older adults to treat rheumatoid arthritis.

A bibliometric evaluation of the top 100 cited articles on ocrelizumab.

To analyze the 100 most cited articles (T100) on ocrelizumab using bibliometric methods to determine the current situation and identify research hotspots. Articles with "ocrelizumab" in their title were searched for in the Web of Science (WoS) database, identifying 900 articles. After the exclusion criteria were applied, 183 original articles and reviews were obtained. The T100 were selected from among these articles. Data on these articles (author, source, institution, country, scientific category, citation number, and citation density) were analyzed. The number of articles showed a fluctuating upward trend from 2006 to 2022. The total number of citations for the T100 ranged from two to 923. The average number of citations per article was 45.11. The most articles were published in 2021 (n=31). The "Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis" study (T1) was the most cited article among the T100 and had the highest annual average number of citations. T1, T2, and T3 were clinical trials on treating multiple sclerosis. The USA was the most productive and influential research country, with 44 articles. Multiple Sclerosis and Related Disorders was the most productive journal (n=22). Clinical neurology ranked first among the WoS categories (n=70). Hauser Stephen and Kappos Ludwig were the most influential authors, with 10 articles each. Biotechnology company Roche was at the top of the publication list, with 36 articles. This study's results can give researchers an idea about current developments and research collaborations on ocrelizumab. These data can help researchers easily obtain publications that have become classics. We conclude that the clinical and academic communities have shown a growing interest in ocrelizumab for treating primary progressive multiple sclerosis in recent years.

Major investment signals keen interest in psychedelics for mental health care

This month's announcement of up to $285 million in private placement financing for a leading developer of psychedelic drug therapies signals an important validation of this drug sector's role in mental health treatment, the biotechnology company's CEO told MHW last week.

Increase of Trichoderma harzianum Production Using Mixed-Level Fractional Factorial Design

This research presents the increase of the Trichoderma harzianum production process in a biotechnology company. The NOBA (Near-Orthogonal Balanced arrays) method was used to fractionate a mixed-level factorial design to minimize costs and experimentation times. Our objective is to determine the significant factors to maximize the production process of this fungus. The proposed 213242 mixed-level design involved five factors, including aeration, humidity, temperature, potential hydrogen (pH), and substrate; the response variable was spore production. The results of the statistical analysis showed that the type of substrate, the air supply, and the interaction of these two factors were significant. The maximization of spore production was achieved by using the breadfruit seed substrate and aeration, while it was shown that variations in pH, humidity, and temperature have no significant impact on the production levels of the fungus.

Compliance and regulatory considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory

Multi-attribute methods employing mass spectrometry are applied throughout the biopharmaceutical industry for product and process characterization purposes but are not yet widely accepted as a method for batch release and stability testing under the good manufacturing practice (GMP) regime, due to limited experience and level of comfort with the technical, compliance and regulatory aspects of its implementation at quality control (QC) laboratories. This article is the second part of a two-tiered publication aiming at providing guidance for implementation of the multi-attribute method by peptide mapping liquid chromatography mass spectrometry (MAM) in a QC laboratory. The first part [1] focuses on technical considerations, while this second part provides considerations related to GMP compliance and regulatory aspects. This publication has been prepared by a group of industry experts representing 14 globally acting major biotechnology companies under the umbrella of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing & Quality Expert Group (MQEG).

Microbial Secondary Metabolites via Fermentation Approaches for Dietary Supplementation Formulations.

Food supplementation formulations refer to products that are designed to provide additional nutrients to the diet. Vitamins, dietary fibers, minerals and other functional compounds (such as antioxidants) are concentrated in dietary supplements. Specific amounts of dietary compounds are given to the body through food supplements, and these include as well so-called non-essential compounds such as secondary plant bioactive components or microbial natural products in addition to nutrients in the narrower sense. A significant social challenge represents how to moderately use the natural resources in light of the growing world population. In terms of economic production of (especially natural) bioactive molecules, ways of white biotechnology production with various microorganisms have recently been intensively explored. In the current review other relevant dietary supplements and natural substances (e.g., vitamins, amino acids, antioxidants) used in production of dietary supplements formulations and their microbial natural production via fermentative biotechnological approaches are briefly reviewed. Biotechnology plays a crucial role in optimizing fermentation conditions to maximize the yield and quality of the target compounds. Advantages of microbial production include the ability to use renewable feedstocks, high production yields, and the potential for cost-effective large-scale production. Additionally, it can be more environmentally friendly compared to chemical synthesis, as it reduces the reliance on petrochemicals and minimizes waste generation. Educating consumers about the benefits, safety, and production methods of microbial products in general is crucial. Providing clear and accurate information about the science behind microbial production can help address any concerns or misconceptions consumers may have.

Micro Air Vehicles in India - An Overview

The genesis of the Micro Air Vehicles (MICAV) program and its progress in the last decade is discussed. Fixed, rotary and flapping wing MICAVs (300 mm class) have been successfully flown using remote control by Educational Institutions, Laboratories and enthusiastic entrepreneurs, transmitting video imagery. They are now moving on to autonomous control and its integration with navigation and guidance. The need for micro-sensors has led to work on convergence of micro, nano, bio, info and cogno technologies which are discussed. The need for simulation and cooperative flying of MICAVs with UGVs is stressed and finally the thrust areas for the next five years have been suggested for aerodynamics, structures, control, navigation, guidance, sensors (including bio sensors), power sources, simulation and operations involving brain-machine interface.

The interpretation of [+distal] in demonstratives and complementizers

AbstractThis article argues that the [+distal] feature of demonstrativethatis also present in complementizerthat, and has not bleached away. In particular, we argue that complementizerthatis referential: it refers to an element in theShared Discourse Space(an extension of the Common Ground) that can be seen as distal. This allows us to explain (i) that direct speech patterns with [−distal] (Sue said this/#that: “It is raining”) while indirect speech patterns with [+distal] (Sue said*this/that it is raining); (ii) the use ofthatin exclamatives (That bio industry is still allowed!); and (iii) that optionalthatis more frequently used when there is some sort of context between Speaker and Addressee. This last phenomenon has parallels in Romance complementizers derived from Latinquod, which can likewise be seen as [+distal]. We propose that [+distal] is a marker ofAddressee involvement, which can account for all these phenomena, and can be extended to demonstrative uses ofthat. In exophoric contexts, [+distal] additionally marksactual distance. The interpretation of Addressee involvement and actual distance depends on context; we propose that it is derived from the interaction between the syntactic DP/CP domain and the pragmatic exophoric/endophoric distinction.

‚We are the partner of the global research community‘

When you talk to Marcus Quack, the DACH managing director of Revvity, and ask him what the few-month-old company actually does, he first has to take a deep breath. Previously, the company was still associated with PerkinElmer, whose applied, food and enterprise services were bought for almost 2.5 billion US dollars by the private equity company New Mountain Capital. The new scientific solutions company Revvity, on the other hand, continues to support pharmaceutical and biotech companies as well as diagnostics labs, universities and governments under a new name. ‚Monitor Versorgungsforschung‘ spoke with Marcus Quack about the company‘s rather lofty goals and a possible link to health services research.

The value chain approach in red biotechnology companies from a bibliometric perspective

This paper analyzes the value chain approach in the red biotechnology sector from a bibliometric perspective, using Scopus and Web of Science databases from 2011 to 2021. As a result, 82 documents that cover this topic are analyzed with VOSviewer and R studio. The main findings show that scientific interest increases with a positive publication trend during the considered time period. However, there are no authorship networks in both database. Furthermore, the main reason to use the value chain approach in the red biotech sector is that it highlights the government’s implication on the industry, given its social impact. As a research gap, we recommend to study the effects of Industry 4.0 on the red biotech value chain approach.

New Drugs for Breast Cancer Treatment

Breast cancer is the most common type of cancer in women, affecting approximately 12% of women over the course of their lifetime. It was estimated that there would be 81,550 new cases of invasive breast cancer in women in the United States (US), along with 49,290 new cases of non-invasive breast cancer. A search was conducted to find out the number of new breast cancer drugs that have been approved by US Food and Drug Administration (FDA) in the last 2 years (2020 2021), and the number of breast cancer drugs that are currently under Phase 3 clinical trials. Between 2020 and 2021, 4 new drugs have been approved by FDA for the treatment of breast cancer: Tukysa (Seagen), Margenza (MacroGenics), Phesgo (Genentech), and Trodelvy (Gilead Sciences). Research continues to find out new drugs that can help treat breast cancer. Currently, there are several breast cancer treatment drugs in Phase 3 clinical trials including two major new breast cancer drugs Palbociclib (Pfizer) and Ribociclib (Novartis). Pharmaceutical and biotech companies are making incredible contributions by developing many innovative and effective treatments for breast cancers. We are hopeful that many new breast cancer drugs will be approved in the coming years. Keywords: Breast cancer, Food and Drug Administration(FDA), New Drugs, Clinical Trials.

Robert Ramage. 4 October 1935—16 October 2019

Robert (Bob) Ramage was an innovative and versatile organic chemist who made pioneering contributions to the fields of target-oriented synthesis and synthetic methodology. His research programme was initially focused on the (bio)synthesis of natural products, but later expanded to include peptides and proteins, where he became a key figure in the development of that field in the UK and beyond. As a PhD student in Glasgow, he developed a synthesis of the sesquiterpene cuparene, an achievement that earned him a Fulbright scholarship to Harvard, where he worked under the guidance of R. B. Woodward ForMemRS. With Woodward he participated in the now classic synthesis of the beta-lactam antibiotic cephalosporin C. His independent career began in Liverpool, where he continued his interests in sesquiterpene synthesis, devising several notable syntheses. This period also saw him forge important collaborations with Alan Battersby (FRS 1966) and George Kenner FRS, with whom he worked on the biosynthesis of the alkaloid colchicine and the chemical synthesis of several polypeptides, respectively. In Manchester, and later in Edinburgh, he continued his work in peptide synthesis methodology, a multi-pronged effort that culminated in the successful chemical synthesis of crystalline ubiquitin, widely considered a landmark achievement in the field. His scientific impact reached beyond academia through various consultancies with the pharmaceutical industry and the founding of a successful biotech company. He also assumed various academic leadership roles throughout his career. Bob will be remembered for his exacting standards and resolve to tackle big problems, attributes that he instilled in the many young scientists he mentored. He is dearly missed by all who knew him, by his colleagues around the world and most of all by his family.

A holistic framework for interpreting positive clinical outcomes in biotechnology

Clinical trials conducted by biotechnology companies are vital to not only the success of their products, but the health and safety of future patients. However, positive study results do not always lead to FDA authorization and subsequent release to the market for numerous reasons including, false positive rates, validity and reliability of outcomes, the significance of results, and the semantics of company communications. Driven by the need to compete within the marketplace, biotechnology companies have motivation to distort and/or present results to make them appear more favorable. As a result, it is important to approach positive clinical trial results with a healthy amount of skepticism and utilize a more holistic approach to evaluating results and determining whether the advertised product should be released into the market.

Success factors in drug discovery and development

The article aimed to give a personal perspective on drug discovery and development. The author has worked both in Big Pharma as a scientist and manager and more recently also in start-up biotech companies. Drug companies have played a major important role in improving population health and will continue to do so. The hurdles and costs for drug development have continuously risen without a parallel enhancement of productivity. There is no single explanation for this and the article outlines success factors and hurdles for effective drug development. Aspects of the external and internal environments that influence Big Pharma productivity is outlined and discussed.