Biotech Innovation Research Articles

Frost fighters: unveiling the potential of microbial antifreeze proteins in biotech innovation.

Polar environments pose extreme challenges for life due to low temperatures, limited water, high radiation, and frozen landscapes. Despite these harsh conditions, numerous macro and microorganisms have developed adaptive strategies to reduce the detrimental effects of extreme cold. A primary survival tactic involves avoiding or tolerating intra and extracellular freezing. Many organisms achieve this by maintaining a supercooled state by producing small organic compounds like sugars, glycerol, and amino acids, or through increasing solute concentration. Another approach is the synthesis of ice-binding proteins, specifically antifreeze proteins (AFPs), which hinder ice crystal growth below the melting point. This adaptation is crucial for preventing intracellular ice formation, which could be lethal, and ensuring the presence of liquid water around cells. AFPs have independently evolved in different species, exhibiting distinct thermal hysteresis and ice structuring properties. Beyond their ecological role, AFPs have garnered significant attention in biotechnology for potential applications in the food, agriculture, and pharmaceutical industries. This review aims to offer a thorough insight into the activity and impacts of AFPs on water, examining their significance in cold-adapted organisms, and exploring the diversity of microbial AFPs. Using a meta-analysis from cultivation-based and cultivation-independent data, we evaluate the correlation between AFP-producing microorganisms and cold environments. We also explore small and large-scale biotechnological applications of AFPs, providing a perspective for future research.

A Review on Biotech Innovations in Seed Technology for Robust Crop Production

A Review on Biotech Innovations in Seed Technology for Robust Crop Production

Managing Knowledge for Pharma and Biotech Innovation

Knowledge Management (KM) involves a deliberate and systematic organization of people, processes, structure, and technology with the main objective of creating value for innovation from the reuse of data and information. Although there are several models for KM in various types of organizations, there is nothing concrete to integrate the knowledge generated in collaborative University-Industry projects. This work aimed to gather elements for the creation of a sustainable model of effective articulation in this scenario. It is a strategic action that can bring benefits of intellectual, economic, and social impact. This research used different instruments: systematic mapping, questionnaires, and experience reports. The mapping highlighted the need to consider the following aspects for the development of KM models: collaborative/competitive arrangements, tacit/explicit knowledge managers and change screening. The questionnaire and report demonstrated that the challenges go beyond aspects such as data organization. They must prioritize the social aspect of knowledge sharing, using safe coordination to prevent misconduct.

Fast-to-Clinic, Fast-to-Market in Biotech Innovation: Optimizing Chemistry Manufacturing & Controls (CMC) Excellence for Clinical and Commercial Success

Fast-to-Clinic, Fast-to-Market in Biotech Innovation: Optimizing Chemistry Manufacturing & Controls (CMC) Excellence for Clinical and Commercial Success

The Cost of Biotech Innovation: Exploring Research and Development Costs of Cell and Gene Therapies.

Clinical development paradigms for cell and gene therapies appear to be different to those of more conventional treatments: therefore, it is informative to explore this from the perspective of investments required to bring a new cell and/or gene therapy to the market. While there are a number of studies in the literature analyzing clinical-stage R&D costs for novel therapeutics, these are 'modality-agnostic' and thus do not elucidate costs specifically for the emerging class of cell and gene therapies. The objective of this study was to understand the research and development (R&D) costs associated with the clinical development of new cell and gene therapy assets METHODS: As part of our analysis of clinical-stage R&D costs for cell and gene therapies, we focused our efforts on cell and gene therapy assets recently approved by the US Food and Drug Administration (FDA) or expected to receive FDA approval by the end of 2024. A total of 25 therapies were identified for the study, 11 of which had sufficient level of detail for our clinical-stage R&D costing study. We calculated the clinical-stage R&D costs to bring a new cell and/or gene therapy to the market following a three-step approach, starting with (1) calculation of the out-of-pocket investment reported in US SEC reports; (2) we adjusted these figures for the risk of failure by applying a clinical trial phase-dependent attrition risk rate; (3) we accounted for the cost of capital of 10.5%. After accounting for R&D attrition rate (i.e., costs of failed programs) and applying a cost of capital at 10.5%, we estimate that the clinical-stage R&D investment required to bring a new cell and/or gene therapy to market is US$1943 M (95% CI US$1395 M, US$2490 M). This knowledge can inform financial planning for biopharma companies looking to enter the space and inform policy makers within the context of the commercialization and pricing of such therapies.

Bench-to-bedside: Translational development landscape of biotechnology in healthcare

Biotechnology is a rapidly evolving field that has the potential to transform the way we diagnose and treat diseases and is changing the landscape of healthcare. Great endeavors have been devoted to the field of healthcare biotechnology, and our knowledge of the subject has remarkably improved. By leveraging the latest advancements in molecular biology and genetics, new biotech paradigms are emerging, sparking new searches for novel solutions for human health and well-being. However, the clinical translational development of breakthrough biotechnology discoveries remains an intriguing challenge. Only a few biotech innovations have progressed to new transformative healthcare tools and therapies. In this review, we will outline the clinical translational development landscape of biotechnology in healthcare. Notable discoveries and translational developments in healthcare biotechnology, including classical discoveries and new paradigms, are thoroughly discussed. Even though great challenges remain in the bench-to-bedside translational development process, more groundbreaking biotech ideas are about to be translated into commercial products to bring positive health gains, with a tight multitude of collaboration among research institutes, healthcare providers, and industry partners.

Development of the control system for Artificial Reproduction of Fish Populations Based on a Complex of Neroendocrinological research and Biotech Innovations

The participation of the hypothalamic-hypophysial neurosecretory system (HHNS) in fish reproduction using light, electron microscopy and immunocytochemistry was established by ecologo-histophysiological studies for the first time in the world literature. At the beginning of passing fish migrations a violation of the HHNS basic osmoregulative function, causing habitat change is revealed. Simultaneously the HHNS causes the neurotropic effect on the central nervous system (CNS) arousal in the form of a dominant state of "Migration impulse." At the beginning of spawning, HHNS also initiates spawning behavior and completes it by participating in the body's protective-adaptive reactions to natural physiological stress. The functional role of the HHNS in fish reproduction is to initiate energy-intensive (reproductive) processes of migratory and spawning behaviors and to complete spawning by suppressing the hyperactivity of target glands, which ensures the body's transition to energy-saving plastic exchange. The analysis of the key role of the HHNS in the integration of fish reproduction by the self-regulation principle has allowed the development of a constructive working scheme. New biotech methods of managing breeding time, rates of survival and growth of valuable fish species were developed on this basis. They are presented in the form of 10 inventions. To stimulate sex maturation, drugs of isolated anterior and posterior pituitary lobes were developed and introduced in sturgeon industry, increasing the extent of their fish-breeding use by 15% and saving the pituitary up to 40%. To delay puberty, a method of industrial fish breeders reservation in the critical salinity habitat of 4-8%, both in seawater and in table salt solutions has been developed. On this basis, a full-system method of sturgeon and salmon fish populations reproduction, covering all stages of farm biotechnology has been developed. It is carried out by mass breeders reservation in sea cages, obtaining there offspring and, after the river fish-farm growing youngs to their readiness for migration, the final cultivation them in sea cages gardens till large life-resistant youngs. For the implementation of the proposed industrial biotechnology and year-round fish farming a new installation of recirculating aquaculture systems (RAS) hatcheries and farms was developed by means of the off-season underground conditioning of fish cultivation habitat and by the principle of natural-industrial engineering ecology. Due to the general aim ‒ increasing the efficiency biotechnology of reproduction and logical relationships, all developments are integrated into the system of biotech management of fish population reproduction.

Apple Derived Exosomes Improve Collagen Type I Production and Decrease MMPs during Aging of the Skin through Downregulation of the NF-κB Pathway as Mode of Action.

Skin ageing is strictly related to chronic inflammation of the derma and the decay of structural proteins of the extracellular matrix. Indeed, it has become common practice to refer to this phenomenon as inflammageing. Biotech innovation is always in search of new active principles that induce a youthful appearance. In this paper, apple-derived nanovesicles (ADNVs) were investigated as novel anti-inflammatory compounds, which are able to alter the extracellular matrix production of dermal fibroblasts. Total RNA sequencing analysis revealed that ADNVs negatively influence the activity of Toll-like Receptor 4 (TLR4), and, thus, downregulate the NF-κB pro-inflammatory pathway. ADNVs also reduce extracellular matrix degradation by increasing collagen synthesis (COL3A1, COL1A2, COL8A1 and COL6A1) and downregulating metalloproteinase production (MMP1, MMP8 and MMP9). Topical applications for skin regeneration were evaluated by the association of ADNVs with hyaluronic-acid-based hydrogel and patches.

Exploring the Success of R&D BIOTECH Innovators in Higher Education Institutions: A Case Study of UPLB Agricultural Innovation

This study investigated why and how R&D BIOTECH innovators in higher education institutions achieve success. It used a qualitative method employing a single case study research design. The data was obtained from face-to-face, one-on-one, and open-ended interviews with eight (8) scientists-innovators in UPLB Biotechnology. Descriptive analysis was engaged using coding and content analysis which involved tagging the text to other qualitative data using a system of categories. Based on the results, external Environmental Aspects and External Relations drivers were determined to have unique characteristics related to the R&D BIOTECH agricultural sector influence innovation. Further, findings showed a unique competency pattern and specific attributes that enable successful R&D BIOTECH innovation in higher education institutions. Finally, the knowledge-sharing process significantly contributes to a successful innovation product that the end-users can utilize – farmers and the society at large – bringing social justice.

Research Article: Development of the Control System for Artificial Reproduction of Fish Populations Based on a Complex of Neroendocrinological Research and Biotech Innovations

The participation of the hypothalamic-hypophysial neurosecretory system (HHNS) in fish reproduction using light, electron microscopy and immunocytochemistry was established by ecologo-histophysiological studies for the first time in the world literature. At the beginning of passing fish migrations a violation of the HHNS basic osmoregulative function, causing habitat change is revealed. Simultaneously the HHNS causes the neurotropic effect on the central nervous system (CNS) arousal in the form of a dominant state of "Migration impulse." At the beginning of spawning, HHNS also initiates spawning behavior and completes it by participating in the body's protective-adaptive reactions to natural physiological stress. The functional role of the HHNS in fish reproduction is to initiate energy-intensive (reproductive) processes of migratory and spawning behaviors and to complete spawning by suppressing the hyperactivity of target glands, which ensures the body's transition to energy-saving plastic exchange. The analysis of the key role of the HHNS in the integration of fish reproduction by the self-regulation principle has allowed the development of a constructive working scheme. New biotech methods of managing breeding time, rates of survival and growth of valuable fish species were developed on this basis. They are presented in the form of 10 inventions. To stimulate sex maturation, drugs of isolated anterior and posterior pituitary lobes were developed and introduced in sturgeon industry, increasing the extent of their fish-breeding use by 15% and saving the pituitary up to 40%. To delay puberty, a method of industrial fish breeders reservation in the critical salinity habitat of 4-8‰, both in seawater and in table salt solutions has been developed. On this basis, a full-system method of sturgeon and salmon fish populations reproduction, covering all stages of farm biotechnology has been developed. It is carried out by mass breeders reservation in sea cages, obtaining there offspring and, after the river fish-farm growing youngs to their readiness for migration, the final cultivation them in sea cages gardens till large life-resistant youngs. For the implementation of the proposed industrial biotechnology and year-round fish farming a new installation of recirculating aquaculture systems (RAS) hatcheries and farms was developed by means of the off-season underground conditioning of fish cultivation habitat and by the principle of natural-industrial engineering ecology. Due to the general aim ‒ increasing the efficiency biotechnology of reproduction and logical relationships, all developments are integrated into the system of biotech management of fish population reproduction.

The era of biomarkers and precision medicine in colorectal cancer: an interview with Ajay Goel.

In this interview, Professor Ajay Goel speaks with Storm Johnson, Commissioning Editor for Epigenomics, on his work to date in the field of epigenetic biomarkers in colorectal cancer. Ajay Goel, PhD, is a Professor and Founding Chair of theDepartment of Molecular Diagnostics, at the Beckman Research Institute and Associate Director of Basic Science at the City of Hope comprehensive Cancer Center. Healso serves as Director of Biotech Innovations at the City of Hope, Duarte, CA, USA. DrGoel has spent more than 25 years researching cancer and has been the lead author or contributor to more than 350 scientific articles published in peer-reviewed international journals and several book chapters. He is also a primary inventor on more than 40 international patents aimed at developing various disease biomarkers or therapeutic targets for gastrointestinal cancers. He is currently using advanced genomic, epigenomic and transcriptomic approaches to develop novel circulating, liquid biopsy-based biomarkers (e.g., cell-free nucleic acids, exosomes) for the early detection, prognosis and determination of predictive responses to chemotherapy and targeted drugs in gastrointestinal (GI)cancers. In addition, his group is interested in the identification of novel therapeutic targets, particularly immune therapy, for variousGI cancers. His research also involves understanding the role of gut microbiome, health disparitiesand the prevention of GI cancers using integrative and alternative approaches. DrGoel is a member of the American Association for Cancer Research, American Society of Clinical Oncology and the American Gastroenterology Association. He is on the international editorial boards of several journals, including Gastroenterology, Clinical Cancer Research, Carcinogenesis, PLoS ONE, Molecular Carcinogenesis, Scientific Reports, Epigenomics, Future Oncology, Alternative Therapies in Heath and Medicine, Digestive Diseases and Sciences, and Molecular Therapy Oncolytics. He is also actively involved in peer-reviewing activities for more than 100 international scientific journals and various grant review panels of various national and international funding organizations. His research has been actively funded by various private and federal organizations, including the National Cancer Institute at the NIH, American Cancer Societyand state organizations. He has won more than a dozen national and international awards and honors and has been invited for visiting professorships by various national and international academic institutions and academic bodies.

Europe's Farm to Fork Strategy and Its Commitment to Biotechnology and Organic Farming: Conflicting or Complementary Goals?

The European Commission's Farm to Fork (F2F) strategy, under the European Green Deal, acknowledges that innovative techniques, including biotechnology, may play a role in increasing sustainability. At the same time, organic farming will be promoted, and at least 25% of the EU's agricultural land shall be under organic farming by 2030. How can both biotechnology and organic farming be developed and promoted simultaneously to contribute to achieving the Sustainable Development Goals (SDGs)? We illustrate that achieving the SDGs benefits from the inclusion of recent innovations in biotechnology in organic farming. This requires a change in the law. Otherwise, the planned increase of organic production in the F2F strategy may result in less sustainable, not more sustainable, food systems.

Exploring innovation capabilities build up in the deployment of crop biotechnology innovation in Kenya

ABSTRACT Agro-biotechnology deployment has been very slow in Africa, yet it has potential for enhancing sustainable development and industrialization. This paper attempts to understand the underlying factors that characterize the new technologies’ deployment process. It takes buildup of innovation capabilities as the point of interrogation considering that very few products have received regulatory approval for large-scale commercialization in Africa. It uses Kenya’s agro-biotech innovation system as a case study. The study finds that creating and accumulating innovation capabilities is much broader than research and development (R & D) capability and entails institutional capabilities that are needed to enhance biotech innovation that may lead to a sustainable industrialization.

PUBLIC TRUST AND BIOTECH INNOVATION: A THEORY OF TRUSTWORTHY REGULATION OF (SCARY!) TECHNOLOGY

AbstractRegulatory agencies aim to protect the public by moderating risks associated with innovation, but a good regulatory regime should also promote justified public trust. After introducing the USDA 2020 SECURE Rule for regulation of biotech innovation as a case study, this essay develops a theory of justified public trust in regulation. On the theory advanced here, to be trustworthy, a regulatory regime must (1) fairly and effectively manage risk, must be (2) “science based” in the relevant sense, and must in addition be (3) truthful, (4) transparent, and (5) responsive to public input. Evaluated with these norms, the USDA SECURE Rule is shown to be deeply flawed, since it fails appropriately to manage risk, and similarly fails to satisfy other normative requirements for justified trust. The argument identifies ways in which the SECURE Rule itself might be improved, but more broadly provides a normative framework for the evaluation of trustworthy regulatory policy-making.

OF SOME SPECIFICS IN IMPLEMENTATION OF INTERNATIONAL PRACTICES FOR TECH TRANSFERS OF BIOTECH INNOVATIONS / THE CASE OF THE BULGARIAN UNIVERSITY PLATFORM “VITA PLUS”/

The first-of-its-kind University of Plovdiv transdisciplinary project “Vita Plus” is deemed to adopt some positive international practices to initiate and announce that there are researchers at the University of Plovdiv, interested in realizing tech transfers in the field of biotech innovations. Thus, the goal of the present paper is to explain what factors might be crucial to both characterize technological transfer of biotech innovations as successful from University researchers’ viewpoint, and present them to business ventures for commercial purposes. Research methods of the study include data of the most recent thematic study of the World Bank on Bulgaria and analytical reviews of contemporary scientific literature to establish a modern Bulgarian platform for transfer of biotechnological know-hows to bio-based industries in the forthcoming era of bioeconomy. The results of the research are aimed at formation of comparative-analytical parameters and benchmark indicators for economic valuation of implementation of biotechnological solutions in the emerging Bulgarian circular economy, based on observations at the “Vita Plus” project. Conclusions relate to derivation of a set of recommendations for formation of a new integrated approach for creating a working model for technological transfer of University researches and solutions in real bio-based industrial production through the University platform “Vita Plus”.

The unintended consequences of biotechnology innovation adoption

ABSTRACT We conjecture that adoption of agricultural biotech innovation imposes relationship-specific investments that exacerbate hold-up costs between biotech producers and farmers. Moreover, the increasing presence of biotech reduces biodiversity, which is a significant negative externality on food production across farms. As such, increasing biotech has the potential to exacerbate food insecurity. By contrast, certified organic operations have the potential to have the opposite effect. We examine 15 agrarian states in the U.S. and find evidence strongly consistent with these propositions. We discuss implications for policy, practice, and future research.

Staying ahead of the curve: NICE’s approach to HTA of novel fields of biotech innovation

Staying ahead of the curve: NICE’s approach to HTA of novel fields of biotech innovation

Rethinking the city and innovation: A political economic view from China's biotech

The city is arguably where innovations concentrate. Agglomeration and diversity are two major explanations for why innovations concentrate in the city. Existing studies tend to focus on knowledge dynamics, in particular interfirm networks, while paying insufficient attention to the process of urban development in which knowledge dynamics are materialized. We concur that the city itself does not possess such a power for innovation (Shearmur, 2012). Rather, it is an arena where various actors exert impacts on knowledge dynamics. In a view from China, we reveal why bio-tech innovations concentrate in particular places and what political economic processes contribute to such concentration. We highlight the need for a political economic analysis in economic geographical studies of innovation.

Croda buys marine biology services firm

Croda International has acquired Nautilus Biosciences Canada, a marine biology company based on Prince Edward Island. Croda has partnered with Nautilus, a specialist in marine microbial biodiversity for materials discovery, for six years. The British specialties company intends to establish Nautilus as a marine biotech innovation center. Croda CEO Steve Foots says the deal adds marine biotech to the company’s industrial and plant-based biotechnology.

Where to implement local biotech innovations? A framework for multi-scale socio-economic and environmental impact assessment of Green Bio-Refineries

Green Bio-Refineries (GBRs) have economic and environmental potentials through changing land use from cereals to grass production and provision of grass-based protein feed for livestock production and other valuable byproducts. However, the potentials are dependent on local conditions of the GBRs, such as land productivity, environmental sensitivity and transport distances for feedstock as well as the regional economy which GBRs are a part of. In this paper, we compare the total (direct, indirect and induced) effects of different location choices of GBRs in Denmark at different (municipal, regional, national) scales − a key step for decisions about development of GBRs from both investors' and authorities' perspectives. We integrate a local life-cycle assessment (LCA), a geographic information system (GIS) analysis and an economic-environmental input-output (EEIO) based model (LINE) into a common framework (GIS-LCA-EEIO). We show that locating GBRs in Western Denmark, where the soils are primarily sandy and livestock densities are high, generates higher socio-economic gains than in Eastern Denmark, where the soils are primarily loamy and the concentrations of livestock are lower. We conclude by sketching out priority areas for developing GBRs and discuss the policy implications of the results within the context of development of a bio-based economy.