Scientists Find Fuel Production Potential in Cyanobacteria

The researchers used cyanobacteria, a peculiar class of microorganisms, for producing butanol. Systematic use of these bacteria helped produce continually increasing quantities of butanol. The use of high-breed cyanobacteria helps produce larger quantities of butanol than what scientists generally perceive. The researchers said the quantity of production rises when they fed the bacteria with sugar.

Spotlight

IBBR Institute for Bioscience and Biotechnology Research

IBBR is a University System of Maryland joint research enterprise among the University of Maryland College Park, the University of Maryland Baltimore, and the National Institute of Standards and Technology. With a long-standing scientific focus on structure-function relationships of biomolecules, genetic systems, and applications, e.g., vaccines, therapeutics, drug delivery technologies, and biomanufacturing, IBBR’s mission is to leverage its unique capabilities and infrastructure to marshal innovative technologies and expertise across its partnering institutions, to foster integrated, cross-disciplinary team approaches to scientific research and education, and to pursue translational programs and projects aimed at advancing innovations to commercialization in real world applications. The Institute also serves to expand the economic base of science and technology in the state of Maryland and at the national level.

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MedTech

Making Predictions by Digitizing Bioprocessing

Article | July 11, 2022

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech. “Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says. Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects. “The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.” To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

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Medical

5 Biotech Stocks Winning the Coronavirus Race

Article | August 16, 2022

There are quite a few companies that have found ways to grow their business during the ongoing COVID-19 pandemic. This is especially true for a number of biotechs now working on developing a potential treatment for, or vaccine against, the virus; shares of such companies have largely surged over the past couple of months. Although many of these treatments and vaccines are still have quite a way to go before they're widely available, it's still worth taking some time to look through what's going on in the COVID-19 space right now. Here are five biotech stocks that are leading the way when it comes to addressing COVID-19. Regeneron Pharmaceuticals (NASDAQ:REGN) wasn't among the initial wave of companies to announce a potential COVID-19 drug. However, investor excitement quickly sent shares surging when the company announced that its rheumatoid arthritis drug, Kevzara, could help treat COVID-19 patients.

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MedTech

Wisconsin biotech companies could play key roles in long-term economic recovery from COVID-19 pandemic

Article | September 22, 2022

Whether it’s called a modern “Manhattan Project” or a medical moon shot, the concept of long-term economic recovery rests on how confident people are they won’t risk serious illness by venturing forth in public again. Wisconsin stands to be a significant part of such an undertaking, whatever it’s called. The shorter-term debate is well under way over the gradual lifting of COVID-19 emergency rules, such as the now-extended “safer-at-home” order in Wisconsin. At least a dozen states, including regional coalitions on the East and West coasts, are exploring next steps as they seek to balance responses to the virus with calls for reopening the economy, at least, in part. Wisconsin’s ability to shape longer-term responses will come from private and public resources, which range from companies engaged in production of diagnostics.

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MedTech

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | September 22, 2022

Introduction The administration of medical records and data has advanced significantly during the past few decades. Clinical data management, which was once only a small subset of biotech research organizations, has now developed into a mission-critical, specialized unit. In the late 1990s, electronic data capture (EDC) began to alter the traditional function of clinical data management. After that, the data configuration and management of data queries for the EDC system fell under the purview of clinical data management services. Today, clinical data management is not only responsible for managing the clinical data configuration and data queries but also developing and implementing data administration plans, ensuring data accuracy and completeness, and maintaining optimum data security. In recent years, as digital technologies have gained acceptance around the globe, data has become a vital aspect in decision-making across numerous industries, and the life sciences and biotechnology sectors are no exception. Using data has provided granular insights to biotech organizations, assisting them in creating breakthroughs in drug development and medical research and signifying the importance of clinical trial management systems in these medical verticals. The Biggest Biotech Clinical Data Management Trends to Know About Today The future of clinical data management is contingent upon the implementation of systems and regulations. It is imperative for all organizations participating in a medical or life science trial to have transparent rules in place for sharing and retaining patient data. Also, there is a need to have a standardized format for maintaining these records and documents related to trials. This assists biotech organizations in reducing the chances of ambiguity regarding who owns what kind of data or paperwork at any given time. Over the past couple of years, the focus of the life science and biotechnology industries has shifted towards developing more effective medications and therapies, implementing personalized treatment, and finding cures for diseases such as cancer and AIDS. In response to this, a substantial rise in the number of clinical trials is being witnessed globally. As the number of clinical trials continues to accelerate, the spending on these trials rises as well. In response to this, the worldwide cost of conducting clinical trials is anticipated to reach US$ 49.80 billion in 2022. With the transition of the world from traditional to digital, medical professionals and biotech businesses are increasingly shifting towards adopting high-tech and reliable clinical trial management systems for various applications, starting from diagnosis and clinical trials to patient data documentation. But, what are the future trends in biotechnology clinical data management? Let’s discuss. Cloud-Based Clinical Metadata Repositories Automation is emerging as a new frontier in the biotech clinical data management domain, along with other innovative technologies such as artificial intelligence and machine learning. Because of this, life science establishments are witnessing a huge shift from paper-based documentation toward data-based documentation, which is creating mountains of research, compliance, and clinical data. The growing demand for new and more effective medications and drugs is augmenting the need to expedite clinical trials. This is resulting in an increased number of initiatives aimed at optimizing clinical trial processes to prepare and launch successful trials. However, pharmaceutical and biotechnology laboratories are encountering several challenges in collecting, managing, and analyzing metadata due to its complexities. So, what is the best solution to this problem? The answer to this is cloud-based clinical metadata repositories. Clinical research facilities are leveraging advanced, all-in-one, cloud-based clinical metadata repositories to assist them in centralizing and managing metadata; increasing metadata quality, consistency, and accuracy; and speeding up clinical trial management, documentation, and compliance processes. Shift Towards Digital Solutions Electronic Case Report Form Adequate research and accurate data are crucial for a clinical trial to succeed. Whether developing new drugs, medication, or therapies; conducting life science research; or studying the latest clinical trial systems, it is best to use electronic solutions as it reduces the room for mistakes during the transition of clinical data from paper-based format. Realizing this, biotech organizations are shifting towards using electronic case report forms to speed up record retrieval, improve record security, and cut down on operational costs associated with running clinical trials. The electronic case report form assists in lowering the failure rate of the clinical trial, enhancing efficiency, and optimizing security along with improving clinical trial documentation and productivity, further driving its adoption in the medical space. Electronic Clinical Outcome Assessment Electronic clinical outcome assessment is surfacing as one of the fast-growing future trends in biotechnology. It allows clinical trial facilities to automate data entry and improve the reliability of the collected information. The technology enables clinical trial institutions to automatically record patient-provided information about side effects, symptoms, drug timing, and other aspects during the clinical trial for increased precision. It also helps these institutions analyze the results of medication or therapy in clinical trials and lets clinical researchers use medical technologies like biosensor-enabled devices, self-service applications, and medical wearables for evaluation. Hence, biotech clinical facilities are increasingly deploying advanced electronic clinical outcome assessment systems to ensure adherence to protocols and regulations. Clinical Trial Customization The success of a new drug is determined by numerous factors other than its effectiveness, safety, and creativity of its developers, such as a successful clinical trial. Each clinical trial involves a number of decision-making points, and one wrong choice in any of these aspects can jeopardize the success of the entire endeavor. A crucial component of making well-informed decisions is data management, which is a part of clinical study as a whole. Clinical trial customization is emerging as one of the most prominent biotech clinical trial management trends. Every clinical trial is unique and needs a tailored approach to be successful. With the emergence of the trend of personalized treatment around the globe, biotech and pharmaceutical organizations are adopting innovative customized clinical trial management solutions to accelerate the pace of clinical trials and approvals. This is giving clinical researchers innovative ways to come up with new medicines for patients and streamline the clinical data as per the requirements for faster approvals. What Are the Key Clinical Data Management Challenges Faced by Biotech Companies? Groundbreaking medical interventions are of no use without reliable, accurate, and extensive clinical trial data. Without the data, biotech and pharmaceutical companies will not be able to provide the assurance of safety and efficacy required to bring the medication to market. Regulatory bodies such as the Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and others are putting stricter rules in place to ensure the quality of clinical data. In addition, the fast-changing clinical development environment is creating more obstacles for biotech and medical spaces to ensure the accuracy, standard, and completeness of the clinical trial data. Hence, clinical teams are spending valuable time cleaning up data instead of analyzing it. Time spent trying to figure out issues with clinical trial data is detrimental and expensive but also mission-critical. This is because a small issue in the data can lead to numerous consequences, from small delays to calamitous setbacks, making it necessary to rerun clinical trials. This problem will only get more challenging to address as the volume of data and the types of data sources continue to grow. Here are some of the major clinical data management challenges that biotech firms encounter Standardization of Clinical Metadata Stringent Regulatory Compliance Increased Clinical Trial Complexity Mid-Study Changes Why Are Clinical Data Management Systems Garnering Popularity in the Biotech Industry? With the changing regulatory and clinical landscape, biotech and pharmaceutical companies are facing several obstacles in the management of clinical data and clinical trials. In addition, regulatory agencies are moving toward integrated electronic systems, which is making it more and more important for clinical laboratories to change the format of their submissions. Because of this, several biotech clinical labs are focusing on adopting innovative laboratory solutions, such as biotech clinical data management systems, to meet the need for standardized data inputs and replace all manual ways of working with electronic systems. A clinical data management system establishes the framework for error-free data collection and high-quality data submission, resulting in speedier drug discovery and shorter time-to-market. These solutions are gaining huge traction among biotech and pharmaceutical companies, owing to their ability to effectively manage clinical data, accelerate clinical trials, and ensure compliance. Let’s see some of the features of biotech clinical data management software that are most sought after by life-science companies Controlled, standardized data repository. Centralized data analysis and administration. Reduced operational expenditures for clinical data processes. Enhanced process effectiveness. Superior submission quality Compliance with predefined standards. Clinical Data Management Systems: The Future The role of clinical data management systems is evolving at a rapid pace as the life science and medical industries continue to incorporate digital solutions for diverse operations. These systems are being used in a variety of biotech clinical settings, ranging from clinical data compliance to data science and analytics, to help them analyze large and growing volumes of clinical data. Hence, a number of high-tech medical companies are aiming at integrating innovative technologies, such as artificial intelligence and machine learning, into clinical data management software to automate clinical data management tasks, improve clinical data submission, and enhance data quality. These new biotech clinical management technologies are anticipated to help life science laboratories gain a better understanding of diseases and speed up clinical trials in the coming years. FAQ What is a clinical data management system? A clinical data management system (CDMS) is a tool used in clinical research to track, record, and manage clinical trial data across medical establishments such as biotech laboratories. What are the key functions of the biotech clinical data management system? Some of the key functions of biotech clinical data management system are Documentation of Protocols and Regulations Patient Recruitment Real-time Clinical Study Analytics Reporting Investigator Relationship Management Electronic Visit Report Why is a clinical data management system needed for clinical trials today? A clinical data management system helps shorten the time from drug development to marketing by assisting in the collection of high-quality, statistically sound, and accurate data from clinical trials.

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Spotlight

IBBR Institute for Bioscience and Biotechnology Research

IBBR is a University System of Maryland joint research enterprise among the University of Maryland College Park, the University of Maryland Baltimore, and the National Institute of Standards and Technology. With a long-standing scientific focus on structure-function relationships of biomolecules, genetic systems, and applications, e.g., vaccines, therapeutics, drug delivery technologies, and biomanufacturing, IBBR’s mission is to leverage its unique capabilities and infrastructure to marshal innovative technologies and expertise across its partnering institutions, to foster integrated, cross-disciplinary team approaches to scientific research and education, and to pursue translational programs and projects aimed at advancing innovations to commercialization in real world applications. The Institute also serves to expand the economic base of science and technology in the state of Maryland and at the national level.

Related News

Novel peptide could lead to antibiotic for drug-resistant bacteria

Drug Target Review | November 22, 2019

An international team of researchers has discovered a novel peptide that attacks gram negative bacteria at a previously unknown site of action. Germs such as Escherichia coli and Klebsiella pneumoniae have become resistant to the most – and in some cases all – currently available antibiotics. Their additional external membrane makes these difficult to attack as it protects the bacteria by preventing many substances from getting into the cell interior. Especially for the treatment of diseases caused by these so-called gram negative bacteria, there is a lack of new active substances. “Since the 1960s, scientists have not succeeded in developing a new class of antibiotics effective against gram negative bacteria, but this could now be possible with the help of this peptide,” said Professor Till Schäberle from the Institute of Insect Biotechnology at Justus Liebig University Giessen (JLU) and project leader at the DZIF, whose research group was involved in the discovery.

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Gut Bacteria May Impact Aging

Technology Networks | November 19, 2019

An international research team led by Nanyang Technological University, Singapore (NTU Singapore) has found that microorganisms living in the gut may alter the ageing process, which could lead to the development of food-based treatment to slow it down. All living organisms, including human beings, coexist with a myriad of microbial species living in and on them, and research conducted over the last 20 years has established their important role in nutrition, physiology, metabolism and behaviour. Using mice, the team led by Professor Sven Pettersson from the NTU Lee Kong Chian School of Medicine, transplanted gut microbes from old mice (24 months old) into young, germ-free mice (6 weeks old). After eight weeks, the young mice had increased intestinal growth and production of neurons in the brain, known as neurogenesis. The team showed that the increased neurogenesis was due to an enrichment of gut microbes that produce a specific short chain fatty acid, called butyrate. Butyrate is produced through microbial fermentation of dietary fibres in the lower intestinal tract and stimulates production of a pro-longevity hormone called FGF21, which plays an important role in regulating the body’s energy and metabolism. As we age, butyrate production is reduced.

Read More

Having a Certain Type of Bacteria in Your Guts May Increase Risk of Developing Bowel Cancer

Technology Networks | November 04, 2019

In the first study to use a technique called Mendelian randomization to investigate the causal role played by bacteria in the development of bowel cancer, Dr Kaitlin Wade, from the University of Bristol, told the 2019 NCRI Cancer Conference: “We found evidence that the presence of an unclassified type of bacteria from a bacterial group called Bacteroidales increased the risk of bowel cancer by between 2-15%. “This means that, on average, people with this type of bacteria within their gut may have a slightly higher risk of bowel cancer compared to those who don’t. We were able to use Mendelian randomization to understand the causal role that these bacteria may have on the disease. Our findings support previous studies that have shown that Bacteroidales bacteria are more likely to be present, and in larger quantities, in individuals with bowel cancer compared to those without the disease.” The microbiome is a community of microorganisms, bacteria in this case, that occur naturally in the body. There is increasing evidence that the make-up of the microbiome plays a role in the human health and the body’s susceptibility to disease. The human gut microbiome, which contains approximately three trillion bacteria, aids digestion and provides protection against infections. It is determined by a person’s individual genetic makeup and their environment, so is unique to each person. It also remains relatively stable across a person’s life, unless it is affected by antibiotics, an illness or a change of diet, among other things.

Read More

Novel peptide could lead to antibiotic for drug-resistant bacteria

Drug Target Review | November 22, 2019

An international team of researchers has discovered a novel peptide that attacks gram negative bacteria at a previously unknown site of action. Germs such as Escherichia coli and Klebsiella pneumoniae have become resistant to the most – and in some cases all – currently available antibiotics. Their additional external membrane makes these difficult to attack as it protects the bacteria by preventing many substances from getting into the cell interior. Especially for the treatment of diseases caused by these so-called gram negative bacteria, there is a lack of new active substances. “Since the 1960s, scientists have not succeeded in developing a new class of antibiotics effective against gram negative bacteria, but this could now be possible with the help of this peptide,” said Professor Till Schäberle from the Institute of Insect Biotechnology at Justus Liebig University Giessen (JLU) and project leader at the DZIF, whose research group was involved in the discovery.

Read More

Gut Bacteria May Impact Aging

Technology Networks | November 19, 2019

An international research team led by Nanyang Technological University, Singapore (NTU Singapore) has found that microorganisms living in the gut may alter the ageing process, which could lead to the development of food-based treatment to slow it down. All living organisms, including human beings, coexist with a myriad of microbial species living in and on them, and research conducted over the last 20 years has established their important role in nutrition, physiology, metabolism and behaviour. Using mice, the team led by Professor Sven Pettersson from the NTU Lee Kong Chian School of Medicine, transplanted gut microbes from old mice (24 months old) into young, germ-free mice (6 weeks old). After eight weeks, the young mice had increased intestinal growth and production of neurons in the brain, known as neurogenesis. The team showed that the increased neurogenesis was due to an enrichment of gut microbes that produce a specific short chain fatty acid, called butyrate. Butyrate is produced through microbial fermentation of dietary fibres in the lower intestinal tract and stimulates production of a pro-longevity hormone called FGF21, which plays an important role in regulating the body’s energy and metabolism. As we age, butyrate production is reduced.

Read More

Having a Certain Type of Bacteria in Your Guts May Increase Risk of Developing Bowel Cancer

Technology Networks | November 04, 2019

In the first study to use a technique called Mendelian randomization to investigate the causal role played by bacteria in the development of bowel cancer, Dr Kaitlin Wade, from the University of Bristol, told the 2019 NCRI Cancer Conference: “We found evidence that the presence of an unclassified type of bacteria from a bacterial group called Bacteroidales increased the risk of bowel cancer by between 2-15%. “This means that, on average, people with this type of bacteria within their gut may have a slightly higher risk of bowel cancer compared to those who don’t. We were able to use Mendelian randomization to understand the causal role that these bacteria may have on the disease. Our findings support previous studies that have shown that Bacteroidales bacteria are more likely to be present, and in larger quantities, in individuals with bowel cancer compared to those without the disease.” The microbiome is a community of microorganisms, bacteria in this case, that occur naturally in the body. There is increasing evidence that the make-up of the microbiome plays a role in the human health and the body’s susceptibility to disease. The human gut microbiome, which contains approximately three trillion bacteria, aids digestion and provides protection against infections. It is determined by a person’s individual genetic makeup and their environment, so is unique to each person. It also remains relatively stable across a person’s life, unless it is affected by antibiotics, an illness or a change of diet, among other things.

Read More

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