Optimization of cell-free biosensors for synthetic biology

Cell-free synthetic biology recently became a branch of synthetic biology with dedicated research groups and conferences. Cell-free systems present a great potential for synthetic biology, allowing for quick in vitro transcription-translation from circular or linear DNA. The most common cell-free systems nowadays are lysate-based cell-free systems which are made by combining cell extract plus reaction buffers. These systems were initially used for fundamental discoveries in molecular biology (study of the genetic code and translation process) and later on to produce recombinant protein. In the past few years, cell-free attracted synthetic biologists’ attention as a platform for high-throughput characterization and prototyping of natural and synthetic biological circuitry. As advantages of cell-free systems we can be list: Non-GMO hosts, absence of growth dependent challenges, lower level of noise, less susceptibility to toxicity, simple cloning as genes can be cloned separately or possibility of using linear DNA (PCR product), high adjustability by varying the concentration of DNA parts or buffer elements.

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Watchmaker Genomics

Watchmaker Genomics combines deep domain expertise in protein engineering with enzyme manufacturing to address the demanding quality, performance and scale requirements of high-growth genomics applications. We see our clients as partners and view technical and supply chain challenges as opportunities for mutual success. Watchmaker’s best-in-class scientific competencies enable a disruptive approach to life science partnerships.

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Medical

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | August 16, 2022

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

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MedTech

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | July 12, 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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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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Medical

Nanostructures: Emerging as Effective Carriers for Drug Delivery

Article | July 14, 2022

Natural remedies have been employed in medicine since antiquity. However, a large number of them fail to go past the clinical trial stages. In vivo instability, poor solubility and bioavailability, a lack of target-specific delivery, poor absorption, and side effects of the medication are only a few of the problems caused by the use of large-sized materials in drug administration. Therefore, adopting novel drug delivery systems with targeted medications may be a solution to address these pressing problems. Nanotechnology has received tremendous attention in recent years and has been demonstrated to help blur the boundaries between the biological and physical sciences. With great success, it plays a vital part in enhanced medication formulations, targeted venues, and controlled drug release and delivery. Limitations of Traditional Delivery Trigger the Adoption of Nanoparticles The field of nanotechnology and the creation of drug formulations based on nanoparticles is one that is expanding and showcasing great potential. It has been thoroughly researched in an effort to develop new methods of diagnosis and treatment and to overcome the limitations of several diseases' current therapies. As a result, nanoparticles are being used to improve the therapeutic effectiveness and boost patient adherence to treatment by increasing medication bioavailability, drug accumulation at a particular spot, and reducing drug adverse effects. The nanoparticles could be transformed into intelligent systems housing therapeutic and imaging agents by manipulating their surface properties, size, correct drug load, and release with targeted drug delivery. Nanostructures facilitate the release of combination medications at the prescribed dose since they remain in the blood circulation system for a long time. Therefore, they result in fewer plasma fluctuations with decreased side effects. Due to their nanoscale, these structures can easily enter the tissue system, promote the absorption of drugs by cells, make medication administration more effective, and ensure that the medicine acts at the targeted location. The Way Ahead Nanomedicine and nano-delivery systems are a comparatively new but fast-evolving science in which nanoscale materials are used as diagnostic tools to deliver drug molecules at precisely targeted sites in a controlled manner. It is finding applications for the treatment of diseases such as cardiovascular, neurodegenerative, cancer, ocular, AIDS, and diabetes, among others. With more research and technological advancement, these drug delivery solutions will open up huge opportunities for companies that work with them.

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Spotlight

Watchmaker Genomics

Watchmaker Genomics combines deep domain expertise in protein engineering with enzyme manufacturing to address the demanding quality, performance and scale requirements of high-growth genomics applications. We see our clients as partners and view technical and supply chain challenges as opportunities for mutual success. Watchmaker’s best-in-class scientific competencies enable a disruptive approach to life science partnerships.

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AI

eureKARE and DNAlytics Form Partnership to Develop a Proprietary AI Platform

eureKARE | July 07, 2021

eureKARE, a pioneering new company focused on financing and building next-generation biotechnology companies in the disruptive fields of the microbiome and synthetic biology, today announced an agreement with DNAlytics, a Belgian company applying data sciences to healthcare, to develop eureKARE's proprietary Artificial Intelligence (AI) platform to support its Biotech start-upstart-up studios, eureKARE. Unlike conventional start-upstart-up incubation methods, which begin with new science and then attempt to find an issue to address with it, eureKARE's methodology reverses this. eureKARE is committed to first finding an unmet need and then enlisting the best scientists and experts to provide an innovative solution to launch exciting new ventures. This process will be aided by eureKARE's one-of-a-kind AI platform, which will assist the business in identifying top academic researchers, locating new ideas and approaches in development, and scaling existing portfolio companies. About eureKARE eureKARE is a ground-breaking new company focusing on financing and establishing next-generation biotechnology start-ups in the microbiome and synthetic biology cutting-edge areas. eureKARE employs a two-step investing strategy to create long-term value. Through its biotech start-upstart-up studios eureKABIOME (Microbiome) and eureKASYNBIO, the company promotes translational research by developing and financing new companies based on high-value European science (Synthetic biology). In addition, the company aims to engage in more mature biotech companies. It will systematically propose to provide some liquidity to early investors, thus fulfilling a crucial demand in the European biotech sector. EureKARE has a fast-expanding portfolio of companies with the potential to disrupt the life sciences sector, led by its prominent founder, Alexandre Mouradian, and a pan-European team. About DNAlytics DNAlytics is based in Louvain-la-Neuve, Belgium, specializing in data science for the healthcare sector, including data management, bioinformatics, biostatistics, Machine Learning, and other Artificial Intelligence methods. DNAlytics products are utilized in clinical research, the creation of biotech drugs and medical devices, public health studies, and the monitoring and optimization of bio-manufacturing processes. In addition, DNAlytics assists a wide range of clients and partners in extracting scientifically sound observations and practical conclusions from complex data sets.

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Tennessee researchers join call for responsible development of synthetic biology

Phys.org | October 18, 2019

Engineering biology is already transforming technology and science, and a consortium of researchers across many disciplines in the international Genome Project-write is calling for more discussion among scientists, policy makers and the general public to shepherd future development. In a policy forum article published in the October 18 issue of Science, the authors outline the technological advances needed to secure the transformative future of synthetic biology and express their concerns that the implementation of the relatively new discipline remains safe and responsible. Two researchers with the University of Tennessee Institute of Agriculture are co-authors on the piece titled "Technological challenges and milestones for writing genomes: synthetic genomics requires improved technologies." Neal Stewart and Scott Lenaghan with the UTIA departments of Plant Sciences and Food Science, respectively, join Nili Ostrov, a Ph.D. research fellow in genetics at Harvard Medical School, and 18 other leading scientists from a number of institutions and disciplines, in outlining a potential timeline for the development of what they call transformative advances to science and society.

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Bioactive Agents Improve Synthetic Bone Substitutes

Technology Networks | October 18, 2019

Synthetic bone substitutes are promising materials for bone defect repair, but their efficacy can be substantially improved by bioactive agents such as growth factors. In a new study, researchers have modified beta-tricalcium phosphate (β-TCP) with increasing quantities of bone morphogenetic protein 2 (BMP-2) derived from E. coli and shown improved bone healing. The study is published in Tissue Engineering, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. Yuelian Liu, PhD, Academic Center for Dentistry Amsterdam, Amsterdam, Netherlands, and colleagues present their work in an article titled "Dose Effects of Slow-Released Bone Morphogenetic Protein-2 Functionalized β-Tricalcium Phosphate in Repairing Critical-Sized Bone Defects". The authors created bone defects in a rat calvarial model and then attempted repair using β-TCP granules coated with a biomimetic calcium phosphate preparation that allows slow release of BMP-2. Bone growth and maturation were studied in comparison with autologous bone grafts using micro-CT scans, histology, and histomorphometry, and toxicity was assessed with blood tests. The E. coli-derived BMP-2 successfully improved bone formation with efficacy comparable to autologous grafts, and higher BMP-2 concentration promoted bone maturation.

Read More

AI

eureKARE and DNAlytics Form Partnership to Develop a Proprietary AI Platform

eureKARE | July 07, 2021

eureKARE, a pioneering new company focused on financing and building next-generation biotechnology companies in the disruptive fields of the microbiome and synthetic biology, today announced an agreement with DNAlytics, a Belgian company applying data sciences to healthcare, to develop eureKARE's proprietary Artificial Intelligence (AI) platform to support its Biotech start-upstart-up studios, eureKARE. Unlike conventional start-upstart-up incubation methods, which begin with new science and then attempt to find an issue to address with it, eureKARE's methodology reverses this. eureKARE is committed to first finding an unmet need and then enlisting the best scientists and experts to provide an innovative solution to launch exciting new ventures. This process will be aided by eureKARE's one-of-a-kind AI platform, which will assist the business in identifying top academic researchers, locating new ideas and approaches in development, and scaling existing portfolio companies. About eureKARE eureKARE is a ground-breaking new company focusing on financing and establishing next-generation biotechnology start-ups in the microbiome and synthetic biology cutting-edge areas. eureKARE employs a two-step investing strategy to create long-term value. Through its biotech start-upstart-up studios eureKABIOME (Microbiome) and eureKASYNBIO, the company promotes translational research by developing and financing new companies based on high-value European science (Synthetic biology). In addition, the company aims to engage in more mature biotech companies. It will systematically propose to provide some liquidity to early investors, thus fulfilling a crucial demand in the European biotech sector. EureKARE has a fast-expanding portfolio of companies with the potential to disrupt the life sciences sector, led by its prominent founder, Alexandre Mouradian, and a pan-European team. About DNAlytics DNAlytics is based in Louvain-la-Neuve, Belgium, specializing in data science for the healthcare sector, including data management, bioinformatics, biostatistics, Machine Learning, and other Artificial Intelligence methods. DNAlytics products are utilized in clinical research, the creation of biotech drugs and medical devices, public health studies, and the monitoring and optimization of bio-manufacturing processes. In addition, DNAlytics assists a wide range of clients and partners in extracting scientifically sound observations and practical conclusions from complex data sets.

Read More

Tennessee researchers join call for responsible development of synthetic biology

Phys.org | October 18, 2019

Engineering biology is already transforming technology and science, and a consortium of researchers across many disciplines in the international Genome Project-write is calling for more discussion among scientists, policy makers and the general public to shepherd future development. In a policy forum article published in the October 18 issue of Science, the authors outline the technological advances needed to secure the transformative future of synthetic biology and express their concerns that the implementation of the relatively new discipline remains safe and responsible. Two researchers with the University of Tennessee Institute of Agriculture are co-authors on the piece titled "Technological challenges and milestones for writing genomes: synthetic genomics requires improved technologies." Neal Stewart and Scott Lenaghan with the UTIA departments of Plant Sciences and Food Science, respectively, join Nili Ostrov, a Ph.D. research fellow in genetics at Harvard Medical School, and 18 other leading scientists from a number of institutions and disciplines, in outlining a potential timeline for the development of what they call transformative advances to science and society.

Read More

Bioactive Agents Improve Synthetic Bone Substitutes

Technology Networks | October 18, 2019

Synthetic bone substitutes are promising materials for bone defect repair, but their efficacy can be substantially improved by bioactive agents such as growth factors. In a new study, researchers have modified beta-tricalcium phosphate (β-TCP) with increasing quantities of bone morphogenetic protein 2 (BMP-2) derived from E. coli and shown improved bone healing. The study is published in Tissue Engineering, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. Yuelian Liu, PhD, Academic Center for Dentistry Amsterdam, Amsterdam, Netherlands, and colleagues present their work in an article titled "Dose Effects of Slow-Released Bone Morphogenetic Protein-2 Functionalized β-Tricalcium Phosphate in Repairing Critical-Sized Bone Defects". The authors created bone defects in a rat calvarial model and then attempted repair using β-TCP granules coated with a biomimetic calcium phosphate preparation that allows slow release of BMP-2. Bone growth and maturation were studied in comparison with autologous bone grafts using micro-CT scans, histology, and histomorphometry, and toxicity was assessed with blood tests. The E. coli-derived BMP-2 successfully improved bone formation with efficacy comparable to autologous grafts, and higher BMP-2 concentration promoted bone maturation.

Read More

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