How synthetic biology will transform manufacturing and improve sustainability

Sustainability is in vogue, with businesses and cities jostling to improve their public image and produce goods and services using renewable sources. Yet cities exponentially swell and carbon emissions continue to increase. Global CO2 emissions rise nearly every year (about 36 billion tons in 2014), with the bulk of these derived from solid and liquid fuels.

Spotlight

Yumanity Therapeutics

Yumanity Therapeutics is transforming drug discovery for neurodegenerative diseases caused by protein misfolding. Despite the fact that an estimated 50 million people worldwide suffer from diseases affecting the brain and central nervous system, there are no approved disease-modifying therapies or cures. Yumanity is working to identify and develop new, disease-modifying therapies that address several illnesses with critical unmet medical needs, including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). The company’s approach concentrates on correcting the cellular pathologies driven by misfolded proteins, the altered biology or phenotypes driving these diseases.

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MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | July 13, 2022

Introduction The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials. For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care. Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS. Key Steps for Selecting Right Biotech Clinical Trial Management System Prioritize Study Needs Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices. Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task. Select CTMS with Multiple Integrations Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection. Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes. Ensure System Compliance and Security Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties. While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project. Assess the Scalability Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility. As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure. The Closing Thought A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.

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MedTech

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | July 12, 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

Biotech in 2022

Article | July 20, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

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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

Yumanity Therapeutics

Yumanity Therapeutics is transforming drug discovery for neurodegenerative diseases caused by protein misfolding. Despite the fact that an estimated 50 million people worldwide suffer from diseases affecting the brain and central nervous system, there are no approved disease-modifying therapies or cures. Yumanity is working to identify and develop new, disease-modifying therapies that address several illnesses with critical unmet medical needs, including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). The company’s approach concentrates on correcting the cellular pathologies driven by misfolded proteins, the altered biology or phenotypes driving these diseases.

Related News

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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