Without This Enzyme, Insertions Thrive in the Yeast Genome

To protect against such a fate, a suite of DNA-repairing proteins is on standby for when breaks occur. One of them is the evolutionarily conserved enzyme Dna2, which helps prepare broken DNA strands for repair by other proteins and also degrades excess pieces of DNA produced during replication.

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Akari Therapeutics PLC

Akari is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases.

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MedTech

2 Small-Cap Biotech Stocks You Haven't Heard of, But Should Know About

Article | July 12, 2022

With everything that's going on with the COVID-19 pandemic, many healthcare companies have grabbed plenty of spotlight during these challenging times. At the same time, a number of otherwise promising businesses have slipped under the radar. That's especially true for small-cap biotech stocks that aren't actively involved in developing tests, vaccines or treatments for COVID-19. Vaccine developers, protective equipment producers, and healthcare service providers are all attracting plenty of attention during this pandemic, but there are just as many promising biotech stocks that aren't involved in these areas. Here are two such companies that you might have missed, but they deserve a spot on your watch list.

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MedTech

Making Predictions by Digitizing Bioprocessing

Article | October 7, 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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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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MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | October 7, 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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Spotlight

Akari Therapeutics PLC

Akari is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases.

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GP-write Partners with DNA Script to Accelerate DNA-Writing Technology and Accessibility

Genome Project-write | October 18, 2021

GP-write’s CAD is a one-stop shop for microbe, plant and animal genome writing and redesign. Its automated workflow allows users to rapidly upload a genome, redesign it and synthesize the new sequence. The tool enables researchers to directly order synthetic DNA or related products and services from GP-write’s affiliated members. DNA Script’s SYNTAX System, a benchtop DNA printer powered by their groundbreaking enzymatic DNA synthesis (EDS) technology, enables users to print sequences designed on GP-write’s CAD tool right in their lab. The first-of-its-kind DNA printer expedites workflows, making DNA writing as simple and efficient as next-generation sequencing. DNA Script will host a roundtable at the GP-write 5.0 conference on October 22 at 12:30 p.m. ET to engage attendees in a discussion centered on biosecurity as it relates to emerging technologies, including GP-write’s new CAD tool and DNA Script’s SYNTAX System. “We’re pleased to join GP-write and their industrial partners to drive innovation on the forefront of DNA printing technologies. Just as NGS, or DNA 'read,' and CRISPR, or DNA 'edit,' have brought significant advances to research and clinical care, we believe the broad accessibility of synthetic DNA printing, or DNA 'write,' offered by our SYNTAX System will be equally transformative and power the next bio-revolution.” Thomas Ybert, co-founder and CEO of DNA Script GP-write President and General Counsel, Amy Cayne Schwartz, notes that the organizations are partnering to work toward realizing “a shared vision of a future where writing genomes is facile, democratized and safely accessible.” Schwartz explains that “this will open up new frontiers for development of novel therapeutics and solutions for environmental health.” About Genome Project-write GP-write, conceived as a sequel to the Human Genome Project, applies lessons learned from HGP to pursue scientific exploration fully integrated with the development of genome engineering technologies. The primary goal of the project is to drive dramatic cost reductions and expedite whole-genome writing and redesign over the next decade, empowering researchers to uncover complex biological behavior and reprogram organisms to address defining global challenges in medicine, biotechnology and environmental health. About DNA Script Founded in 2014, DNA Script is a pioneering life sciences technology company developing a new, faster, more powerful and versatile way to design and manufacture nucleic acids. The company has developed an alternative to traditional DNA synthesis called Enzymatic DNA Synthesis, or EDS, allowing this technology to be accessible to labs with the first benchtop enzymatic synthesis instrument, the SYNTAX System. By putting DNA synthesis back in the lab, DNA Script aims to transform life sciences research through innovative technology that gives researchers unprecedented control and autonomy.

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New Device Permits a Closer Look at Previously Inaccessible Areas of the Genome

Technology Networks | November 25, 2019

Expansions of DNA repeats are very hard to analyze. A method developed by researchers at the Max Planck Institute for Molecular Genetics in Berlin allows for a detailed look at these previously inaccessible regions of the genome. It combines nanopore sequencing, stem cell, and CRISPR-Cas technologies. The method could improve the diagnosis of various congenital diseases and cancers in the future. Large parts of the genome consist of monotonous regions where short sections of the genome repeat hundreds or thousands of times. But expansions of these "DNA repeats" in the wrong places can have dramatic consequences, like in patients with Fragile X syndrome, one of the most commonly identifiable hereditary causes of cognitive disability in humans. However, these repetitive regions are still regarded as an unknown territory that cannot be examined appropriately, even with modern methods. A research team led by Franz-Josef Müller at the Max Planck Institute for Molecular Genetics in Berlin and the University Hospital of Schleswig-Holstein in Kiel recently shed light on this inaccessible region of the genome. Müller's team was the first to successfully determine the length of genomic tandem repeats in patient-derived stem cell cultures. The researchers additionally obtained data on the epigenetic state of the repeats by scanning individual DNA molecules. The method, which is based on nanopore sequencing and CRISPR-Cas technologies, opens the door for research into repetitive genomic regions, and the rapid and accurate diagnosis of a range of diseases.

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Synthego Launches Genome Engineering for iPS Cells

GEN | October 23, 2019

Synthego’s newest offering applies genome engineering in order to address a longtime challenge in research and drug development—the dearth of high-quality, physiologically relevant biological models needed for translational medicine. The provider of genome engineering products and services this week launched a genome engineering service for induced pluripotent stem (iPS) cells—an expansion of automated cell editing capabilities that according to Synthego is designed to achieve extremely high editing efficiency of iPS cells at an industrial scale. Synthego reasons that iPS cells can provide one of the most reliable and accurate models for disease because they allow researchers to create patient-specific variations. Yet iPS cells created through the reprogramming of human adult cells have traditionally been difficult to handle and modify genetically. Synthego’s new offering of iPS cells includes modification by removal of gene function (knockout), single nucleotide variation, protein tagging and other knock-ins, all with the goal of enabling scientists to generate edits at a massive scale to accelerate research and disease modeling.

Read More

MedTech

GP-write Partners with DNA Script to Accelerate DNA-Writing Technology and Accessibility

Genome Project-write | October 18, 2021

GP-write’s CAD is a one-stop shop for microbe, plant and animal genome writing and redesign. Its automated workflow allows users to rapidly upload a genome, redesign it and synthesize the new sequence. The tool enables researchers to directly order synthetic DNA or related products and services from GP-write’s affiliated members. DNA Script’s SYNTAX System, a benchtop DNA printer powered by their groundbreaking enzymatic DNA synthesis (EDS) technology, enables users to print sequences designed on GP-write’s CAD tool right in their lab. The first-of-its-kind DNA printer expedites workflows, making DNA writing as simple and efficient as next-generation sequencing. DNA Script will host a roundtable at the GP-write 5.0 conference on October 22 at 12:30 p.m. ET to engage attendees in a discussion centered on biosecurity as it relates to emerging technologies, including GP-write’s new CAD tool and DNA Script’s SYNTAX System. “We’re pleased to join GP-write and their industrial partners to drive innovation on the forefront of DNA printing technologies. Just as NGS, or DNA 'read,' and CRISPR, or DNA 'edit,' have brought significant advances to research and clinical care, we believe the broad accessibility of synthetic DNA printing, or DNA 'write,' offered by our SYNTAX System will be equally transformative and power the next bio-revolution.” Thomas Ybert, co-founder and CEO of DNA Script GP-write President and General Counsel, Amy Cayne Schwartz, notes that the organizations are partnering to work toward realizing “a shared vision of a future where writing genomes is facile, democratized and safely accessible.” Schwartz explains that “this will open up new frontiers for development of novel therapeutics and solutions for environmental health.” About Genome Project-write GP-write, conceived as a sequel to the Human Genome Project, applies lessons learned from HGP to pursue scientific exploration fully integrated with the development of genome engineering technologies. The primary goal of the project is to drive dramatic cost reductions and expedite whole-genome writing and redesign over the next decade, empowering researchers to uncover complex biological behavior and reprogram organisms to address defining global challenges in medicine, biotechnology and environmental health. About DNA Script Founded in 2014, DNA Script is a pioneering life sciences technology company developing a new, faster, more powerful and versatile way to design and manufacture nucleic acids. The company has developed an alternative to traditional DNA synthesis called Enzymatic DNA Synthesis, or EDS, allowing this technology to be accessible to labs with the first benchtop enzymatic synthesis instrument, the SYNTAX System. By putting DNA synthesis back in the lab, DNA Script aims to transform life sciences research through innovative technology that gives researchers unprecedented control and autonomy.

Read More

New Device Permits a Closer Look at Previously Inaccessible Areas of the Genome

Technology Networks | November 25, 2019

Expansions of DNA repeats are very hard to analyze. A method developed by researchers at the Max Planck Institute for Molecular Genetics in Berlin allows for a detailed look at these previously inaccessible regions of the genome. It combines nanopore sequencing, stem cell, and CRISPR-Cas technologies. The method could improve the diagnosis of various congenital diseases and cancers in the future. Large parts of the genome consist of monotonous regions where short sections of the genome repeat hundreds or thousands of times. But expansions of these "DNA repeats" in the wrong places can have dramatic consequences, like in patients with Fragile X syndrome, one of the most commonly identifiable hereditary causes of cognitive disability in humans. However, these repetitive regions are still regarded as an unknown territory that cannot be examined appropriately, even with modern methods. A research team led by Franz-Josef Müller at the Max Planck Institute for Molecular Genetics in Berlin and the University Hospital of Schleswig-Holstein in Kiel recently shed light on this inaccessible region of the genome. Müller's team was the first to successfully determine the length of genomic tandem repeats in patient-derived stem cell cultures. The researchers additionally obtained data on the epigenetic state of the repeats by scanning individual DNA molecules. The method, which is based on nanopore sequencing and CRISPR-Cas technologies, opens the door for research into repetitive genomic regions, and the rapid and accurate diagnosis of a range of diseases.

Read More

Synthego Launches Genome Engineering for iPS Cells

GEN | October 23, 2019

Synthego’s newest offering applies genome engineering in order to address a longtime challenge in research and drug development—the dearth of high-quality, physiologically relevant biological models needed for translational medicine. The provider of genome engineering products and services this week launched a genome engineering service for induced pluripotent stem (iPS) cells—an expansion of automated cell editing capabilities that according to Synthego is designed to achieve extremely high editing efficiency of iPS cells at an industrial scale. Synthego reasons that iPS cells can provide one of the most reliable and accurate models for disease because they allow researchers to create patient-specific variations. Yet iPS cells created through the reprogramming of human adult cells have traditionally been difficult to handle and modify genetically. Synthego’s new offering of iPS cells includes modification by removal of gene function (knockout), single nucleotide variation, protein tagging and other knock-ins, all with the goal of enabling scientists to generate edits at a massive scale to accelerate research and disease modeling.

Read More

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