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Exploring the Fourth Dimension of Proteome Analysis

Just a few years ago, it was a successful feat for a proteomics researcher to identify the proteins, peptides and post-translation modifications in a single or small number of samples. Fast-forward ten years, and the field has changed dramatically. Now, scientists want to conduct analyses on a larger scale, with sample numbers extending beyond the hundreds into the thousands. This analysis must be of a high-quality, with high-sensitivity and specificity, yet efficient – particularly when considering the applications of proteomics in the personalized medicine and biomarker detection spaces.

Spotlight

BioFlorida, Inc

BioFlorida is the voice of Florida’s life sciences industry, representing nearly 6,000 establishments and research organizations in the biopharmaceutical, medical technology and bioagriculture sectors that collectively employ nearly 83,000 Floridians (Source: The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life, TEConomy/BIO, 2016).

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MedTech

Better Purification and Recovery in Bioprocessing

Article | July 13, 2022

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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MedTech

2022 U.S. Market Research Report with COVID-19 Forecasts2

Article | October 7, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

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MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | July 12, 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

Immunology: A New Frontier in Medical Science

Article | July 16, 2022

Introduction Recent developments in the bioengineering of monoclonal antibodies (mAbs) have revolutionized the treatment of numerous rheumatic and immunological disorders. Currently, several immunological disorders are successfully being targeted and treated using innovative medical techniques such as immunotherapy. Leading companies are increasingly investing in research activities to expand the usage and application of immunology for the treatment of various infectious diseases, including multiple sclerosis, inflammatory bowel disorders, lupus, and psoriasis, leading companies are increasingly investing in research activities. Today, the efforts of researchers in immunology, with a long history of study and research, have borne fruit, as bioengineered mAbs are now being employed in clinical practices. Accelerating Investments: Paving the Way for Immunology The increasing prevalence of infectious diseases, cancer, and immune-mediated inflammatory disorders (IMIDs) is raising the need for more precise classification and an in-depth understanding of the pathology underlying these ailments. Numerous leaders in the biotechnology domain are thus focusing on undertaking numerous strategies, such as new facility launches and collaborations, to address the need by finding deeper inroads into immunology and its use in disease treatments. For instance, in 2022, the University of Texas MD Anderson Cancer Center announced the launch of a visionary research and innovation hub, the James P. Allison Institute, to find new roads in immunotherapy, develop new treatments, and foster groundbreaking science. These developments will result in better diagnosis through the use of selective biomarkers, and early detection of fatal diseases and their treatment, which will prevent complications from happening. Also, the identification of high-risk populations through a deeper understanding of genetic and environmental factors can assist in the prevention of disease through immunotherapy. The Way Forward Immunology has led to the development of biotechnology, making it possible to develop novel drugs and vaccines, as well as diagnostic tests, that can be used to prevent, diagnose, and treat a wide range of autoimmune, infectious, and cancerous diseases. With the rapid advancement in technology and the integration of artificial intelligence, immunology is finding its way into an array of domains and industries, encompassing several research areas including medicine, pharmaceuticals, agriculture, and space. Today, not only researchers but also leading biotech and pharmaceutical companies have recognized that conventional therapies with pharmaceutical and chemical products are being replaced by products derived from immunology. This is because they work well for health problems, are environmentally friendly, and are also emerging as a wealth-generating business in the medical field.

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MedTech

Next-Gen Gene Therapy to Counter Complex Diseases

Article | July 13, 2022

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

Read More
MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | October 7, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

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MedTech

Expansion of BioPharma: Opportunities and Investments

Article | July 12, 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.

Read More
MedTech

Immunology: A New Frontier in Medical Science

Article | July 16, 2022

Introduction Recent developments in the bioengineering of monoclonal antibodies (mAbs) have revolutionized the treatment of numerous rheumatic and immunological disorders. Currently, several immunological disorders are successfully being targeted and treated using innovative medical techniques such as immunotherapy. Leading companies are increasingly investing in research activities to expand the usage and application of immunology for the treatment of various infectious diseases, including multiple sclerosis, inflammatory bowel disorders, lupus, and psoriasis, leading companies are increasingly investing in research activities. Today, the efforts of researchers in immunology, with a long history of study and research, have borne fruit, as bioengineered mAbs are now being employed in clinical practices. Accelerating Investments: Paving the Way for Immunology The increasing prevalence of infectious diseases, cancer, and immune-mediated inflammatory disorders (IMIDs) is raising the need for more precise classification and an in-depth understanding of the pathology underlying these ailments. Numerous leaders in the biotechnology domain are thus focusing on undertaking numerous strategies, such as new facility launches and collaborations, to address the need by finding deeper inroads into immunology and its use in disease treatments. For instance, in 2022, the University of Texas MD Anderson Cancer Center announced the launch of a visionary research and innovation hub, the James P. Allison Institute, to find new roads in immunotherapy, develop new treatments, and foster groundbreaking science. These developments will result in better diagnosis through the use of selective biomarkers, and early detection of fatal diseases and their treatment, which will prevent complications from happening. Also, the identification of high-risk populations through a deeper understanding of genetic and environmental factors can assist in the prevention of disease through immunotherapy. The Way Forward Immunology has led to the development of biotechnology, making it possible to develop novel drugs and vaccines, as well as diagnostic tests, that can be used to prevent, diagnose, and treat a wide range of autoimmune, infectious, and cancerous diseases. With the rapid advancement in technology and the integration of artificial intelligence, immunology is finding its way into an array of domains and industries, encompassing several research areas including medicine, pharmaceuticals, agriculture, and space. Today, not only researchers but also leading biotech and pharmaceutical companies have recognized that conventional therapies with pharmaceutical and chemical products are being replaced by products derived from immunology. This is because they work well for health problems, are environmentally friendly, and are also emerging as a wealth-generating business in the medical field.

Read More
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Spotlight

BioFlorida, Inc

BioFlorida is the voice of Florida’s life sciences industry, representing nearly 6,000 establishments and research organizations in the biopharmaceutical, medical technology and bioagriculture sectors that collectively employ nearly 83,000 Floridians (Source: The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life, TEConomy/BIO, 2016).

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Flagship Pioneering Announces the Merger of Two Leading Programmable Medicine Platforms to Form Sail Biomedicines

PR Newswire | October 25, 2023

Flagship Pioneeringannounced the combination of Laronde and Senda Biosciences to launch Sail Biomedicines, a company pioneering the design and deployment of fully programmable medicines to transform patient care. Sail harnesses the power of first-in-category programmable payloads of Endless RNA™ (eRNA), first-in-category programmable nanoparticles, and emerging, proprietary AI technologies, to unlock the comprehensive programming of medicines for the first time. Guillaume Pfefer, Ph.D., MBA, who is also CEO-Partner at Flagship Pioneering, will become Sail's CEO and board member, while John Mendlein, Ph.D., who also serves as Executive Partner, Flagship Pioneering, will become the company's Executive Chairman. Sail unites Laronde and Senda Biosciences, two companies that deliver more than eight years of combined data and multi-product platform building. Senda's platform was the first to leverage a universal chemical code of natural nanoparticles that enables directed and repeatable deployment of payloads, such as translatable RNA, directly to cells and tissues of choice. Laronde pioneered eRNA, a new class of synthetic, translatable RNA that can be programmed to express diverse proteins inside the body, with vast therapeutic potential. "Endless RNA has the potential to create an entirely new class of programmable medicines across therapeutic areas that we will now be able to deliver directly to cells and tissues via deployment molecules with unique properties to confer specificity and greater tolerability," said Mendlein. "We believe these programmable medicines will be greatly enhanced via our proprietary generative AI technologies and rapid prototyping abilities to achieve breakthroughs currently beyond the grasp of the human mind. I look forward to working with the Sail Biomedicines team in this exciting new chapter." "Our deployment platform utilizes natural nanoparticles to shuttle biomolecules into human cells, with unique tropism, potency, and redosability," said Pfefer. "I look forward to leading the integration of these two teams to accelerate the development of new product candidates, build strategic partnerships, and enable diverse value pools, with the goal of swiftly delivering life-changing vaccines and therapies for the people who need them." "Sail Biomedicines builds on the progress made by two leading Flagship bioplatform companies and will enable integrative design for more effective programmable medicines," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering. "I am confident the combined leadership team and board will carry forward this company to realize its bold ambitions and ultimately deliver maximum impact for patients." In addition to Mendlein and Pfeffer, the Sail Biomedicines Board of Directors will comprise all current members of the Laronde and Senda Biosciences boards, as follows Pablo Cagnoni, M.D., President and Head of Research & Development, Incyte Jose "Pepe" Carmona, MBA, Chief Financial Officer, ADC Therapeutics Paula Hammond, Ph.D., Institute Professor, Massachusetts Institute of Technology, Head of Department of Chemical Engineering, Massachusetts Institute of Technology Avak Kahvejian, Ph.D., General Partner, Flagship Pioneering Ignacio Martinez, MBA, General Partner, Flagship Pioneering Sheri McCoy, M.S., MBA, Former Vice Chairman, Johnson & Johnson Mary Szela, MBA, CEO and President, TriSalus Life Sciences About Sail Biomedicines Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail's platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of generative AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering. About Flagship Pioneering Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. To date, Flagship has deployed over $3.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $26 billion of follow-on investments from other institutions.

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Medical

Integrated DNA Technologies Opens New Therapeutic Manufacturing Facility to Support Growing Demand in Genomic Medicine

businesswire | October 19, 2023

Global genomics solutions provider Integrated DNA Technologies (IDT), an operating company in the Life Sciences segment of Danaher Corporation announced the completion of its new Therapeutic Oligonucleotide Manufacturing facility in Coralville, Iowa. The milestone marks a significant achievement in the company’s 35-year-history—its entrance into the therapeutics space—and enables IDT to manufacture products for research use through to current good manufacturing practice (cGMP) grade cell and gene therapy reagents to provide researchers with a single partner that can help them rapidly transition from the lab to therapeutic development. The 41,000-square-foot-site will produce cGMP cell and gene therapy reagents, including single guide RNAs (sgRNAs) and donor oligos for homology-directed repair (HDR) with additional offerings to follow. These new capabilities and offerings will be supported with comprehensive documentation and testing, a support team, and regulatory guidance to help accelerate researchers’ path to the clinic. “An increasing number of customers are seeking out IDT as a trusted partner for their CRISPR genome editing needs, and are asking us to be the provider that can help them bridge the gap from lab to clinic,” said Demaris Mills, president, IDT. “Now, with our new cGMP manufacturing facility, IDT can provide a complete CRISPR workflow—from design to analysis—that supports cell and gene therapy developers in all stages of therapeutic development, with the same support and expertise they have come to know from IDT. These new manufacturing capabilities, which have been informed by our decades of oligonucleotide synthesis manufacturing expertise, evolves IDT’s business model from Research Use Only to cGMP, and enables us to help more people.” Danaher Vice President and Group Executive Chris Riley added, “The future of genomic medicine hinges on the industrialization of biology to make life-saving therapies more accessible to people. As a pioneer in genome editing, IDT’s continued investments will enable customers to rapidly move from clinical development to commercialization. This new facility is another significant milestone in IDT’s innovation journey, one we envision will have a profound impact in genomic medicine for years to come.” The Therapeutic Oligo Manufacturing facility features ISO 8 cleanrooms, purification suites, chemical distribution and storage rooms, quality control labs, analytical lab space for product testing, ancillary and office spaces and shell space for future expansion. Manufacturing is performed in accordance with ICH Q7 cGMP standards for consistent and reliable quality. The controlled-access building features environmental controls for temperature, humidity and air pressure throughout, supported by an environmental program and continuous monitoring system. The addition of this new facility expands IDT’s global manufacturing footprint and enables the company to provide a range of manufacturing capabilities, including Research Use Only (RUO), large scale RUO, Engineering Run and cGMP (ICH Q7). A Decade of CRISPR Innovation Since 2015, IDT has continued to accelerate the pace of genomics with its complete portfolio of Alt-R™ CRISPR genome editing solutions. Its portfolio includes several first-to-market research products as well as solutions to meet researchers’ complete workflow—from design to analysis—to enable greater quality, simplicity, and cost efficiency. Last year, IDT launched the Alt-R™ HDR Donor Blocks, an improved solution for increasing homology-directed repair (HDR) rates in large fragment knock-in experiments, and expanded access to its Alt-R™ Custom CRISPR gRNA Libraries for drug discovery. In 2021, IDT also unveiled its rhAmpSeq™ CRISPR Analysis System, an end-to-end solution for characterizing and quantifying the full array of on- and off-target genome editing events in CRISPR research products. IDT’s research and development teams have also been at the forefront of CRISPR innovation, with achievements that include the development of multiple proprietary CRISPR reagents such as IDT’s Alt-R™ S.p. HiFi Cas9 Nuclease and the Alt-R L.b. and A.s. Cas12a (Cpf1) Ultra enzymes. Notably, their groundbreaking research and collaborations with scientists around the globe has been published in more than 200 scientific journals as peer-reviewed articles, and is helping to shape the future of genomics and biotechnology. IDT collaborated with M.A. Mortenson Company, a team led by OPN Architects and Barr Engineering Co. on the facility design and construction of its cGMP facility. About IDT For more than 35 years, Integrated DNA Technologies, Inc. (IDT) has been empowering genomics laboratories with an oligonucleotide manufacturing process unlike anyone else in the industry, with the most advanced synthesis, modification, purification, and quality control capabilities available. Since its founding in 1987, IDT has progressed from a leading oligo manufacturer to a genomics solutions provider supporting key application areas such as next generation sequencing, CRISPR genome editing, synthetic biology, digital PCR, and RNA interference. IDT manufactures products used by scientists researching many forms of cancer and most inherited and infectious diseases.

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Medical

Zenfold Leverages Ginkgo Enzyme Services to Enable Veterinary Active Ingredient Development with Sustainable Biology

PR Newswire | October 17, 2023

Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, and Zenfold Sustainable Technologies, a company focused on developing and manufacturing specialty ingredients using sustainable technologies and precision fermentation, today announced a collaboration to leverage Ginkgo Enzyme Services in its effort to discover an enzyme critical to the manufacturing of veterinary products. This partnership aims to replace traditional chemical processes in veterinary active ingredient production with a sustainable biological method. "This collaboration marks a significant step forward in Zenfold's mission to bring sustainable manufacturing technology to the veterinary medicine industry," said Dr. BSV Prasad, CEO and Managing Director of Zenfold Sustainable Technologies. "By utilizing Ginkgo's expertise and innovation, we are well-positioned to develop a sustainable solution that will have a lasting impact on the Indian market and beyond." "We are excited to partner with Zenfold, which brings a powerful vision of sustainable biotechnology to veterinary active ingredient development. This collaboration will enable us to apply our state-of-the-art enzyme discovery module to enable more innovation in the veterinary medicine space," said Jennifer Wipf, SVP, Head of Commercial, Cell Engineering at Ginkgo. "The project involves creating a broad library of cDNA candidates from a metagenomic collection of billions of enzyme sequences. That's the kind of scale visionary projects like this need, and Ginkgo is committed to scaling up this solution for the betterment of animal health and the environment." About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. About Zenfold Zenfold Sustainable Technologies is a pioneer in the field of sustainable biology, with a focus on veterinary actives and enzyme supply. This collaboration with Ginkgo Bioworks marks Zenfold's expansion into the global veterinary market and further emphasizes their commitment to environmental responsibility and innovative biological solutions.

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Medical

Flagship Pioneering Announces the Merger of Two Leading Programmable Medicine Platforms to Form Sail Biomedicines

PR Newswire | October 25, 2023

Flagship Pioneeringannounced the combination of Laronde and Senda Biosciences to launch Sail Biomedicines, a company pioneering the design and deployment of fully programmable medicines to transform patient care. Sail harnesses the power of first-in-category programmable payloads of Endless RNA™ (eRNA), first-in-category programmable nanoparticles, and emerging, proprietary AI technologies, to unlock the comprehensive programming of medicines for the first time. Guillaume Pfefer, Ph.D., MBA, who is also CEO-Partner at Flagship Pioneering, will become Sail's CEO and board member, while John Mendlein, Ph.D., who also serves as Executive Partner, Flagship Pioneering, will become the company's Executive Chairman. Sail unites Laronde and Senda Biosciences, two companies that deliver more than eight years of combined data and multi-product platform building. Senda's platform was the first to leverage a universal chemical code of natural nanoparticles that enables directed and repeatable deployment of payloads, such as translatable RNA, directly to cells and tissues of choice. Laronde pioneered eRNA, a new class of synthetic, translatable RNA that can be programmed to express diverse proteins inside the body, with vast therapeutic potential. "Endless RNA has the potential to create an entirely new class of programmable medicines across therapeutic areas that we will now be able to deliver directly to cells and tissues via deployment molecules with unique properties to confer specificity and greater tolerability," said Mendlein. "We believe these programmable medicines will be greatly enhanced via our proprietary generative AI technologies and rapid prototyping abilities to achieve breakthroughs currently beyond the grasp of the human mind. I look forward to working with the Sail Biomedicines team in this exciting new chapter." "Our deployment platform utilizes natural nanoparticles to shuttle biomolecules into human cells, with unique tropism, potency, and redosability," said Pfefer. "I look forward to leading the integration of these two teams to accelerate the development of new product candidates, build strategic partnerships, and enable diverse value pools, with the goal of swiftly delivering life-changing vaccines and therapies for the people who need them." "Sail Biomedicines builds on the progress made by two leading Flagship bioplatform companies and will enable integrative design for more effective programmable medicines," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering. "I am confident the combined leadership team and board will carry forward this company to realize its bold ambitions and ultimately deliver maximum impact for patients." In addition to Mendlein and Pfeffer, the Sail Biomedicines Board of Directors will comprise all current members of the Laronde and Senda Biosciences boards, as follows Pablo Cagnoni, M.D., President and Head of Research & Development, Incyte Jose "Pepe" Carmona, MBA, Chief Financial Officer, ADC Therapeutics Paula Hammond, Ph.D., Institute Professor, Massachusetts Institute of Technology, Head of Department of Chemical Engineering, Massachusetts Institute of Technology Avak Kahvejian, Ph.D., General Partner, Flagship Pioneering Ignacio Martinez, MBA, General Partner, Flagship Pioneering Sheri McCoy, M.S., MBA, Former Vice Chairman, Johnson & Johnson Mary Szela, MBA, CEO and President, TriSalus Life Sciences About Sail Biomedicines Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail's platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of generative AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering. About Flagship Pioneering Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. To date, Flagship has deployed over $3.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $26 billion of follow-on investments from other institutions.

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Medical

Integrated DNA Technologies Opens New Therapeutic Manufacturing Facility to Support Growing Demand in Genomic Medicine

businesswire | October 19, 2023

Global genomics solutions provider Integrated DNA Technologies (IDT), an operating company in the Life Sciences segment of Danaher Corporation announced the completion of its new Therapeutic Oligonucleotide Manufacturing facility in Coralville, Iowa. The milestone marks a significant achievement in the company’s 35-year-history—its entrance into the therapeutics space—and enables IDT to manufacture products for research use through to current good manufacturing practice (cGMP) grade cell and gene therapy reagents to provide researchers with a single partner that can help them rapidly transition from the lab to therapeutic development. The 41,000-square-foot-site will produce cGMP cell and gene therapy reagents, including single guide RNAs (sgRNAs) and donor oligos for homology-directed repair (HDR) with additional offerings to follow. These new capabilities and offerings will be supported with comprehensive documentation and testing, a support team, and regulatory guidance to help accelerate researchers’ path to the clinic. “An increasing number of customers are seeking out IDT as a trusted partner for their CRISPR genome editing needs, and are asking us to be the provider that can help them bridge the gap from lab to clinic,” said Demaris Mills, president, IDT. “Now, with our new cGMP manufacturing facility, IDT can provide a complete CRISPR workflow—from design to analysis—that supports cell and gene therapy developers in all stages of therapeutic development, with the same support and expertise they have come to know from IDT. These new manufacturing capabilities, which have been informed by our decades of oligonucleotide synthesis manufacturing expertise, evolves IDT’s business model from Research Use Only to cGMP, and enables us to help more people.” Danaher Vice President and Group Executive Chris Riley added, “The future of genomic medicine hinges on the industrialization of biology to make life-saving therapies more accessible to people. As a pioneer in genome editing, IDT’s continued investments will enable customers to rapidly move from clinical development to commercialization. This new facility is another significant milestone in IDT’s innovation journey, one we envision will have a profound impact in genomic medicine for years to come.” The Therapeutic Oligo Manufacturing facility features ISO 8 cleanrooms, purification suites, chemical distribution and storage rooms, quality control labs, analytical lab space for product testing, ancillary and office spaces and shell space for future expansion. Manufacturing is performed in accordance with ICH Q7 cGMP standards for consistent and reliable quality. The controlled-access building features environmental controls for temperature, humidity and air pressure throughout, supported by an environmental program and continuous monitoring system. The addition of this new facility expands IDT’s global manufacturing footprint and enables the company to provide a range of manufacturing capabilities, including Research Use Only (RUO), large scale RUO, Engineering Run and cGMP (ICH Q7). A Decade of CRISPR Innovation Since 2015, IDT has continued to accelerate the pace of genomics with its complete portfolio of Alt-R™ CRISPR genome editing solutions. Its portfolio includes several first-to-market research products as well as solutions to meet researchers’ complete workflow—from design to analysis—to enable greater quality, simplicity, and cost efficiency. Last year, IDT launched the Alt-R™ HDR Donor Blocks, an improved solution for increasing homology-directed repair (HDR) rates in large fragment knock-in experiments, and expanded access to its Alt-R™ Custom CRISPR gRNA Libraries for drug discovery. In 2021, IDT also unveiled its rhAmpSeq™ CRISPR Analysis System, an end-to-end solution for characterizing and quantifying the full array of on- and off-target genome editing events in CRISPR research products. IDT’s research and development teams have also been at the forefront of CRISPR innovation, with achievements that include the development of multiple proprietary CRISPR reagents such as IDT’s Alt-R™ S.p. HiFi Cas9 Nuclease and the Alt-R L.b. and A.s. Cas12a (Cpf1) Ultra enzymes. Notably, their groundbreaking research and collaborations with scientists around the globe has been published in more than 200 scientific journals as peer-reviewed articles, and is helping to shape the future of genomics and biotechnology. IDT collaborated with M.A. Mortenson Company, a team led by OPN Architects and Barr Engineering Co. on the facility design and construction of its cGMP facility. About IDT For more than 35 years, Integrated DNA Technologies, Inc. (IDT) has been empowering genomics laboratories with an oligonucleotide manufacturing process unlike anyone else in the industry, with the most advanced synthesis, modification, purification, and quality control capabilities available. Since its founding in 1987, IDT has progressed from a leading oligo manufacturer to a genomics solutions provider supporting key application areas such as next generation sequencing, CRISPR genome editing, synthetic biology, digital PCR, and RNA interference. IDT manufactures products used by scientists researching many forms of cancer and most inherited and infectious diseases.

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Zenfold Leverages Ginkgo Enzyme Services to Enable Veterinary Active Ingredient Development with Sustainable Biology

PR Newswire | October 17, 2023

Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, and Zenfold Sustainable Technologies, a company focused on developing and manufacturing specialty ingredients using sustainable technologies and precision fermentation, today announced a collaboration to leverage Ginkgo Enzyme Services in its effort to discover an enzyme critical to the manufacturing of veterinary products. This partnership aims to replace traditional chemical processes in veterinary active ingredient production with a sustainable biological method. "This collaboration marks a significant step forward in Zenfold's mission to bring sustainable manufacturing technology to the veterinary medicine industry," said Dr. BSV Prasad, CEO and Managing Director of Zenfold Sustainable Technologies. "By utilizing Ginkgo's expertise and innovation, we are well-positioned to develop a sustainable solution that will have a lasting impact on the Indian market and beyond." "We are excited to partner with Zenfold, which brings a powerful vision of sustainable biotechnology to veterinary active ingredient development. This collaboration will enable us to apply our state-of-the-art enzyme discovery module to enable more innovation in the veterinary medicine space," said Jennifer Wipf, SVP, Head of Commercial, Cell Engineering at Ginkgo. "The project involves creating a broad library of cDNA candidates from a metagenomic collection of billions of enzyme sequences. That's the kind of scale visionary projects like this need, and Ginkgo is committed to scaling up this solution for the betterment of animal health and the environment." About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. About Zenfold Zenfold Sustainable Technologies is a pioneer in the field of sustainable biology, with a focus on veterinary actives and enzyme supply. This collaboration with Ginkgo Bioworks marks Zenfold's expansion into the global veterinary market and further emphasizes their commitment to environmental responsibility and innovative biological solutions.

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