Building Bioprocessing from Data

First and foremost, by developing your bioprocess with a focus on collecting and analyzing all of the data attendant to that process, you can go back and audit what you’ve done in a high resolution manner. You should also realize that the data is going to include some very subtle and nuanced things. In manufacturing a cell product, for instance, you’re going to want to dive deep into the starting material analytics—everything from genomics to transcriptomics and secretomics, etc. If you generate this huge dataset and then analyze it, you’ll be able to figure out what subtle differences between, for example, the starting material genome or the starting material transcriptome actually impacts and influences what you get in the end product.

Spotlight

Anthos Therapeutics

Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for people living with cardiovascular and metabolic (CVM) diseases.

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Research

Immunology: A New Frontier in Medical Science

Article | July 11, 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

Laboratory Information Management System for Biotech Labs: Significance & Benefits

Article | July 13, 2022

If you have ever visited the testing laboratory of a large biotechnology company, you will be aware that managing the laboratory's operations single-handedly is no easy task. The greater the size of a lab, the more research and testing activities it must accommodate. A variety of diagnostic tests are prescribed for patients in order to detect various diseases. For example, it may include blood glucose testing for diabetics, lipid panel, or liver panel tests for evaluating cardiac risk and liver function, cultures for diagnosing infections, thyroid function tests, and others. Laboratory management solutions such as laboratory information management systems (LIMS) and other software play a significant role in managing various operational data at biotech laboratories. It is one of the important types of software developed to address thedata management and regulatory challenges of laboratories. The software enhances the operational efficiency of biotech labs by streamlining workflows, proper record-keeping, and eradicating the need for manually maintaining data. What Are the Benefits of Laboratory Information Management Software in Biotechnology? As the trends of digitization and technology continue to create deeper inroads into the biotechnology sector, a significant rise in the adoption of innovative medical software solutions, such as LIMS, is being witnessed for managing research data, testing reports, and post-research results globally. Here are a few reasons that are encouraging biotech facilities to adopt LIMS solutions Real-Time Data Collection and Tracking Previously, collecting and transporting samples was a tedious and time-consuming task. However, the adoption of LIMS with innovative tracking modules has made the job easier. The real-time sample tracking feature of LIMS has made it possible for personnel to collect the research data in real-time and manage and control the workflow with a few mouse clicks on the screen. Increase Revenue LIMS makes it possible to test workflows while giving users complete control over the testing process. A laboratory is able to collect data, schedule equipment maintenance or upgrades, enhance operational efficiency, and maintain a lower overhead with the help of the LIMS, thereby increasing revenue. Streamlined Workflow With its completion monitoring, LIMS speeds up laboratory workflows and keeps track of information. It assigns tasks to the specialist along with keeping a real-time track of the status and completion of each task. LIMS is integrated into the laboratory using lab information, which ultimately speeds up internal processes and streamlines the workflow. Automatic Data Exchange LIMS solutions store data in a centralized database. Automated transfer of data between departments and organizations is one of the major features of LIMS. Through its automated information exchange feature, LIMS improves internal operations, decreases the reporting time for data sharing, and assists in faster decision-making. Final Thoughts As the healthcare sector continues to ride the wave of digital transformation, biotech laboratories are emphasizing adopting newer technologies to keep up with the changes. Citing this trend, laboratory information management systems are becoming crucial for biotech and medical organizations for maintaining research data, instant reporting, and managing confidential, inventory, and financial data with centralized data storage.

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MedTech

Nanostructures: Emerging as Effective Carriers for Drug Delivery

Article | July 20, 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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MedTech

Next-Gen Gene Therapy to Counter Complex Diseases

Article | July 13, 2022

Gene therapy has historically been used to treat disorders with in-depth knowledge caused by a single genetic mutation. Thanks to the introduction of new generation technologies, the potential of gene therapy is expanding tAo treat diseases that were previously untreatable. Evolution of Gene Therapy One of the major success stories of the twenty-first century has been gene therapy. However, it has not been the same in the past. The field's journey to this point has been long and mostly difficult, with both tragedy and triumph along the way. Initially, genetic disorders were thought to be untreatable and permanently carved into the genomes of individuals unfortunate enough to be born with them. But due to the constant technological advancement and research activities, gene therapy now has the potential to treat various genetic mutation-causing diseases with its ability to insert a new copy and replace faulty genes. Gene Therapy is Finding New Roads in the Medical Sector Gene therapy can help researchers treat a variety of conditions that fall under the general heading of epilepsy, instead of only focusing on a particular kind of disorder brought on by a genetic mutation. Following are some of the domains transformed by gene therapy. Neurology – Gene therapy can be used for the treatment of seizures by directly injecting it into the area causing an uncontrolled electrical disturbance in the brain. Furthermore, by using DNA sequences known as promoters, gene therapy can be restricted to specific neurons within that area. Ophthalmology – Genetic conditions such as blindness can be caused due to the mutation of any gene out of over 200 and resulting in progressive vision loss in children. With advanced gene therapies such as optogenetics, lost photoreceptor function can be transferred to the retinal cells, which are responsible for relaying visual information to the brain. This might give patients the ability to navigate in an unknown environment with a certain level of autonomy. The Future of Gene Therapy The news surrounding gene therapy has been largely favorable over the past few years, with treatment after treatment obtaining regulatory approvals, successful clinical trials, and garnering significant funds to begin development. With more than 1,000 clinical trials presently underway, the long-awaited gene therapy revolution might finally be here.

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Spotlight

Anthos Therapeutics

Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for people living with cardiovascular and metabolic (CVM) diseases.

Related News

Advances in Cell Culture Media Formulation and Development

Genengnews | July 10, 2019

For decades commercial and academic scientists have sought reliable serum-free media. As far back as the 1960s a number of options were available for the cultivation of some cell lines. Now, after years of effort, many of the shortcomings of these early formulations have been resolved, and researchers have a number of highly successful alternatives available. For CHO bioproduction in a fed-batch process, there are two media and feed systems that we recommend. The first, the EX-CELL. Advanced CHO Fed Batch System, is optimized for fed-batch processes. The second, Cellvento. 4CHO medium and 4Feed, are unique in that the feed contains a modified form of tyrosine, which allows high concentrations of this amino acid at neutral pH. Both systems contain only chemically defined components and are animal- component free. These two media systems display high titers, protein quality, and scalability when operating in a fed-batch mode. However, if the bioproduction process is perfusion, then the nutritional needs of the cell line will be different and a medium optimized for that mode of production is essential.

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Cobra Biologics and Symbiosis Complete Viral Vector Collaboration

Genengnews | July 10, 2019

Cobra Biologics, a CDMO focused on viral vector drug substance production, and Symbiosis Pharmaceutical Services, a CMO specializing in the sterile manufacture of injectable viral vector drug products, reported the successful completion of their collaboration to develop synergistic capabilities. Intended to accelerate the clinical and commercial production of viral vectors, which represent part of the burgeoning Advanced Therapeutics Medicinal Product (ATMP) drug development space and the growth of personalized medicine, the 18-month joint project saw a combined investment of £4.8m including significant support from a grant received under the U.K. government’s Innovate UK Health and Life Sciences Program. The collaboration significantly increases both companies’ existing commercial capacity and simplifies the supply chain process for the manufacture of viral vectors for use in gene therapy and immunotherapy, said Peter Coleman, CEO of Cobra. By aligning the technical expertise and manufacturing capabilities of Cobra and Symbiosis, the complexity, time, and risk of viral vector manufacturing projects will be greatly reduced meaning that customer companies developing viral vector ATMPs can derive their own competitive value from accelerating their progression along the drug development critical path, he added.

Read More

Advances in Cell Culture Media Formulation and Development

Genengnews | July 10, 2019

For decades commercial and academic scientists have sought reliable serum-free media. As far back as the 1960s a number of options were available for the cultivation of some cell lines. Now, after years of effort, many of the shortcomings of these early formulations have been resolved, and researchers have a number of highly successful alternatives available. For CHO bioproduction in a fed-batch process, there are two media and feed systems that we recommend. The first, the EX-CELL. Advanced CHO Fed Batch System, is optimized for fed-batch processes. The second, Cellvento. 4CHO medium and 4Feed, are unique in that the feed contains a modified form of tyrosine, which allows high concentrations of this amino acid at neutral pH. Both systems contain only chemically defined components and are animal- component free. These two media systems display high titers, protein quality, and scalability when operating in a fed-batch mode. However, if the bioproduction process is perfusion, then the nutritional needs of the cell line will be different and a medium optimized for that mode of production is essential.

Read More

Cobra Biologics and Symbiosis Complete Viral Vector Collaboration

Genengnews | July 10, 2019

Cobra Biologics, a CDMO focused on viral vector drug substance production, and Symbiosis Pharmaceutical Services, a CMO specializing in the sterile manufacture of injectable viral vector drug products, reported the successful completion of their collaboration to develop synergistic capabilities. Intended to accelerate the clinical and commercial production of viral vectors, which represent part of the burgeoning Advanced Therapeutics Medicinal Product (ATMP) drug development space and the growth of personalized medicine, the 18-month joint project saw a combined investment of £4.8m including significant support from a grant received under the U.K. government’s Innovate UK Health and Life Sciences Program. The collaboration significantly increases both companies’ existing commercial capacity and simplifies the supply chain process for the manufacture of viral vectors for use in gene therapy and immunotherapy, said Peter Coleman, CEO of Cobra. By aligning the technical expertise and manufacturing capabilities of Cobra and Symbiosis, the complexity, time, and risk of viral vector manufacturing projects will be greatly reduced meaning that customer companies developing viral vector ATMPs can derive their own competitive value from accelerating their progression along the drug development critical path, he added.

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