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.

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MedTech

Next-Gen Genetics Cancer Therapies Creating Investment Prospects

Article | July 13, 2022

Genetic therapeutics such as genetic engineering and gene therapy are increasingly emerging as one of the most influential and transformed biotechnological solutions around the globe in recent times. These genetic solutions are being assessed across various medical domains, including cancer treatment, neurology, oncology, and ophthalmology. Citing the trend, the genetics industry is estimated to experience a tsunami of approvals, with over 1,000 cell and gene therapy clinical trials currently underway and over 900 companies worldwide focusing on these cutting-edge therapies. Growing Cancer Encourages Advancements in Genetic Technologies With the surging cases of cancers such as leukemias, carcinomas, lymphomas, and others, patients worldwide are increasing their spending on adopting novel therapeutic solutions for non-recurring treatment of the disease, such as gene therapy, genetic engineering, T-cell therapy, and gene editing. As per a study by the Fight Cancer Organization, spending on the treatment of cancer increased to $200.7 billion, and the amount is anticipated to exceed $245 billion by the end of 2030. Growing revenue prospects are encouraging biotechnology and biopharmaceutical companies to develop novel genetic solutions for cancer treatment. For instance, Bristol-Myers Squibb K.K., a Japanese pharmaceutical company, introduced a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Abecma, for the treatment of relapsed or refractory (R/R) multiple myeloma in 2022. Amid a New Market: Genetics Will Attract Massive Investments Despite several developments and technological advancements, genetics is still considered to be in a nascent stage, providing significant prospects for growth to the companies that are already operating in the domain. Genetics solutions such as gene therapies, gene editing, and T-cell immunotherapy are emerging as highly active treatments across various medical fields, resulting in increasing research and development activities across the domain, drawing significant attention from investors. Given the potential of genetic treatments and the focus on finding new ways to treat cancer and other related diseases, it's easy to understand why companies are investing in the domain. For instance, Pfizer has recently announced an investment of around $800 million to construct development facilities supporting gene therapy manufacturing from initial preclinical research through final commercial-scale production. Due to these advancements, cell and gene therapies are forecast to grow from $4 billion annually to more than $45 billion, exhibiting growth at a 63% CAGR. The Future of Genetics Though there is a significant rise in advancement in genetic technologies and developments, the number of approved genetic treatments remains extremely small. However, with gene transfer and CRISPR solutions emerging as new modalities for cancer treatment, the start-up companies will attract a growing amount and proportion of private and public investments. This is expected present a tremendous opportunity for biopharma and biotechnology investors to help fund and benefit from the medical industry's shift from traditional treatments to cutting-edge genetic therapeutics in the coming years.

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MedTech

Next-Gen Gene Therapy to Counter Complex Diseases

Article | October 7, 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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MedTech

Immunology: A New Frontier in Medical Science

Article | July 20, 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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Diagnostics

Making Predictions by Digitizing Bioprocessing

Article | April 20, 2021

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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Labiotech.eu is the leading digital media covering the European Biotech industry. Over 100,000 monthly visitors use it to keep an eye on the business and innovations in biotechnology. Join them now and enjoy reading our stories!

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.

Read More

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