Mesoblast’s Mesenchymal Precursor Cell (MPC) Therapy Receives Orphan Drug Designation

Mesoblast (ASX:MSB; Nasdaq: MESO) announced that the U.S. FDA granted the company’s product candidate, Revascor, Orphan Drug Designation for prevention of gastrointestinal bleeding in patients with left ventricular assist devices.

Spotlight

Select Sires Inc.

Select Sires Inc. is a federation of six farmer-owned and -controlled cooperatives. It provides highly fertile semen as well as excellence in service and programs to achieve its basic objective of supplying livestock breeders with America's best genetics at a reasonable price.

OTHER ARTICLES
Research

Making Predictions by Digitizing Bioprocessing

Article | July 11, 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

Laboratory Information Management System for Biotech Labs: Significance & Benefits

Article | October 7, 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

Expansion of BioPharma: Opportunities and Investments

Article | July 16, 2022

Biopharmaceutical innovations are among the most ingenious and refined achievements of modern medical science. New concepts, techniques, and therapies are emerging, such as the cell therapy Provenge, which can be used to treat cancer, and gene therapies, which provide even more amazing promises of disease remission and regenerative medicine. In addition, the COVID-19 pandemic has caused a huge boom in the pharmaceutical industry. This is because more and more attention is being paid to increasing manufacturing capacity and starting new research on drug development. Biopharma: Leading the Way in the Pharma Sector In the past couple of years, the biopharmaceutical sector has deepened its roots across the medical and pharmaceutical industries, on account of the transformation of pharmaceutical companies towards biotechnology, creating opportunities for growth. Also, growing advancements in technologies such as 3D bioprinting, biosensors, and gene editing, along with the integration of advanced artificial intelligence and virtual and augmented reality are estimated to further create prospects for growth. According to a study, the biopharmaceutical sector makes nearly $163 billion around the world and grows by more than 8% each year, which is twice as fast as the traditional pharma sector. Massive Investments Directed Towards Biopharma Investing in biotech research and development (R&D) has yielded better returns than the pharma industry average. Hence, a number of pharmaceutical companies are shifting their presence toward biopharma to capitalize on the upcoming opportunities by investing in and expanding their biotechnology infrastructure. For instance, Thermo Fisher Scientific Inc., an American manufacturer of scientific instrumentation, reagents and consumables, and software services, announced an investment of $97 million to expand its bioanalytical laboratory operations into three new locations in the U.S. With this investment, the company will add 150,000 square feet of scientific workspace and install the most advanced drug development technologies to produce life-changing medicines for patients in need.

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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

Select Sires Inc.

Select Sires Inc. is a federation of six farmer-owned and -controlled cooperatives. It provides highly fertile semen as well as excellence in service and programs to achieve its basic objective of supplying livestock breeders with America's best genetics at a reasonable price.

Related News

Cell and Gene Therapy

iTolerance to Collborate with LyGenesis for Joint Research

iTolerance | July 01, 2022

iTolerance, Inc., an early-stage privately held regenerative medicine company developing technology to enable organoid, tissue, and cell therapy, announced entering into a joint collaboration with LyGenesis, Inc., a clinical-stage biotechnology company with an organ regeneration technology platform. The joint collaboration is aimed at evaluating the potential of iTOL-201, a product candidate being developed combining LyGenesis' LYG-LIV-100 liver cell therapy and iTolerance's SA FasL microgel immune tolerance platform to permit the growth of ectopic livers without the requirement for immune suppression. The joint research effort of iTolerance and LyGenesis has produced in vitro data using iTOL-201 and is now moving toward small animal proof of concept work to assess the potential of the combined technology for producing ectopic livers capable of saving the animals from fatal liver disorders without the requirement for immune suppression. With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work." Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis. While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration, As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve." Dr. Anthony Japour, Chief Executive Officer of iTolerance.

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Medical

Anitoa Launches Molecular Test (PCR) for Monkeypox

Anitoa | June 30, 2022

Anitoa Systems, market leader in fast, portable molecular testing, today announced the availability of a CE-marked turn-key PCR solution for testing Monkeypox. This portable solution includes one of a family small foot-print real time PCR instruments called the Maverick qPCR, with an extraction-free multiplex PCR reagent that tests OPXV/MPXV gene-targets in the skin lesion sample from patients suspected of infection with Monkeypox. Anitoa's Monkeypox test is designed to be carried out on-site, near patient, thus avoiding the need to transport patient samples to central labs for testing. The World Health Organization reported that over 2,100 people in 42 countries have been diagnosed with monkeypox as of June 15, nearly all during the past two months. As of June 17, the CDC reports 24 confirmed monkeypox cases in California, US. Although The CDC reports that the threat to the general U.S. population is considered low, it is important for healthcare providers worldwide to have a preparedness plan. Already having a presence in Africa, Anitoa Systems has started deloying its near-patient Monkeypox test in selected clinics in Africa. Anitoa is prepared to deliver its Monkeypox test solution world-wide when the need arises. Anitoa's Maverick line of multiplex real time PCR devices are lab-accurate, fast, portable and calibration-free. They can operate on battery power (including car battery) and takes up very little bench space. Maverick qPCR instruments are built on Anitoa's proprietary CMOS biosensor technology. They have been used widely for on-site testing of food, environment samples and agriculture products due to its rugged all solid-state design, small form factor, and lower operation cost. Anitoa's Monkeypox detection solution is part of an on-going program at Anitoa to develop tests to help combat a series of neglected tropical diseases in low resource settings. These tests currently include IVDR tests for Dengue, Yellow Fever, and Malaria We are closely monitoring the situation of Monkeypox infections around the world and tailoring our test solutions to the needs of the people affected." Zhimin ding, CEO of Anitoa Systems, LLC About Anitoa Anitoa Systems, a medical device technology start-up established in 2013 with headquarter in Sunnyvale, California, develops highly integrated and portable bio-sensor devices for molecular detection, based on its unique CMOS image sensor-based fluorescence and chemiluminescence molecular imaging. By replacing the traditional bulky and costly photon-multiplier tube (PMT) and CCD-based optical sub-systems, Anitoa's ultra-low-light CMOS sensor technology enables a new generation of compact and inexpensive molecular testing platforms targeting infectious, oncology and cardio-vascular markers. Anitoa manufactures its qPCR instruments and test kits in Hangzhou, China and Fremont, California.

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Medical

Hillstream BioPharma to Announce Collaborating with Sapien Biosciences

Hillstream | June 30, 2022

Hillstream BioPharma, Inc., a U.S.-based biotechnology company developing novel therapeutic candidates targeting ferroptosis for cancer treatment, announced a collaboration with an Indian pioneer biobank and peonalized medicine company that leverages Saarum Innovation's global life sciences research expertise, Sapien Biosciences. The collaboration is aimed at assessing the compatibility of HSB-1216 with immune checkpoint inhibitors. HSB-1216, Hillstream’s most advanced candidate, is an IMCD modulator that targets various types of solid tumors. In an exhaustive study in Germany, the active drug in HSB-1216 was found to be efficacious in a clinical pilot for devastating cancers, including epithelial carcinomas and triple-negative breast cancer. Hillstream aims to build an early clinical proof-of-concept by beginning a clinical investigation with HSB-1216 in 2022. With this collaboration, Hillstream will be able to use Sapien’s patient samples and rich datasets to validate its HSB-1216 for the development of novel cancer therapeutics. We are initiating studies, in collaboration with Sapien Biosciences, to determine the synergy between HSB-1216, our ferroptosis inducer and nivolumab, an anti-PD1 antibody.” He stated, “In addition, we will also study the potential synergistic effects of HSB-1216 with the recently approved Bristol Myers Squibb drug Opdualag® (nivolumab + relatlimab), a fixed dose combination of an anti-PD1 MAb + anti-LAG3 MAb, to demonstrate that targeting a ferroptosis-associated metabolism in tumors may improve the efficacy of cancer immunotherapy.” Randy Milby, Hillstream’s Chief Executive Officer. We are excited to extend our collaboration with Hillstream Biopharma to evaluate potential synergy between their HSB-1216 molecule and ICIs using our expertise in establishing patient tissue-derived cell models in oncology, immunology and Immune-oncology Previously, Sapien demonstrated potent anti-cancer activity of HSB-1216 in primary triple negative breast cancer cells which were presented at AACR 2020.” Dr. Jugnu Jain, CEO, Sapien Biosciences.

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Cell and Gene Therapy

iTolerance to Collborate with LyGenesis for Joint Research

iTolerance | July 01, 2022

iTolerance, Inc., an early-stage privately held regenerative medicine company developing technology to enable organoid, tissue, and cell therapy, announced entering into a joint collaboration with LyGenesis, Inc., a clinical-stage biotechnology company with an organ regeneration technology platform. The joint collaboration is aimed at evaluating the potential of iTOL-201, a product candidate being developed combining LyGenesis' LYG-LIV-100 liver cell therapy and iTolerance's SA FasL microgel immune tolerance platform to permit the growth of ectopic livers without the requirement for immune suppression. The joint research effort of iTolerance and LyGenesis has produced in vitro data using iTOL-201 and is now moving toward small animal proof of concept work to assess the potential of the combined technology for producing ectopic livers capable of saving the animals from fatal liver disorders without the requirement for immune suppression. With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work." Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis. While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration, As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve." Dr. Anthony Japour, Chief Executive Officer of iTolerance.

Read More

Medical

Anitoa Launches Molecular Test (PCR) for Monkeypox

Anitoa | June 30, 2022

Anitoa Systems, market leader in fast, portable molecular testing, today announced the availability of a CE-marked turn-key PCR solution for testing Monkeypox. This portable solution includes one of a family small foot-print real time PCR instruments called the Maverick qPCR, with an extraction-free multiplex PCR reagent that tests OPXV/MPXV gene-targets in the skin lesion sample from patients suspected of infection with Monkeypox. Anitoa's Monkeypox test is designed to be carried out on-site, near patient, thus avoiding the need to transport patient samples to central labs for testing. The World Health Organization reported that over 2,100 people in 42 countries have been diagnosed with monkeypox as of June 15, nearly all during the past two months. As of June 17, the CDC reports 24 confirmed monkeypox cases in California, US. Although The CDC reports that the threat to the general U.S. population is considered low, it is important for healthcare providers worldwide to have a preparedness plan. Already having a presence in Africa, Anitoa Systems has started deloying its near-patient Monkeypox test in selected clinics in Africa. Anitoa is prepared to deliver its Monkeypox test solution world-wide when the need arises. Anitoa's Maverick line of multiplex real time PCR devices are lab-accurate, fast, portable and calibration-free. They can operate on battery power (including car battery) and takes up very little bench space. Maverick qPCR instruments are built on Anitoa's proprietary CMOS biosensor technology. They have been used widely for on-site testing of food, environment samples and agriculture products due to its rugged all solid-state design, small form factor, and lower operation cost. Anitoa's Monkeypox detection solution is part of an on-going program at Anitoa to develop tests to help combat a series of neglected tropical diseases in low resource settings. These tests currently include IVDR tests for Dengue, Yellow Fever, and Malaria We are closely monitoring the situation of Monkeypox infections around the world and tailoring our test solutions to the needs of the people affected." Zhimin ding, CEO of Anitoa Systems, LLC About Anitoa Anitoa Systems, a medical device technology start-up established in 2013 with headquarter in Sunnyvale, California, develops highly integrated and portable bio-sensor devices for molecular detection, based on its unique CMOS image sensor-based fluorescence and chemiluminescence molecular imaging. By replacing the traditional bulky and costly photon-multiplier tube (PMT) and CCD-based optical sub-systems, Anitoa's ultra-low-light CMOS sensor technology enables a new generation of compact and inexpensive molecular testing platforms targeting infectious, oncology and cardio-vascular markers. Anitoa manufactures its qPCR instruments and test kits in Hangzhou, China and Fremont, California.

Read More

Medical

Hillstream BioPharma to Announce Collaborating with Sapien Biosciences

Hillstream | June 30, 2022

Hillstream BioPharma, Inc., a U.S.-based biotechnology company developing novel therapeutic candidates targeting ferroptosis for cancer treatment, announced a collaboration with an Indian pioneer biobank and peonalized medicine company that leverages Saarum Innovation's global life sciences research expertise, Sapien Biosciences. The collaboration is aimed at assessing the compatibility of HSB-1216 with immune checkpoint inhibitors. HSB-1216, Hillstream’s most advanced candidate, is an IMCD modulator that targets various types of solid tumors. In an exhaustive study in Germany, the active drug in HSB-1216 was found to be efficacious in a clinical pilot for devastating cancers, including epithelial carcinomas and triple-negative breast cancer. Hillstream aims to build an early clinical proof-of-concept by beginning a clinical investigation with HSB-1216 in 2022. With this collaboration, Hillstream will be able to use Sapien’s patient samples and rich datasets to validate its HSB-1216 for the development of novel cancer therapeutics. We are initiating studies, in collaboration with Sapien Biosciences, to determine the synergy between HSB-1216, our ferroptosis inducer and nivolumab, an anti-PD1 antibody.” He stated, “In addition, we will also study the potential synergistic effects of HSB-1216 with the recently approved Bristol Myers Squibb drug Opdualag® (nivolumab + relatlimab), a fixed dose combination of an anti-PD1 MAb + anti-LAG3 MAb, to demonstrate that targeting a ferroptosis-associated metabolism in tumors may improve the efficacy of cancer immunotherapy.” Randy Milby, Hillstream’s Chief Executive Officer. We are excited to extend our collaboration with Hillstream Biopharma to evaluate potential synergy between their HSB-1216 molecule and ICIs using our expertise in establishing patient tissue-derived cell models in oncology, immunology and Immune-oncology Previously, Sapien demonstrated potent anti-cancer activity of HSB-1216 in primary triple negative breast cancer cells which were presented at AACR 2020.” Dr. Jugnu Jain, CEO, Sapien Biosciences.

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