Saiba AG Selects AGC Biologics to Develop and Produce COVID-19 Vaccine

AGC Biologics | June 16, 2020

AGC Biologics, a global biopharmaceutical Contract Development Manufacturing Organization (CDMO), has announced it will be partnering with Saiba AG to manufacture a SARS-CoV-2 vaccine to protect against COVID-19. Saiba AG is a Swiss biotechnology company that specializes in the research and development of virus-like particle (VLP) vaccines for infectious and chronic diseases. Saiba AG is leveraging its patented Cucumber Mosaic Virus VLP platform technology to develop the SARS-CoV-2 vaccine. The recombinant subunit VLP vaccine not only has the potential to rapidly deliver an effective and safe prophylaxis for COVID-19, but also an economic, scalable, high-yield and large-scale production capability. These are key assets for addressing the current pandemic and predicted global vaccine supply issues. The vaccine has been engineered to enhance immune responsiveness in elderly people, a high-risk group for COVID-19.

Spotlight

Demand for non-GMO food is high. But what qualifies as a genetically modified organism isn't always clear. One San Diego biotech has developed new ways of altering plant DNA while still avoiding the GMO label. KPBS science reporter David Wagner explains.

Spotlight

Demand for non-GMO food is high. But what qualifies as a genetically modified organism isn't always clear. One San Diego biotech has developed new ways of altering plant DNA while still avoiding the GMO label. KPBS science reporter David Wagner explains.

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MEDICAL

Resilience and MD Anderson Launch Joint Venture to Accelerate Development and Manufacturing of Innovative Cell Therapies for Cancer

Resilience | June 07, 2022

National Resilience, Inc. (Resilience) and The University of Texas MD Anderson Cancer Center today announced the launch of a joint venture, the Cell Therapy Manufacturing Center, to accelerate the development and manufacturing of innovative cell therapies for patients with cancer. Uniting the strengths of Resilience and MD Anderson, the joint venture will advance its work within a culture of academic innovation alongside industrial expertise. The Cell Therapy Manufacturing Center will be based in a state-of-the art 60,000-square-foot manufacturing facility in the Texas Medical Center, with a team of 70 employees focused on process and analytical development as well as early-phase and clinical-stage Good Manufacturing Practices (GMP). The joint venture combines MD Anderson’s expertise in immunotherapy and cell therapies as well as a leading clinical trials infrastructure, with Resilience’s innovative biomanufacturing technologies, advanced analytics and a national network for developing and producing cell therapies. Together, the parties aim to accelerate the path of cell therapies to the clinic, while enabling scalability and a smooth transition to late-phase clinical and commercial activities. Cell therapies have had a dramatic impact for patients with certain cancers, but progress has been hampered by structural challenges, This novel joint venture was conceived to address those challenges by harnessing the complementary capabilities of two world-class organizations, allowing us to advance innovative programs to deliver impactful therapies to patients.” Jason Bock, Ph.D., Chief Executive Officer of the Cell Therapy Manufacturing Center. The joint venture will engage with MD Anderson researchers and external industry collaborators to advance new therapies through preclinical and clinical development, ensuring consistent and safe products that can be evaluated rapidly in clinical trials led by MD Anderson physicians. Resilience customers will be able to leverage this offering as part of the company’s growing network of biomanufacturing facilities that are flexible enough to scale projects from small-batch pre-clinical to large-scale commercial production. Resilience has 10 facilities across North America, with more than 1 million square feet of manufacturing space. The promise of cell therapies to help patients in need has been limited by a lack of innovation in biomanufacturing, This collaboration aims to overcome those hurdles by extending our network with this unique partnership, creating opportunities to incubate innovative ideas and provide cutting-edge biomanufacturing technologies and processes to researchers, with a goal of bringing more cell therapies to patients.” Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. The joint venture will advance the most promising cell therapy modalities to answer unmet clinical needs, including engineered tumor infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified T cells, endogenous T cells (ETCs), engineered natural killer (NK) cells and other emerging technologies, for patients with hematological and solid tumors. MD Anderson researchers are leaders in the field of cancer cell therapy, responsible for advancing the translational and clinical development of many of the currently approved and experimental cell therapies. The joint venture is built upon MD Anderson’s Biologics Development platform, formerly part of the institution’s Therapeutics Discovery division. Current strategic collaborations with MD Anderson’s Biologics Development platform will continue; collaborative relationships with MD Anderson’s Therapeutics Discovery division, as well as physicians and scientists across the institution, also will be maintained. We believe in the tremendous potential of cell therapies to deliver solutions that offer cures, not merely prolonged survival. Resilience offers unique capabilities that make it an ideal choice for unlocking that potential and accelerating impactful cell therapies, Our mission at MD Anderson is to end cancer, and this joint venture is a strategic step toward realizing that goal.” Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. About Resilience Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development.

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MEDTECH

BeiGene Announces Strategic Alliance with Ontada to Improve U.S. Community Oncology Care

BeiGene | August 16, 2022

BeiGene a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide, today announced a strategic agreement with Ontada®, a McKesson business with leading provider technology and actionable real-world research, education, and evidence in oncology, to improve U.S. community oncology care through the development of real-world evidence data, tools, and insights to help increase access to affordable, cutting-edge therapies. The partnership will be led by Ontada and focus on accelerating the development and implementation of RWE to improve community education on the financial impact and value of oncolytics as well as improve patient access to oncology medicines. “BeiGene is excited to work with Ontada to advance our shared vision of improving patient access, affordability, and value for community oncology stakeholders and key partners working at the intersection of clinical practice and real-world evidence. Working together, BeiGene and Ontada will generate novel oncology insights through real-world data, tools, and technologies that will facilitate the acceleration of precise decision-making in support of community oncology practices whose ultimate mission is to improve patient outcomes.” Josh Neiman, Chief Commercial Officer, North America and Europe, at BeiGene As part of the collaboration, the companies will optimize the use of RWE to communicate value across key stakeholders including patients, providers, and payers; develop timely education on emerging science and therapeutic differentiation; and collaborate to advance use of RWE in healthcare and regulatory decision making to increase timely and affordable patient access to life-saving oncology therapies. “BeiGene aims to bring 10 molecules per year to the clinic starting in 2023 and, as this research advances, we’re delighted to form this strategic partnership with McKesson, which shares the same vision as BeiGene for improving the care of cancer patients,” said Christiane Langer, M.D., Senior Vice President of Global Medical Affairs, Ex-China, at BeiGene. “This collaboration will leverage Ontada’s technology platform and deep understanding of the experiences of patients treated in community oncology clinics to help accelerate both the development of the BeiGene portfolio and expand access to treatment options.” “As a leader in real-world research, Ontada is uniquely positioned to support complex research that uncovers deeper patient insights and perspectives that advance cancer care,” said Susan Shiff, Ph.D., president of Ontada. “We are excited to announce this unique partnership with BeiGene and look forward to developing a stronger understanding of how to better treat oncology patients through the use of real-world data and evidence.” About Ontada® Ontada is an oncology technology and insights business dedicated to transforming the fight against cancer. Part of McKesson Corporation, Ontada was founded on the core belief that precise insights – delivered exactly at the point of need – can save more patients’ lives. We connect the full patient journey by combining technologies used by The US Oncology Network and other community oncology providers with real-world data and research relied on by all top 15 global life sciences companies. Our work helps accelerate innovation and power the future of cancer care. About McKesson Corporation McKesson Corporation is a diversified healthcare services leader dedicated to advancing health outcomes for patients everywhere. Our teams partner with biopharma companies, care providers, pharmacies, manufacturers, governments, and others to deliver insights, products and services to help make quality care more accessible and affordable. Learn more about how McKesson is impacting virtually every aspect of healthcare at McKesson.com and read Our Stories. BeiGene Oncology BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA® in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-Fc-gamma receptor binding anti-PD-1 antibody, tislelizumab, as well as the PARP inhibitor, pamiparib, in China. BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks. In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North America, Europe, and Japan. Building upon this productive collaboration, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor, ociperlimab, that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China. About BeiGene BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 8,500 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland.

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MEDICAL

GE Healthcare Introduces Wireless Patient Monitoring Solution to Help Clinicians Detect Early Patient Deterioration

GE | June 20, 2022

With most hospitals around the world currently relying on manual “spot-checks” to monitor patient vitals, GE Healthcare unveils Portrait Mobile3, a wireless patient monitoring system that enables continuous monitoring throughout a patient’s stay. The system helps clinicians detect patient deterioration. Early detection of patient deterioration may help reduce length of stay and intensive care unit (ICU) admissions – and improve patient outcomes4. Portrait Mobile includes patient-worn wireless sensors which communicate with a mobile monitor. Globally, an estimated 65 percent of hospital patients and over 90 percent of post-acute care patients are monitored manually and not continually.5 Many vital sign changes are missed during spot checks which often occur in four-to-six-hour intervals6. A UK national audit of adult in-hospital cardiac arrests showed that more than half (57 percent) occurred on the wards and only five percent in the ICU7 where patients are monitored continuously. Most patients who end up in cardiac arrest or critical care, don’t suddenly deteriorate but rather present with earlier vital signs that show abnormal trends8. Respiratory rate is the highest ranked variable in models predicting clinical deterioration in the hospital9. With Portrait Mobile, respiration rate, oxygen saturation and pulse rate for general ward and post-surgery patients can be captured wirelessly, continuously. This innovation allows caregivers to identify changes that may signal that cardiorespiratory complications or infectious disease may be developing. It gives clinicians the opportunity to act early and potentially avert serious adverse events. In an evaluation clinical study conducted at a London hospital in the UK, 90 percent of nurses reported that they feel more reassured about their patient’s condition when continuous monitoring is used versus vital signs spot check measuring, Portrait Mobile provides reliable measurement technology and meaningful alarms in a mobile setting.” Erno Muuranto, Engineering Director at GE Healthcare in Finland. For patients, Portrait Mobile’s wireless continuous monitoring helps with the ability to move about the hospital, without being restricted to the bedside. This also allows visitors to interact with the patient without technology getting in the way. Moreover, the solution provides patients and family members peace of mind knowing that monitoring is constant - even when the patient is out of their room. Patient mobility may help improve patient outcomes and reduce length of stay, which may lower costs and elevate patient satisfaction10. Portrait Mobile is designed to be as reliable as wired technology. Its routable communications architecture enables hospitals to leverage their existing network infrastructure when deploying the system, reducing installation and maintenance costs. Portrait Mobile was developed in Helsinki, GE Healthcare’s global center of excellence for monitoring solutions where engineers have been developing patient monitoring technology for decades. Today, GE monitors are used in hospitals across the world - from Beijing to London, New York, and more. About GE Healthcare: GE Healthcare is the $17.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 48,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

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