MEDTECH

Avantor® will Increase Global Production of Single-Use Technologies to Meet the Biopharma Demand

Avantor | April 27, 2021

Avantor Inc., a main worldwide supplier of crucial items and administrations to clients in the existing sciences, trend-setting innovations, and applied materials businesses, today declared that it will increment worldwide limit with regards to top-notch single-use advances utilized in the creation of biologics and antibodies.

In the U.S. what's more, in Europe, the Company will build its single-use producing impression by 30% and twofold its cleanroom space. The speculation will uphold developing client interest for monoclonal antibodies (mAbs), novel cell and quality treatments for oncology and different illnesses, just as immunizations, including those for COVID-19.

Avantor as of late extended its Morrisville, North Carolina, single-use office and expects finish of a cleanroom extension at its Devens, Massachusetts, activity by mid-year. The Company likewise hopes to open its subsequent European single-use office in Hillegom, the Netherlands, by then too.

Dr. Ger Brophy, Executive Vice President of Biopharma Production at Avantor, said, "The business' reaction to the COVID-19 pandemic has depended intensely on the incorporation of single-use items into biopharma creation measures. Adequacy and security are critical to our clients, and they look to us to comprehend and uphold their prerequisites as they quickly extend their assembling limit.

"These options to our worldwide single-use fabricating biological system are basic strides in empowering our clients to get treatments to patients rapidly," Brophy added.

The speculation further fortifies the Company's single-use organization, giving item consistency and abilities near bioproduction clients to help guarantee productive and continuous stock.

About Avantor
Avantor®, a Fortune 500 organization, is a main worldwide supplier of strategic items and administrations to clients in biopharma, medical care, training and government, and trendsetting innovations and applied materials enterprises. Our portfolio is utilized in essentially every phase of the main examination, advancement, and creation exercises in the enterprises we serve. Our worldwide impression empowers us to serve more than 225,000 client areas and gives us broad admittance to explore research facilities and researchers over 180 nations. We set science underway to make a superior world.

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CELL AND GENE THERAPY

Eiger BioPharmaceuticals Provides Update on Plans for Emergency Use Authorization Application Following FDA Feedback

Eiger BioPharmaceuticals, Inc. | October 06, 2022

Eiger BioPharmaceuticals, Inc. a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus and other serious diseases, today announced that, following feedback from the U.S. Food and Drug Administration the company will not submit an emergency use authorization application of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19. Following Eiger's press release on September 6, 2022, the company submitted a pre-EUA meeting request to FDA, as well as additional morbidity and mortality outcomes data and analyses from the investigator-sponsored TOGETHER study. This included further statistical modeling and efficacy analyses of the study's primary and secondary endpoints and long-term follow-up data that the company believes continue to support the initial positive topline outcomes reported in March. In response, FDA denied the request for a pre-EUA meeting. Citing its concerns about the conduct of the TOGETHER study, FDA concluded that any authorization request based on these data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic. FDA suggested that, given peginterferon lambda's mechanism of action and the ongoing need for improved COVID-19 therapeutics, Eiger consider requesting an end-of-Phase 2 meeting to discuss a company-sponsored pivotal trial that could support an eventual Biologics License Application. Eiger is evaluating next steps for this program, in the U.S., as well as ex-U.S. emergency use authorization pathways and strategic options for continued development of peginterferon lambda for COVID-19 and other respiratory viral infections. "While we are disappointed that FDA will not consider an EUA application based on results generated from the TOGETHER study, we continue to have strong conviction in the potential of peginterferon lambda to confer a meaningful benefit for patients with COVID-19 and other respiratory viral infections. COVID-19 related deaths remain alarmingly high around the globe, including in the U.S. where, according to recent data from the Centers for Disease Control and Prevention, approximately 400 people die every day from this disease." David Cory, President and CEO, Eiger Eiger is advancing a late-stage pipeline of multiple FDA Breakthrough Therapy designated programs in Phase 3, including lonafarnib and peginterferon lambda for hepatitis delta virus (HDV) infection, and avexitide for congenital hyperinsulinism. The company expects to report topline data from D-LIVR, Eiger's landmark Phase 3 study of lonafarnib-based regimens for HDV, by year end. About TOGETHER Study TOGETHER is an independent multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating therapeutics in newly diagnosed, high-risk, non-hospitalized patients with mild-to-moderate COVID-19. TOGETHER is the largest placebo-controlled study in COVID-19 and has evaluated 11 different therapeutic agents for non-hospitalized COVID-19 patients. The study was ongoing at the time the peginterferon lambda arm was added. The evaluation of peginterferon lambda versus placebo was the second largest study to date of a COVID-19 therapeutic of > 1,900 patients. Eligibility criteria required that all patients had laboratory-confirmed mild or moderate COVID-19 and were randomized within seven days of symptom onset. The study enrolled patients regardless of vaccination status or variant strain of SARS-CoV-2. The primary endpoint was a reduction in risk of clinical outcome comparing hospitalizations or emergency room visits greater than six hours after a single subcutaneous injection of peginterferon lambda versus placebo through Day 28. A key secondary endpoint was reduction in risk of hospitalizations or death in patients when dosed within three days of symptom onset. The TOGETHER study recruited from 12 sites in Brazil and 5 sites in Canada. About Peginterferon Lambda Peginterferon lambda is an investigational late-stage, first-in-class, type III interferon that stimulates immune responses that are critical for the development of host protection during viral infections and has been well-tolerated in clinical studies. Eiger is developing peginterferon lambda for the treatment of HDV infection. Peginterferon lambda has been administered to over 4,000 subjects in 28 clinical trials of HBV, HCV, HDV and COVID-19. Peginterferon lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation by the U.S. Food and Drug Administration and European Medicines Agency, and Fast Track and Breakthrough Therapy Designation by FDA for peginterferon lambda in HDV. About Eiger Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.

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INDUSTRIAL IMPACT

Versant Ventures Collaborates with AbCellera to Accelerate Drug Development for its Portfolio of Biotech Companies

AbCellera and Versant Ventures | July 28, 2022

AbCellera and Versant Ventures announced a multi-year collaboration to discover therapeutic antibodies for multiple targets selected by Versant’s portfolio of biologics-focused biotechs. Versant and AbCellera already have enabled three of the firm’s stealth-stage companies under previous partnerships. Under the terms of the deal, Versant portfolio companies will have rights to develop and commercialize the resulting therapeutic antibodies. AbCellera will receive research payments from the companies and will be eligible to receive downstream clinical and commercial milestone payments plus royalties on net sales of products. Further terms are not disclosed. "In recent years we have made a series of investments into the next generation of therapeutic antibodies. We are seeing a wave of innovation in the antibody space that is allowing us to add novel functionalities to these molecules. Our partnership with AbCellera will further enable our portfolio companies to pursue these important biologic medicines.” Markus Enzelberger, Ph.D., a partner at Versant “AbCellera’s discovery technology provides a complete solution for antibody therapeutics that unlocks new opportunities and levels the playing field for smaller companies, allowing them to advance programs faster, more efficiently and with a competitive advantage,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “We are excited to deepen our relationship with the Versant team and look forward to helping them continue a strong track record of bringing together breakthrough science, experienced teams, and capital to create bold new biotech companies.” Previously, Versant and AbCellera partnered in separate multi-target deals to enable three of the firm’s stealth-stage companies with new approaches to optimize and expand antibody therapies. These include antibody-focused newcos in the fields of immunology and oncology based in Canada, the U.S. and Europe. About Versant Ventures Versant Ventures is a leading healthcare venture capital firm committed to helping exceptional entrepreneurs build the next generation of great companies. The firm’s emphasis is on biotechnology companies that are discovering and developing novel therapeutics. With $4.2 billion under management and offices in the U.S., Canada and Europe, Versant has built a team with deep investment, operating and R&D expertise that enables a hands-on approach to company building. Since the firm’s founding in 1999, more than 85 Versant companies have achieved successful acquisitions or IPOs. About AbCellera Biologics Inc. AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.

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INDUSTRIAL IMPACT

BioConsortia Showcases Breakthrough Microbial Products and Pipeline of Innovation

BioConsortia, Inc. | September 05, 2022

BioConsortia’s innovative microbial products and technical capabilities were on full display August 30th at its Davis, CA headquarters in an investor-focused Technology Showcase event. BioConsortia demonstrated rapid advancements in microbial product and pipeline developments for reducing nitrogen fertilizers, controlling soil pests and plant diseases for larger and better-quality crop yields, as well as protecting crops post-harvest to avoid food waste, while minimizing environmental impact and protecting our planet. The Showcase event reintroduced CRIMSON™ fungicide and biostimulant ZAFFRE™, two products currently awaiting final registrations, and highlighted BioConsortia’s new fungicides, nematicides and nitrogen fixing products that are progressing through registration and commercialization and moving into evaluation with potential partners, as follows: NO-NEM™ bionematicide advances: BioConsortia highlighted progress in bringing novel, safe and effective nematocidal microbes to market. Experts estimate global crop losses of $125 billion or 14% of crop value each year. Currently available chemical controls like methyl bromide, organophosphates and carbamates have an unacceptable level of toxicity to non-target organisms and are being withdrawn from use. NO-NEM is BioConsortia’s first nematicide product heading into full development phase. It has shown excellent performance against economically important pests in row crops, as well as fruits and vegetables, such as soybean cyst nematodes and root knot nematodes. “Today we highlight the breadth of innovations developed to replace chemical crop inputs with superior microbe-based solutions for nitrogen fixing, disease control, nematode control, crop yields and post-harvest food safety. The recent progress of our pipeline – including some exciting technology breakthroughs - means we are ready to advance multiple major products into the commercialization phase with marketing partners.” Marcus Meadows-Smith, CEO of BioConsortia R&D Pipeline Expanded through Technical Innovation Additions to BioConsortia’s R&D pipeline aim to leapfrog currently available microbial products, providing improved efficacy, increased shelf-stability, and reduced field use rates, as follows Leveraging GenePro™ microbe editing platform for nitrogen-fixing breakthroughs: BioConsortia’s proprietary genomics and gene-editing platform, GenePro™, facilitates the discovery and engineering of a wide diversity of microbes faster and more efficiently. BioConsortia’s scientists affirmed GenePro has resulted in the discovery of novel genetic components driving nitrogen-fixation. BioConsortia’s proprietary bacterial strains fix nitrogen under conditions other N-fixing strains will not. This discovery validates the company’s position as a leader in microbe-derived alternatives for agriculture, has resulted in proprietary intellectual property, and will continue to drive our research focus. Expanding library through AMS: BioConsortia’s patent-protected “AMS” - Advanced Microbial Selection™ platform uses evolutionary biology practices to find beneficial microbes that the plant has selected for specific gains. AMS underpins the breadth, depth, and success of BioConsortia’s product pipeline. The company announced the addition of more than 2000 rice diazotrophic microbial strains to its library, following a research program using AMS. This large addition to the library has greatly accelerated BioConsortia’s nitrogen-fixation project for rice, a crop with a paddy production model that represents a unique opportunity to impact the sustainability practices of both large and small growers of one of the world’s most fertilized crops. Novel Bactericide Project: BioConsortia also introduced a new project focused on optimizing microbes for the production of metabolites active against bacterial disease. Project leaders highlighted early technological success within this project – again reliant on the GenePro platform, which focuses on utilizing novel tools to address evolving bacterial disease resistance and increasing bacterial pest pressure resulting from climatic challenges and global trade flows. Novel Multi-spectrum Insecticide: Additionally, the company updated progress on a novel, developmental microbial active ingredient designed to deliver broad-spectrum control of both nematodes and critically important coleopteran and lepidopteran pests. The project aims to deliver a novel mode of action to support and extend crop trait lifecycles in the face of emerging insect resistance. Nematicide leads were originally characterized as strong root colonizers employing the company’s RhizoViz™ system, which uses proteins to visualize colonization robustness in different soils and environmental conditions. BioConsortia’s nematicide pipeline is now among the most expansive in agricultural research. “BioConsortia’s pipeline progress highlights the strengths of the company’s R&D platform – unique in the industry in terms of discovery of plant-affiliated microbes and their optimization as solutions for agriculture,” said Dr. Hong Zhu, Senior VP of Research and Development at BioConsortia. About BioConsortia BioConsortia, Inc. develops superior microbial products that protect plants, enhance fertility, and increase yields while improving the sustainability of agriculture for our environment. Pioneering the use of directed selection within microbial communities, our patented Advanced Microbial Selection process and cutting-edge GenePro genomics and gene-engineering platform enable us to predict, design, and unleash the natural power of microbes.

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