Enzene Biosciences Ltd.

NEWARK, Del., April 9, 2024 /PRNewswire/ -- The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce approximately $10M in planned project activities through the Institute's Project Call 7.1 for eight new technology and workforce development projects that will help address key opportunities for innovation in biopharmaceutical manufacturing. The projects align with areas of need identified by NIIMBL and industry stakeholders. "We are excited to expand our diverse project portfolio with these innovative new projects," said Chris Roberts, Associate Institute Director. "These collaborative projects will bring significant value to the biopharmaceutical industry in the key areas of intensified processing for monoclonal antibodies, viral vectors, and cell therapy, along with measurements of critical quality attributes." Among the eight projects are two workforce development projects focused on data analytics training and strengthening the pipeline of neurodiverse talent. "To help the biopharmaceutical industry meet its workforce needs, we must develop new training mechanisms and reach diverse populations. These two new additions to our workforce portfolio help us accomplish that goal," said John Balchunas, NIIMBL Workforce Director. Since the Institute's launch in 2017, NIIMBL has awarded 123 member-led technical, workforce development, and Global Health Fund projects with an approximate value of $111M. NIIMBL is composed of nearly 200 member organizations from academia, industry, government, and non-profit organization with a common goal to advance biopharmaceutical manufacturing. For a description of each project and to learn more about NIIMBL, please visit the Project Call 7.1 website. 7.1 Project List* Project: Process Intensification for rAAV Manufacturing Using HIP-Vax® and Continuous Countercurrent Tangential Chromatography Technology Lead: Batavia Biosciences Inc. Participant(s): ChromaTan Corporation Project: Antibody Mix-and-Read Assays Based on Fluorescence Intensity Probes Lead: University of Houston Participant(s): Agilent, Bristol-Myers Squibb, Genentech Project: Development of Small Molecule Formulations for Enhanced Production of CAR-T Cell Therapies Lead: Virica Biotech Inc. Participant(s): AstraZeneca, Sartorius Stedim Project: Commercial Deployment of Integrated PAT Technologies to Enable Continuous Upstream Production of Glycosylated Monoclonal Antibodies Lead: Rutgers, The State University of New Jersey Participant(s): Agilent, Endress + Hauser Optical Analysis, EnZene Biosciences Ltd, MilliporeSigma/EMD Serono, Pfizer, Inc. Project: Surrogate ADCs for Process Development and Quality Assessment Lead: Rensselaer Polytechnic Institute Participant(s): Carnegie Mellon University, Pfizer, Inc. Project: Isoelectric Point Purification (IPP) Technology Enables Truly Continuous, End-to-End Chromatography-free Manufacturing to Yield Ultra-high Purity mAbs Lead: Enquyst Technologies Inc. Participant(s): Lonza Biologics, Inc., MilliporeSigma/EMD Serono, University of Massachusetts Lowell Project: Creating a Neurodiverse Talent Pipeline for the Biomanufacturing Industry Lead: Texas A&M Engineering Experiment Station Participant(s): Janssen Research & Development, LLC, Pfizer, Inc., University of California, Los Angeles Project: BioCAD Data Programming for Biomanufacturing Scale-Up Lead: Santa Clara University Participant(s): Biocom California, Genentech, Merck Sharp & Dohme LLC *All funding is subject to project agreement negotiations. About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members. Contact: News Media Daniel Maiese Communications Manager 302-831-3824 [email protected] SOURCE National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

India-based CDMOs have detected an uptick in biopharma client interest in their biologics and early-phase clinical offerings – and these manufacturers are accordingly adjusting their growth strategy. “There’s an increase in demand. There’s a lot of factors that are going on that are influencing that,” Enzene Biosciences’ CEO Himanshu Gadgil told Endpoints News in an interview. Enzene especially has seen an increase in small to midsize biopharma clients reaching out. “We will definitely be looking at being more aggressive in terms of our expansion plan,” he added. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

DUBLIN--( BUSINESS WIRE )--The "Global Biologics Contract Manufacturing (Biopharma CDMO/Biopharma CMO/Biologics Manufacturing) Market 2022-2035 by Type of Service(s) Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size, and Key Geographical Regions" report has been added to ResearchAndMarkets.com's offering. The global biologics contract manufacturing market is estimated to reach over $19 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of ~9% during the forecast period. One of the primary objectives of the presented market report is to conduct a comprehensive market forecast analysis, aiming to estimate both the current market size and the future opportunities within the biopharmaceutical contract manufacturing sector over the next decade. Drawing insights from various parameters, anticipated adoption trends, and validated through primary research, the report offers an informed estimate of the market's evolution throughout the forecast period from 2023 to 2035. The biologics contract manufacturing market, also known as the biopharmaceutical CMO market, is a dynamic and rapidly growing sector with a large number of players investing in research and development activities for developing new modalities, such as antibody drug conjugates, biosimilars, and cell and gene therapies. With the increased interest and gradual shift of investment from small molecule drugs to biologics, over the years, more than 250 biologic therapies and vaccines have been developed globally. Notably, biologics have higher success rates than conventional small-molecule drugs owing to lesser off-target toxicity of biologics, which is one of the key reasons of failures in small molecule drugs development. Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics. In fact, biopharmaceuticals are anticipated to play a significant role in shaping the pharmaceutical industry and will eventually serve as an integral part of traditional medicines. Moreover, the exuberant development of biologics has revolutionized the treatment of a range of therapeutic conditions, which has further contributed to the exponential growth in the current demand for biologic therapies. It is worth highlighting that numerous biologics manufacturers, including biologics CMOs, have adopted digital technologies in order to enhance their productivity and reliability of existing biologics related processes and facilities. However, the complexity of biologics, as well as the integration of emerging technologies, offer challenges for current good manufacturing practices (cGMP) for biologics. Some of the key concerns of contemporary innovators include rate of attrition of pipeline drugs / therapies, long development timelines, current facility limitations, regulatory and compliance-related issues, and inconsistencies related to the quality attributes of the final product. As a result, an increasing number of biopharmaceutical drug developers are relying on contract manufacturers that are well-equipped with expertise and advanced technologies for their GMP-based manufacturing requirements. These service providers offer end-to-end solutions, including bioprocess development and optimization, to shorten operational timelines and reduce the high costs associated with the production of complex biologic drugs. In addition, there are some manufacturers that particularly outsource various operations to tap into sophisticated facilities and know-how, particularly if contract manufacturing firms are utilizing cutting-edge technologies, such as software-driven robotics, to enhance manufacturing processes and mitigate the risks and constraints associated with manual methods. With outsourcing becoming increasingly accepted as a viable and beneficial business model within this field, the global market for biologics contract manufacturing is expected to witness remarkable growth during the forecast period. This comprehensive report provides an in-depth analysis of the current landscape, market size, and future opportunities within the biologics contract manufacturing market for the forecast period. It sheds light on the contributions of various stakeholders in this rapidly evolving segment of the pharmaceutical industry. Future Of The Biopharmaceutical CMO Market Outsourcing Activities to Witness Significant Growth in the Coming Years Shift from One-time Contracts to Strategic Partnerships Integration / Adoption of New and Innovative Technologies Focus on Niche Therapeutic Areas Growing Biosimilars Market to Contribute to the Growth of the Contract Services Segment Capability Expansion by CMOs to become One-Stop-Shops Offshoring Outsourcing Activities to Maximize Profits and Expand Existing Capacities Increase in Financial Inflow and Outsourcing Budgets Challenges Faced by Sponsors and Service Providers Key Attributes: Report Attribute Details No. of Pages 799 Forecast Period 2023 - 2035 Estimated Market Value (USD) in 2023 $19.9 Billion Forecasted Market Value (USD) by 2035 $55.97 Billion Compound Annual Growth Rate 9.0% Regions Covered Global Growing Demand for Biologics Biologics, mimicking biomolecules in the human body, offer targeted treatment with fewer side effects compared to conventional drugs. This specificity makes them highly sought after in the pharmaceutical and biotechnology sectors. Novel modalities like recombinant proteins, vaccines, and cell and gene therapies are gaining traction, positioning biologics to surpass small molecules in revenue. Fundamental Advancements in Biopharmaceutical Manufacturing Single-use technologies have revolutionized biopharmaceutical manufacturing, facilitating rapid process development, particularly during the COVID-19 pandemic. Closed plug-and-play solutions allow for process intensification and continuous manufacturing, making them preferable for both developmental phases and commercial production. Competitive Landscape of Biologics Contract Manufacturing Companies The market features over 305 biologics contract manufacturing organizations (CMOs), indicating a surge in demand for manufacturing capacities. Notable players offering contract manufacturing services include 3P Biopharmaceuticals, Celltrion, Lonza, and Samsung Biologics, among others. Biologics Contract Manufacturing Market Size: North America Leading The global market for biologics contract manufacturing is estimated to exceed USD 19 billion in 2023, with North America holding the largest market share (34%). Asia-Pacific is expected to witness significant growth during the forecast period, driven by increasing R&D investments and clinical studies. Mammalian Cell Cultures Preferred for Expression Systems Mammalian cell cultures are favored for biopharmaceutical production due to their ability to perform post-translational modifications essential for drug safety and efficacy. Productivity enhancements in mammalian cell culture processes have been substantial over the past decade. Investments in Manufacturing Facilities Biologics CMOs are expanding their manufacturing capabilities to accommodate growing demand. This includes the addition of new facilities and advancements in services. Recent investments by Enzene Biosciences and Biose highlight the industry's commitment to expanding drug development and manufacturing capabilities. Market Trends Analysis: Increasing Partnerships and Collaborations Partnerships and collaborations among stakeholders are driving progress and innovation in biopharmaceutical manufacturing. More than 61% of recent deals have focused on manufacturing and development of biologics, showcasing the industry's dedication to advancing product offerings. Leading CMOs in Biologics Contract Manufacturing Key players in biologics contract manufacturing include AGC Biologics, Boehringer Ingelheim, Catalent, Lonza, and WuXi Biologics, among others. These companies offer a range of manufacturing services and have established global footprints. Recent Developments Recent initiatives, such as partnerships between 3P Biopharmaceuticals and Zhittya Genesis Medicine, and AGC Biologics and Genenta, underscore ongoing trends in the market towards innovation and collaboration. The opinions and insights presented in the market report were influenced by discussions held with stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Chief Executive Officer, Mid-Sized Company, Scotland Chief Executive Officer and Co-Founder, Small Company, Slovenia Chief Technical Officer, Large Company, USA President and Chief Operating Officer, Mid-Sized Company, China Senior Director of Global Strategic Marketing, Large Company, USA Senior Director of Commercial Strategy and Market Insights, Large Company, USA Global Head of Sales and Marketing and Head of Business Development, Large Company, USA Business Development Manager, Small Company, Spain Manager Marketing and Sales, Mid-Sized Company, Germany All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified. Key Companies Profiled AGC Biologics Boehringer Ingelheim Catalent Cell Therapies Charles River Laboratories FUJIFILM Diosynth Biotechnologies KBI Biopharma Kemwell Biopharma Lonza Miltenyi Biotec Minaris Regenerative Medicine Samsung Biologics Sandoz Vetter Pharma Wuxi Biologics For more information about this report visit https://www.researchandmarkets.com/r/9b6hx3 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.