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Bioprocess Online for bioanalytics, biopurification, bioproductionBioprocess Online bioanalytics, bioreactors,bioprocess sensors, cell culture media,immunochemicals, chromatography, cell culture media, biopharm contract manufacturingBioprocess Online for bioanalytics, biopurification, bioproduction Get more Bioprocess insight with our FREE newsletter sign me up Log In or Subscribe Manufacturing Upstream Downstream Logistics Facility Design Find A Partner Cell Culture Media Fermentation Filtration Fluid Management Purification Listen & Watch The Business Of Biotech Podcast Bioprocess Online Live Bio-Expo Live Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization. FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals The Peril Of Analytical Methods Transfer How To Leverage Platform And Process Characterization Data To Accelerate Cell & Gene Therapies Complex Protein Development: Assay Early, Assay Often Wish SUS Cost Less? Survey Says Your Peers Do, Too Capacity, AI Driving Single-use Bioprocess Probe And Sensor Uptake A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions Delivering Large Molecules To The CNS, Overcoming The Blood-Brain Barrier Luxturna Maker Spark Therapeutics' Flexible Platform Approach EDITOR'S DESK Key Takeaways From The 2024 Bioprocessing Summit Editor Tyler Menichiello reflects on the topics and trends covered at this year's Bioprocessing Summit in Boston. The ADC Market Is Ripening For Disruption Where there is therapeutic demand, the industry will build capacity. But with ADCs, cytotoxic payloads and a fragmented contract manufacturing landscape make the path to clinical and commercial supply dauntingly complicated. Here's how the ADC manufacturing market is shaping up, and how it might ultimately shake out. Are You Taking The HPCs In Your ADCs Seriously? The wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design. Are Bioprocess Equipment Standards A One-Sided Conversation? Half of respondents to a recent survey of biopharmaceutical companies said the greatest challenge in further growing industry acceptance of single-use technology—which now comprises an eye-popping 85% of non-commercial-scale biopharma manufacturing infrastructure—is the greater challenge in further growing industry acceptance of single-use technology Integrating Analytics And Automation In Cell Therapy Manufacturing Experts from last month’s Cell & Gene Live event discuss practical ways to utilize emerging technologies. More From Our Editors GUEST COLUMNISTS Wish SUS Cost Less? Survey Says Your Peers Do, Too BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area. A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster. Capacity, AI Driving Single-use Bioprocess Probe And Sensor Uptake Disposable probes and sensors offer advantages over their reusable counterparts, especially as industry moves toward flexible, scalable production models. Luxturna Maker Spark Therapeutics' Flexible Platform Approach The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss. The Small Biotech's Checklist For FIH Trials Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps. How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs.  Drug Product Formulation & Process Development: The Must-Have Skills At A Glance Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development. Tips For Deploying Advanced Modeling In Commercial Phase Bioprocessing In-silico tools are ubiquitous in development, but big hurdles prevent them from showing up meaningfully in commercial manufacturing. These tips could help clear them. More From Our Guest Columnists BIOPROCESSING WHITE PAPERS Establishing Commercial Manufacturing Services For ADCs Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023 The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines. Assessing Reliability, Confidence, And Batch Variation In PPQ Runs 6/29/2023 Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs. Optimizing Aliquoting For Robust Cell And Gene Therapy Processes 6/3/2024 Explore the challenges of liquid handling in cell and gene therapy processes as well as innovative solutions to simplify aliquoting in modern bioprocesses. Single-Use vs. Stainless Steel Debate In Biopharmaceutical Manufacturing 9/1/2023 Investigate the advantages and disadvantages of single-use technologies and stainless steel systems with a focus on performance, adaptability, and economics. Extractables And Leachables Testing 4/9/2024 Learn how to navigate the extractables and leachables regulatory landscape and implement best practices for leachables analysis in your pharmaceutical development process. More Bioprocessing White Papers BIOPROCESSING APP NOTES & CASE STUDIES High-Quality Serum to Improve Performance And Supply Stability Getting CMC Right For Emerging Technologies E. coli Fermentation Process Analysis With A Bioprocess Autosampler rAAV Production Using HEK293 Cell Line And Transfection Medium Recombinant Adeno-Associated Virus Type 5 Production Process More Bioprocessing App Notes & Case Studies Newsletter Signup Get the latest articles from Bioprocess Online delivered to your inbox. I agree to the Terms. I agree to the Privacy Statement. SIGN ME UP BIOPROCESS ONLINE CONTENT COLLECTIONS   This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions. More Content Collections FEATURED PRODUCTS AND SERVICES The Industrial DataOps Solution For Industry 4.0 High-Performance Filtration For Optimal Life Science Workflows Amorphous Stabilization MicroCNX® ULT Series Aseptic Micro-Connector For Cryogenic Freezing Applications Automated, Single-Use System For Clinical And Commercial LNP Production Automate Your Fill and Finish Process for Precision HCP Coverage Kit AAV cGMP Manufacturing Located In San Sebastian, Spain More From Featured Products ON-DEMAND WEBINARS Navigating Challenges During Formulation Development Formulation Considerations For The Development Of High Concentration Biopharmaceuticals Maximize Quality Assurance Through Rapid Sterility Testing Intensifying Downstream Bioprocessing With Continuous Technologies Innovations In Perfusion Bioprocessing More On-Demand Webinars INDUSTRY NEWS Next-Generation TFF Cassette, Vivaflow® SU, Delivers Intuitive, Effortless, And Sustainable Ultrafiltration To Research Scientists NEW: CGT Industry's First Aseptic Micro-Connector For Cryogenic Applications "How Can Drug Manufacturing Utilize Technology To Improve Efficiency And Reduce Waste?" Event Planned In South San Francisco For Sept 19 "Pharmaceutical Industry Practices And The Role Of Emerging Technologies" Event Announced For Sept 17 In Indianapolis CAI To Host Drug Manufacturing Event In Austin TX Sept 10 Nordson Corporation Completes Acquisition Of Atrion Corporation Bio X Cell Announces CEO Appointment Singota Solutions Announces -40 °C Pallet Storage Offering In EU Former Emergent BioSolutions Biopharma Equipment Auction Announced For September 12-13 CAI Announces "How Technology Can Transform Drug Manufacturing " Event In San Diego More Industry News NEWSLETTER ARCHIVE 09.13.24 -- The Importance Of Transparency In Fruitful Outsourcing Relationships 09.13.24 -- DSCSA Implementation Is Progressing, But More Complexity May Be Coming 09.12.24 -- Outsourcing Strategies To Maximize RNA-LNP Success 09.12.24 -- A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions 09.11.24 -- Modular Approach To AAV Manufacturing Platforms More Newsletters This website uses cookies to ensure you get the best experience on our website. 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