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X-WR-CALNAME:The BioCalendar
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DTSTART;TZID=America/Los_Angeles:20260908T160000
DTEND;TZID=America/Los_Angeles:20260908T170000
DTSTAMP:20260812T085719Z
CREATED:20260805T181903Z
LAST-MODIFIED:20260812T085719Z
UID:10946-1788883200-1788886800@thebiocalendar.com
SUMMARY:Beyond breakdowns: Building a culture of proactive maintenance
DESCRIPTION:Across biopharma operations\, reactive “run‑to‑failure” maintenance is one of the biggest hidden drivers of downtime\, deviations\, and escalating lifecycle cost. As the industry moves toward digital maturity\, organizations are shifting from calendar‑based activities to proactive\, engineering‑driven practices that eliminate root causes\, strengthen compliance\, and create the foundation for future predictive and prescriptive strategies. \nProactive maintenance focuses on precision\, consistency\, and early intervention—addressing the mechanical\, procedural\, and environmental factors that lead to recurring failures. This approach not only reduces unplanned downtime and costly emergency service but also supports audit readiness through clear documentation and alignment with Original Equipment Manufacturer (OEM) best practices. For most sites\, these fundamentals deliver the fastest\, highest‑ROI reliability gains long before advanced analytics or AI‑driven tools come into play. \nJoin our session to explore how proactive maintenance can significantly improve equipment uptime\, operational resilience\, and regulatory confidence while preparing your organization for the next stages of digital reliability. \nIn this session\, you will: \nUnderstand the maintenance maturity pyramid and how to intentionally progress through each level\nLearn how proactive\, hands‑on maintenance practices reduce failures and improve cost efficiency\nExplore how lifecycle management integrates with preventive\, proactive\, and predictive strategies\nGain practical tips for implementing proactive maintenance today—and preparing for a predictive or prescriptive culture in the future
URL:https://thebiocalendar.com/event/beyond-breakdowns-building-a-culture-of-proactive-maintenance/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/08/09-08-26-Cytiva-LinkedIn-1280x720-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260909T110000
DTEND;TZID=America/New_York:20260909T120000
DTSTAMP:20260812T085742Z
CREATED:20260810T191003Z
LAST-MODIFIED:20260812T085742Z
UID:11005-1788951600-1788955200@thebiocalendar.com
SUMMARY:How to Achieve Stable\, High-Output Stickpack Production
DESCRIPTION:The key to unlocking maximum OEE? Integrating dosing accuracy\, platen sealing\, magnetic shuttle transport\, and automated 100% in-line quality control into a unified workflow. \nJoin our virtual event\, “How to Achieve Stable\, High-Output Stickpack Production” with packaging expert René Schubert (Körber Pharma). \nWhy you can’t afford to miss this:\n– Discover how integrated stickpack & cartoning lines simplify operations.\n– Learn technology levers (platen sealing\, magnetic shuttle transport) that slash waste and boost uptime.\n– Future-proof your facility for regulatory compliance and sustainability goals.
URL:https://thebiocalendar.com/event/how-to-achieve-stable-high-output-stickpack-production/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260910T110000
DTEND;TZID=America/Los_Angeles:20260910T120000
DTSTAMP:20260812T085808Z
CREATED:20260805T181605Z
LAST-MODIFIED:20260812T085808Z
UID:10941-1789038000-1789041600@thebiocalendar.com
SUMMARY:Scaling Next-Gen MSC Therapies Without Scaling Risk
DESCRIPTION:Mesenchymal stromal cell (MSC) therapies are entering a pivotal stage of development. As more programs move toward late-stage clinical trials and commercialization\, developers must produce enough high-quality cells to meet growing demand while maintaining potency\, consistency\, and manufacturability. How can companies scale MSC production without compromising the biological properties that drive therapeutic efficacy? \nJoin Cell & Gene’s Chief Editor\, Erin Harris\, for this Cell & Gene Live discussion featuring Miguel Forte\, M.D.\, Ph.D.\, CEO of Kiji Therapeutics\, Silviu Itescu\, M.D.\, Founder\, CEO\, and Managing Director of Mesoblast\, and Edward Ahn\, Ph.D.\, CEO of MEDIPOST. Together\, these experts bring decades of experience developing\, manufacturing\, and commercializing MSC therapies. Their combined expertise spans early innovation\, scalable manufacturing\, and commercial execution. \nThe expert panel will discuss strategies for scaling MSC therapies while minimizing donor variability\, preserving potency\, improving process consistency\, and building commercially viable manufacturing platforms. They will also examine advances in cell sourcing\, process development\, quality systems\, and manufacturing strategy. Attendees will leave with practical insights into what developers should prioritize today to improve their products’ chances of clinical and commercial success. \nRegistration is free.
URL:https://thebiocalendar.com/event/scaling-next-gen-msc-therapies-without-scaling-risk/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260910T110000
DTEND;TZID=America/Los_Angeles:20260910T120000
DTSTAMP:20260817T231840Z
CREATED:20260813T125211Z
LAST-MODIFIED:20260817T231840Z
UID:11060-1789038000-1789041600@thebiocalendar.com
SUMMARY:Autonomous Impinging Jet Mixing for LNP Process Development
DESCRIPTION:Lipid nanoparticles (LNPs) are critical to the delivery of genetic medicines\, but developing scalable\, reproducible manufacturing processes remains complex and resource-intensive. Because LNP quality can be highly sensitive to formulation and processing conditions\, identifying the right parameters efficiently is essential. \nThis webinar will explore how impinging jet mixing\, automation\, inline analytics\, and data-driven optimization can accelerate LNP process development. Attendees will see how automated design of experiments\, dynamic process sweeps\, self-optimization\, and predictive modeling can help map process-property relationships and identify conditions that achieve target quality attributes.
URL:https://thebiocalendar.com/event/autonomous-impinging-jet-mixing-for-lnp-process-development/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260911T110000
DTEND;TZID=America/Los_Angeles:20260911T120000
DTSTAMP:20260812T085847Z
CREATED:20260805T182248Z
LAST-MODIFIED:20260812T085847Z
UID:10951-1789124400-1789128000@thebiocalendar.com
SUMMARY:De-Risking Cell Culture Media Scale-Up for Late-Stage Manufacturing
DESCRIPTION:Strategies for supply assurance\, QC readiness\, digital optimization\, and commercial bioprocessing success. \nThe translation of cell culture processes from laboratory-scale development to commercial manufacturing remains one of the most critical challenges in bioprocessing. While small-scale systems provide valuable insights into cell growth\, productivity\, and product quality\, scale-up introduces complex engineering and biological variables that can significantly impact process performance. Scale-up also comes with additional considerations that can greatly impact efficiency\, cost and speed-to-market. \nIn this webinar\, a panel of experienced professionals from Thermo Fisher Scientific will explore potential challenges encountered during cell culture media manufacturing scale-up\, options and solutions. A sample of topics will include: \nSupply assurance—approaches to help ensure transparent and uninterrupted global supply of your cell culture media\nBenefits of granular cell culture media formats\, including preparation time productivity and financial savings models\nManaging emerging QC considerations to meet new regulatory requirements\nHow digital tools are helping change how media formulations are designed and optimized\nCase study real-world examples of how Thermo Fisher has worked with customers to successfully navigate late-stage media manufacturing \nThis session includes a Q and A with our presenters immediately following the presentation.
URL:https://thebiocalendar.com/event/de-risking-cell-culture-media-scale-up-for-late-stage-manufacturing/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/08/09-11-26-Thermo-Reg-1920x250-0.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260914T110000
DTEND;TZID=America/Los_Angeles:20260914T120000
DTSTAMP:20260817T231855Z
CREATED:20260812T195344Z
LAST-MODIFIED:20260817T231855Z
UID:11053-1789383600-1789387200@thebiocalendar.com
SUMMARY:Driving Productivity Across the Antibody Manufacturing Workflow
DESCRIPTION:Join us for an exclusive webinar exploring practical strategies to improve therapeutic antibody manufacturing through integrated upstream and downstream process solutions. As therapeutic antibody titers continue to rise\, manufacturers face increasing pressure to remove harvest bottlenecks\, improve purification efficiency\, and maintain product quality while controlling manufacturing costs. Successfully integrating upstream and downstream operations has become essential for improving throughput and enabling scalable commercial manufacturing. \nIn this webinar\, Thermo Fisher Scientific experts will feature a case study highlighting innovative single-use harvest and clarification technologies\, along with practical approaches to downstream purification process optimization. \nDuring this webinar\, you will learn:\n~ How integrated upstream and downstream solutions can support therapeutic antibody process development and scale-up\n~ How Thermo Scientific™ DynaSpin™ Single-Use Centrifuge and Harvest RC™ Chromatographic Clarifier technologies can simplify harvest operations while maintaining product quality\n~ Case study data demonstrating scalable harvest clarification from development through manufacturing\, including process performance and economic modelling\n~ Practical downstream optimization strategies\, including Protein A capture optimization\, polishing simplification\, and flexible purification approaches \nWho should attend: \nBioprocess scientists and engineers\nUpstream and downstream process development teams\nManufacturing Science & Technology (MSAT) professionals\nProcess development managers\nTechnical operations and manufacturing professionals\nCDMO\, biotech\, and biopharmaceutical organizations
URL:https://thebiocalendar.com/event/driving-productivity-across-the-antibody-manufacturing-workflow/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/08/09-14-26-Thermo-LinkedIn-1280x720-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260914T110000
DTEND;TZID=America/Los_Angeles:20260914T120000
DTSTAMP:20260831T214434Z
CREATED:20260831T214434Z
LAST-MODIFIED:20260831T214434Z
UID:11189-1789383600-1789387200@thebiocalendar.com
SUMMARY:Future-Proofing Your USP  Strategy: Preparing for the Next Generation of Biological Reactivity Testing
DESCRIPTION:As the December 1\, 2026 release of the revised USP <87>\, Biological Reactivity Tests\, In Vitro\, approaches\, pharmaceutical and medical device manufacturers should begin evaluating how these changes may impact their material qualification\, biological evaluation\, and compliance strategies. While the final chapter has not yet been published\, the proposed direction reflects a broader industry shift toward modern\, science-based in vitro testing approaches\, quantitative data generation\, and risk-based assessment methodologies. \nJoin Pace® Life Sciences for an informative webinar exploring what organizations can expect from the upcoming revisions\, how evolving regulatory expectations may influence testing programs\, and practical steps to prepare before implementation. Our scientific experts will discuss anticipated changes\, the potential impact on qualification and validation activities\, and how proactive planning can help ensure a smooth transition while maintaining compliance and operational efficiency. \nKey learning objectives: \n\nUnderstand the anticipated revisions to USP <87> and how they reflect the industry’s shift toward modern\, science-based in vitro biological reactivity testing\nEvaluate the potential impact on your organization by exploring how the revised chapter may affect material qualification\, biological evaluation strategies\, validation activities\, and regulatory documentation\nLearn practical steps to prepare for implementation by developing a proactive strategy for testing readiness\, laboratory planning\, and compliance before the revised chapter is released
URL:https://thebiocalendar.com/event/future-proofing-your-usp-strategy-preparing-for-the-next-generation-of-biological-reactivity-testing/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260915T110000
DTEND;TZID=America/Los_Angeles:20260915T120000
DTSTAMP:20260812T085901Z
CREATED:20260810T175809Z
LAST-MODIFIED:20260812T085901Z
UID:10992-1789470000-1789473600@thebiocalendar.com
SUMMARY:Crossing The Valley Of Death: New Funding Options For Preclinical And Early-Stage Drug Development
DESCRIPTION:A risk-averse investment climate has made it more difficult for startups to find the funding needed to bring novel treatments into the clinic. However\, alternative funding sources\, investment models\, and nontraditional investors are stepping in to fill the void. Our panel of experts will identify and discuss new funding opportunities and strategies for companies at preclinical and the early stages of clinical development.
URL:https://thebiocalendar.com/event/crossing-the-valley-of-death-new-funding-options-for-preclinical-and-early-stage-drug-development/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/08/09-15-26-LSL-LinkedIn-1280x720-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260916T100000
DTEND;TZID=America/Los_Angeles:20260916T110000
DTSTAMP:20260812T085919Z
CREATED:20260806T174539Z
LAST-MODIFIED:20260812T085919Z
UID:10965-1789552800-1789556400@thebiocalendar.com
SUMMARY:Virtual Pharma Expo: Oral Solid Dose Manufacturing & Packaging
DESCRIPTION:Virtual Pharma Expo – a themed event featuring presentations and demonstrations by leading experts from pharmaceutical equipment providers for oral solid dose manufacturing and packaging.
URL:https://thebiocalendar.com/event/virtual-pharma-expo-oral-solid-dose-manufacturing-packaging/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260917T110000
DTEND;TZID=America/New_York:20260917T120000
DTSTAMP:20260817T231914Z
CREATED:20260813T173402Z
LAST-MODIFIED:20260817T231914Z
UID:11065-1789642800-1789646400@thebiocalendar.com
SUMMARY:Injected And Connected? Digital Strategies For Raising Delivery IQ
DESCRIPTION:Innovations in self-administered and wearable drug delivery technologies promise convenience but bring questions about how to effectively monitor and manage patient safety\, adherence\, dosing accuracy\, and\, ultimately\, medical outcomes. In this live online session\, expert panelists will discuss approaches to leveraging the power of digital tools to provide feedback loops and administrative controls. From both strategic and practical perspectives\, the panel will address biopharma product development considerations. This is a free event; click to learn more.
URL:https://thebiocalendar.com/event/injected-and-connected-digital-strategies-for-raising-delivery-iq/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260918T110000
DTEND;TZID=America/Los_Angeles:20260918T120000
DTSTAMP:20260812T085937Z
CREATED:20260807T180605Z
LAST-MODIFIED:20260812T085937Z
UID:10971-1789729200-1789732800@thebiocalendar.com
SUMMARY:Making The Jump To GMP: Material Decisions For Clinical Manufacturing
DESCRIPTION:Transitioning development processes into GMP manufacturing can come with a fair share of growing pains. Development teams need to contend with things like sourcing and validating new materials\, ensuring regulatory compliance\, performing risk assessments\, and evaluating facility fit. Unexpected challenges in any aspect of this transition can be costly and delay a product’s time to enter the clinic. \nJoin Bioprocess Online’s Tyler Menichiello for an interactive panel discussion on phase-appropriate CMC decisions and material selection for GMP readiness. This conversation will feature Wei Lu\, Ph.D.\, a senior staff bioprocess engineer at Takeda; Tiffany Rau\, Ph.D.\, owner and principal consultant at Bio Pharma Technical Consulting; and Mary Rodley\, an independent consultant with Medius Consulting\, LLC. These experts will focus on the challenge of sourcing and implementing GMP-grade materials and equipment in a process for the first time. \nWhether you’re in the throes of transitioning into clinical manufacturing or are preparing to do so\, this event will identify the key considerations and choices that matter the most.
URL:https://thebiocalendar.com/event/making-the-jump-to-gmp-material-decisions-for-clinical-manufacturing/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://thebiocalendar.com/wp-content/uploads/2026/08/26_09-BPOL-LinkedIn-1280x720-1.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260921T110000
DTEND;TZID=America/Los_Angeles:20260921T120000
DTSTAMP:20260831T214603Z
CREATED:20260831T214603Z
LAST-MODIFIED:20260831T214603Z
UID:11193-1789988400-1789992000@thebiocalendar.com
SUMMARY:Beyond the Starting Material: Building a Path to GMP Manufacturing Success
DESCRIPTION:For cell therapy developers\, manufacturing success starts well before a process enters a GMP cleanroom. Decisions around donor and material sourcing\, collection strategy\, starting material specifications\, process development\, and analytical strategy can directly influence process consistency\, technology transfer\, and manufacturing readiness. \nJoin technical experts from New York Blood Center Enterprises’ Comprehensive Cell Solutions (CCS) team for a practical discussion on connecting cellular starting materials with downstream process development and GMP manufacturing. Drawing on real-world experience across sourcing\, collections\, process and analytical development\, technology transfer\, and clinical manufacturing\, the panel will highlight key considerations and common challenges that arise as programs move from early development toward the clinic through commercialization. \nThe discussion will explore how teams can better align starting material requirements with the manufacturing process\, establish appropriate controls and specifications\, prepare processes for successful technology transfer\, and build a more reliable path into GMP manufacturing. Attendees will leave with practical considerations for reducing variability\, anticipating manufacturing challenges\, and making development decisions with later-stage requirements in mind. \nKey Learning Objectives \n\nUnderstand the role of starting material in process performance and how donor criteria\, collection strategy\, material attributes\, and variability should be considered during development\nIdentify key considerations when moving a process into GMP manufacturing\, including process and analytical readiness\, technology transfer\, facility fit\, and operational execution\nLearn how early development decisions can support later-stage manufacturing\, helping teams anticipate risks\, improve process robustness\, and prepare for clinical and commercial requirements
URL:https://thebiocalendar.com/event/beyond-the-starting-material-building-a-path-to-gmp-manufacturing-success/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
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