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DTSTART;TZID=America/Los_Angeles:20260728T110000
DTEND;TZID=America/Los_Angeles:20260728T120000
DTSTAMP:20260714T200041Z
CREATED:20260701T172846Z
LAST-MODIFIED:20260714T200041Z
UID:10717-1785236400-1785240000@thebiocalendar.com
SUMMARY:Rewriting the Code: Advances and Challenges in Pediatric Gene Therapy
DESCRIPTION:Pediatric gene therapy is rapidly reshaping what is possible for children born with rare genetic diseases. Join Dr. Rachel Abu Taleb\, Medical Director\, Medical Affairs at Veristat\, for a look at the platforms driving clinical progress\, including AAV vectors\, lentiviral approaches\, and CRISPR-based gene editing. \nThrough examples such as Luxturna\, Zolgensma\, Casgevy\, and Lyfgenia\, this webinar will explore what recent approvals have taught the field across retinal\, neuromuscular\, and hematologic diseases. Dr. Abu Taleb will also discuss the safety\, regulatory\, long-term follow-up\, newborn screening\, and access challenges that continue to shape pediatric gene therapy development and delivery.
URL:https://thebiocalendar.com/event/rewriting-the-code-advances-and-challenges-in-pediatric-gene-therapy/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/07/07-28-26-Veristat-eBlast-700x200-2.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260724T110000
DTEND;TZID=America/Los_Angeles:20260724T120000
DTSTAMP:20260630T200730Z
CREATED:20260630T174022Z
LAST-MODIFIED:20260630T200730Z
UID:10698-1784890800-1784894400@thebiocalendar.com
SUMMARY:The Hidden Cost of CRO Change Orders and How Sponsors Can Best Manage Them
DESCRIPTION:CRO change orders can quickly become difficult to manage once a study is underway\, especially when budget revisions\, approvals\, comments\, and financial projections are spread across emails\, spreadsheets\, and disconnected systems. Join Clin.AI Founder and President Kalyan Obalampalli and clinical operations executive Leticia Tarilonte for a discussion on how sponsors can improve visibility into change order status\, track projections versus actual spend\, streamline approvals\, and maintain a complete audit trail throughout study execution. \nThis webinar will explore practical approaches for managing CRO change orders more efficiently\, reducing budget surprises\, and improving collaboration with vendors. \nRegister for the webinar on July 24\, 2026\, at 12:00 PM ET.
URL:https://thebiocalendar.com/event/the-hidden-cost-of-cro-change-orders-and-how-sponsors-can-best-manage-them/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260723T110000
DTEND;TZID=America/Los_Angeles:20260723T120000
DTSTAMP:20260630T200748Z
CREATED:20260630T141331Z
LAST-MODIFIED:20260630T200748Z
UID:10678-1784804400-1784808000@thebiocalendar.com
SUMMARY:Enhancing AAV Manufacturing Yield Through a Promoter-Optimized Mini-Helper Plasmid
DESCRIPTION:Discover how a simple redesign of the AAV helper plasmid could make gene therapy manufacturing more efficient and cost-effective. \nIn this webinar\, Samsung Biologics shares how its promoter-optimized mini-helper plasmid delivers up to a 6.5-fold increase in AAV yield\, reduces DNA synthesis costs\, and maintains high particle quality from lab scale to bioreactor production. \nYou’ll gain practical insights into the platform’s design\, transfection optimization\, and its potential to enable next-generation AAV manufacturing strategies.
URL:https://thebiocalendar.com/event/enhancing-aav-manufacturing-yield-through-a-promoter-optimized-mini-helper-plasmid/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/06/07-23-26-Samsung-eblast-700x200-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260722T110000
DTEND;TZID=America/Los_Angeles:20260722T120000
DTSTAMP:20260714T200021Z
CREATED:20260630T203132Z
LAST-MODIFIED:20260714T200021Z
UID:10712-1784718000-1784721600@thebiocalendar.com
SUMMARY:Navigating AI Compliance in Life Sciences: FDA Policy Insights for AI Governance
DESCRIPTION:Life science organizations face critical questions about how to implement these tools while maintaining FDA compliance. Join us for a conversation on artificial intelligence in life sciences that bridges regulatory guidance with practical application\, giving quality professionals the insights they need to confidently adopt AI in their operations.
URL:https://thebiocalendar.com/event/navigating-ai-compliance-in-life-sciences-fda-policy-insights-for-ai-governance/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/06/07-22-26-MasterControl-Reg-1920x250-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260722T100000
DTEND;TZID=America/Los_Angeles:20260722T120000
DTSTAMP:20260618T235449Z
CREATED:20260611T145828Z
LAST-MODIFIED:20260618T235449Z
UID:10578-1784714400-1784721600@thebiocalendar.com
SUMMARY:Smart Sourcing: Patient Recruitment & Retention Showcase
DESCRIPTION:This 2-hour virtual showcase gives clinical teams a faster\, easier way to evaluate patient recruitment and retention partners. Attendees will hear short capability presentations\, compare providers side by side\, and ask questions directly during live Q&A. \nAttendees will gain: \n• A clearer view of available recruitment and engagement solutions\n• A more efficient way to compare potential partners without conference travel\n• Practical ideas to support enrollment timelines\, diversity goals\, and site experience\n• Direct access to provider insights during live Q&A\n• A stronger shortlist of partners to consider for upcoming studies\n• Takeaways to help reduce patient drop-off and improve recruitment planning
URL:https://thebiocalendar.com/event/smart-sourcing-patient-recruitment-retention-showcase/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/06/07-2026-CLSE-700x200-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260721T110000
DTEND;TZID=America/Los_Angeles:20260721T120000
DTSTAMP:20260618T235502Z
CREATED:20260615T145655Z
LAST-MODIFIED:20260618T235502Z
UID:10616-1784631600-1784635200@thebiocalendar.com
SUMMARY:When High-Stakes ADC Decisions Can't Wait for More Material or Better Data
DESCRIPTION:Early ADC development often requires critical decisions to be made with limited data and scarce material. In this webinar\, discover a streamlined analytical approach that enables accurate measurement of antibody-drug conjugate (ADC) concentration and drug-to-antibody ratio (DAR) without resource-intensive calibration assays. \nAttendees will learn how combining LC-MRM with a single UV280 measurement can generate reliable concentration data\, establish reusable linker-payload extinction coefficients\, and accelerate candidate evaluation. The session will provide practical insights into improving developability assessments and making more confident ADC decisions earlier in the development process.
URL:https://thebiocalendar.com/event/when-high-stakes-adc-decisions-cant-wait-for-more-material-or-better-data/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260716T120000
DTEND;TZID=America/Los_Angeles:20260716T130000
DTSTAMP:20260709T105826Z
CREATED:20260709T105826Z
LAST-MODIFIED:20260709T105826Z
UID:10756-1784203200-1784206800@thebiocalendar.com
SUMMARY:An Agentic AI Approach to Predicting Immunotherapy Response
DESCRIPTION:Immune checkpoint inhibitors have transformed cancer care\, yet only about 1 in 5 patients respond to PD-1 blockade. Predicting who will respond remains one of oncology’s biggest unsolved challenges. \nIn this webinar\, scientists from Mithrl and Elephas will share how combining functional tumor profiling with agentic AI can reduce that uncertainty\, integrating real-time cytokine data from live tumor biopsies with large-scale genomic datasets to reveal the immune signatures that drive response. Attendees will get a firsthand look at how this approach was applied across 131 human tumor specimens and what it uncovered. \nKey topics include: \n\nWhat these findings mean for biomarker strategy\, patient selection\, and immunotherapy drug development\nHow Elephas’ elive platform captures real-time tumor responses to checkpoint inhibitors using live tumor fragments from patient biopsies\nHow Mithrl’s AI Scientific Decision Engine integrates multiple data types to generate biological insights\, without the manual data wrangling or pipeline engineering such analyses typically require\nThe distinct immune profiles and cytokine signatures identified across patient subgroups\, validated against public genomic datasets
URL:https://thebiocalendar.com/event/an-agentic-ai-approach-to-predicting-immunotherapy-response/
LOCATION:Online webinar
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260716T110000
DTEND;TZID=America/Los_Angeles:20260716T120000
DTSTAMP:20260618T235534Z
CREATED:20260612T113815Z
LAST-MODIFIED:20260618T235534Z
UID:10594-1784199600-1784203200@thebiocalendar.com
SUMMARY:The Site AI Playbook: Vendor Tools\, Homegrown Solutions & What's Working
DESCRIPTION:This webinar gives clinical research sites a practical look at how AI is being used today across source documentation\, regulatory compliance\, finance\, eSource\, and other site operations. CRIO’s Mike Wenger will join a panel of clinical site operators to discuss what’s working\, what’s overhyped\, and how sites can evaluate AI opportunities with more confidence. \nAttendees will walk away with the ability to:\n• Decide when to build\, configure\, or buy AI solutions\n• Identify high-impact AI use cases for site operations\n• Evaluate vendor claims and spot potential red flags\n• Apply real examples from eSource\, document review\, compliance\, and financial workflows\n• Use AI to improve speed\, quality\, and compliance across clinical trials
URL:https://thebiocalendar.com/event/the-site-ai-playbook-vendor-tools-homegrown-solutions-whats-working/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260714T110000
DTEND;TZID=America/Los_Angeles:20260714T120000
DTSTAMP:20260624T203130Z
CREATED:20260623T180356Z
LAST-MODIFIED:20260624T203130Z
UID:10640-1784026800-1784030400@thebiocalendar.com
SUMMARY:The Risk And Reality Of 3D Printed Parts In Single-Use Workflows
DESCRIPTION:The trend toward 3D printing in process development is driven by early-stage benefit: engineers can create custom equipment for scale-up and scale-down initiatives and mitigation of process integration challenges. When sourcing unique or bespoke single-use parts is the bottleneck\, 3D printing offers a rapid way to keep development moving. However\, it comes with inherent risks. \n3D printing puts validation on the shoulders of the sponsor company. Issues like extractables and leachables\, integrity\, and regulatory scrutiny warrant serious consideration for anyone working toward GMP compliance. Building processes using components that may not exist\, now or ever\, outside your process lab could upend a pipeline before Phase 2. \nBioprocess Online Live’s expert panel\, including James Dean Vogel of The BioProcess Institute\, Vikash Kumar at Merck\, and Robert Dream\, an independent consultant and former biopharmaceutical executive\, will explore where and why 3D printing is being incorporated into process development workflows. They’ll also dig into some of the show-stopping hazards of “DIYing” your way to GMP.
URL:https://thebiocalendar.com/event/the-risk-and-reality-of-3d-printed-parts-in-single-use-workflows/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260710T110000
DTEND;TZID=America/Los_Angeles:20260710T120000
DTSTAMP:20260618T235602Z
CREATED:20260615T145422Z
LAST-MODIFIED:20260618T235602Z
UID:10612-1783681200-1783684800@thebiocalendar.com
SUMMARY:Modular vs Flexible Aseptic Filling Lines: Impacts on Speed\, Changeovers\, and Scale
DESCRIPTION:As biologics\, complex injectables\, and stricter regulatory requirements reshape sterile manufacturing\, facility design has become a critical factor in operational success. In this webinar\, learn how purpose-built modular aseptic filling facilities can improve contamination control\, manufacturing flexibility\, and scalability compared with retrofitted legacy sites. \nUsing real-world insights from Kindeva’s Bridgeton facility\, attendees will explore how modern facility design—from modular filling suites and independent environmental controls to warehousing\, cold storage\, and utilities—can accelerate operations\, support future growth\, and create a more resilient aseptic manufacturing ecosystem.
URL:https://thebiocalendar.com/event/modular-vs-flexible-aseptic-filling-lines-impacts-on-speed-changeovers-and-scale/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260709T110000
DTEND;TZID=America/Los_Angeles:20260709T120000
DTSTAMP:20260618T235644Z
CREATED:20260615T143351Z
LAST-MODIFIED:20260618T235644Z
UID:10598-1783594800-1783598400@thebiocalendar.com
SUMMARY:The mRNA Therapeutics Regulatory Paradigm: A Closer Look
DESCRIPTION:In some ways\, it has been a quiet(er) year on the regulatory front for mRNA; there have been no mRNA-specific guidances released since the MHRA personalized cancer immunotherapy guidance and the EMA’s mRNA vaccine quality guidance — both of which were released in the winter of 2025. However\, there has been a flurry of activity at the FDA\, including new leadership appointments and the release of several guidances impacting the advanced therapies/personalized medicines sector. \nIn this discussion\, Advancing RNA Live Chief Editor Anna Rose Welch will dig into current events and recent guidance to identify the impacts these developments will have on the mRNA sector overall.
URL:https://thebiocalendar.com/event/the-mrna-therapeutics-regulatory-paradigm-a-closer-look/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260707T110000
DTEND;TZID=America/Los_Angeles:20260707T120000
DTSTAMP:20260624T203118Z
CREATED:20260623T180209Z
LAST-MODIFIED:20260624T203118Z
UID:10636-1783422000-1783425600@thebiocalendar.com
SUMMARY:Solving Vector Yield Challenges in In Vivo CGT
DESCRIPTION:What does it take to turn breakthrough biology into successful in vivo therapies? \nAs innovations in synthetic biology\, RNA editing\, and gene therapy continue to accelerate\, vector design and manufacturing remain the critical link between scientific discovery and patient impact. \nJoin Chief Editor Erin Harris for a special Cell & Gene Live discussion with Robert Bell\, Ph.D.\, CSO at Ascidian Therapeutics\, and Karen Kozarsky\, Ph.D.\, Founder of Vector BioPartners. Together\, they’ll explore how capsid engineering affects transduction efficiency\, the tradeoffs between tissue specificity and manufacturability\, and what manufacturing teams need to know about real-world in vivo performance. \nDon’t miss this expert conversation on the challenges and opportunities shaping the future of in vivo cell and gene therapies. \nRegistration is free.
URL:https://thebiocalendar.com/event/solving-vector-yield-challenges-in-in-vivo-cgt/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260701T130000
DTEND;TZID=America/Los_Angeles:20260701T140000
DTSTAMP:20260618T235854Z
CREATED:20260528T173004Z
LAST-MODIFIED:20260618T235854Z
UID:10545-1782910800-1782914400@thebiocalendar.com
SUMMARY:Reducing Particulate-Related Batch Risk in Bioprocessing: Moving from Detection to Prevention
DESCRIPTION:Rising regulatory expectations and increased scrutiny around particulate contamination are reshaping how risk is managed in bioprocessing. Particulate issues are often identified late in the process\, leading to operational disruption\, rework\, and increased validation burden. \nThis webinar explores how organizations can shift from reactive responses to proactive containment strategies. Using aggregated industry insights and representative case patterns\, we’ll examine where issues occur\, their operational impact\, and how low and ultra-low particulate container solutions can help reduce risk earlier and improve process reliability.
URL:https://thebiocalendar.com/event/reducing-particulate-related-batch-risk-in-bioprocessing-moving-from-detection-to-prevention/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260701T110000
DTEND;TZID=America/Los_Angeles:20260701T120000
DTSTAMP:20260619T000522Z
CREATED:20260605T200441Z
LAST-MODIFIED:20260619T000522Z
UID:10574-1782903600-1782907200@thebiocalendar.com
SUMMARY:A Closer Look at How Single Use Consumables Drive Cost per Therapy
DESCRIPTION:The discussion will examine key manufacturing challenges and highlight where consumables add value\, where they introduce unnecessary complexity\, and how early upstream and downstream decisions impact long-term cost\, scalability\, and risk. Attendees will leave with key points to consider on how to approach consumables as a strategic part of manufacturing\, rather than a line-item cost.
URL:https://thebiocalendar.com/event/a-closer-look-at-how-single-use-consumables-drive-cost-per-therapy-2/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260630T120000
DTEND;TZID=America/Los_Angeles:20260630T130000
DTSTAMP:20260618T235845Z
CREATED:20260528T122037Z
LAST-MODIFIED:20260618T235845Z
UID:10540-1782820800-1782824400@thebiocalendar.com
SUMMARY:Residual DNA testing across biotherapeutics: dPCR workflows and a CDMO perspective
DESCRIPTION:Residual host cell DNA (residual DNA) is a critical quality attribute across biologics\, vaccines and advanced therapy modalities\, requiring sensitive and reproducible quantification to support process development\, in-process control and lot release. However\, traditional workflows can introduce variability and delay release timelines due to reliance on standard curves\, multiple manual steps and method complexity. \nIn this webinar\, we will outline digital PCR (dPCR) workflows and performance for residual DNA analysis across a range of expression systems\, including Vero\, Sf9/Baculovirus\, Pichia pastoris\, mouse\, HEK293\, CHO and E. coli. We will discuss how a standardized dPCR approach can simplify method deployment across diverse programs. \nKBI Biopharma will share real-life perspectives on implementing dPCR-based residual DNA workflows for CHO- and E. coli-derived programs\, including considerations for sample preparation and data interpretation. The session will also explore how extraction-free dPCR workflows can streamline in-process monitoring and lot release testing\, enabling faster decision-making and improved manufacturing efficiency. The webinar will conclude with practical guidance on assay selection and integration of residual DNA testing into development and manufacturing workflows. \nLearning objectives:\n– Understand dPCR-based residual DNA workflows and performance across multiple expression systems\n– Evaluate how dPCR can improve workflow efficiency and data quality\, including accuracy\, linearity\, and reduced turnaround time\n– Learn from a CDMO case study on implementing residual DNA testing\, including comparison to qPCR and the impact of extraction-free workflows on in-process monitoring and lot release
URL:https://thebiocalendar.com/event/residual-dna-testing-across-biotherapeutics-dpcr-workflows-and-a-cdmo-perspective/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-30-26-Qiagen-Reg-1920x250-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260630T110000
DTEND;TZID=America/Los_Angeles:20260630T120000
DTSTAMP:20260618T235913Z
CREATED:20260615T145041Z
LAST-MODIFIED:20260618T235913Z
UID:10608-1782817200-1782820800@thebiocalendar.com
SUMMARY:Breaking the Titer Ceiling: Smarter Media Design for Higher Productivity
DESCRIPTION:Discover how innovative media design strategies can help overcome productivity limitations in bioprocessing and drive higher titers without sacrificing product quality. In this webinar\, experts will share a data-driven\, bottom-up approach to media development using Design of Experiments (DOE) to identify the nutrients that have the greatest impact on cell culture performance. Learn how optimized basal and feed formulations can improve culture robustness\, alleviate metabolic bottlenecks\, and enhance productivity while maintaining critical quality attributes and process consistency.
URL:https://thebiocalendar.com/event/breaking-the-titer-ceiling-smarter-media-design-for-higher-productivity/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260630T110000
DTEND;TZID=America/Los_Angeles:20260630T120000
DTSTAMP:20260619T000052Z
CREATED:20260529T135221Z
LAST-MODIFIED:20260619T000052Z
UID:10553-1782817200-1782820800@thebiocalendar.com
SUMMARY:The Evolution and Future of Targeted Protein Degradation Chemistry
DESCRIPTION:Once a fringe idea in chemical biology\, targeted protein degradation (TPD) has become one of the most watched strategies in drug discovery. TPD has created new therapeutic opportunities for previously undruggable protein targets. Leading experts will discuss the design\, challenges\, and clinical promise of PROTACs in overcoming limitations of traditional small molecules. \nEver wonder: \nHow have PROTACS\, molecular glues\, and linker chemistries and their related research and development evolved over the past 20 years? \nHow we decide on the right modality and MoA? \nWhich discovery technologies are available to us? \nHow do they translate from animals to humans? \nHow are companies and academic groups approaching safety assessment for degraders\, particularly with respect to off‑target effects\, tissue specificity\, and long‑term protein knockdown? \nJoin us to get some answers directly from field experts.
URL:https://thebiocalendar.com/event/the-evolution-and-future-of-targeted-protein-degradation-chemistry/
LOCATION:Online webinar
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260625T110000
DTEND;TZID=America/Los_Angeles:20260625T120000
DTSTAMP:20260619T000138Z
CREATED:20260602T165807Z
LAST-MODIFIED:20260619T000138Z
UID:10567-1782385200-1782388800@thebiocalendar.com
SUMMARY:From AI Hype to Oversight Confidence: Accelerating Clinical Data Review Without Losing Control
DESCRIPTION:In this webinar\, Revvity Signals will explore how Signals Clinical applies governed\, fit-for-purpose AI within clinical data review workflows. The discussion will focus on practical ways to accelerate review while keeping clinical experts in control.
URL:https://thebiocalendar.com/event/from-ai-hype-to-oversight-confidence-accelerating-clinical-data-review-without-losing-control/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260625T110000
DTEND;TZID=America/Los_Angeles:20260625T120000
DTSTAMP:20260526T212741Z
CREATED:20260526T130939Z
LAST-MODIFIED:20260526T212741Z
UID:10516-1782385200-1782388800@thebiocalendar.com
SUMMARY:False Rejects Aren’t Inevitable: How to Reduce Waste and Improve Line Efficiency
DESCRIPTION:False rejects are more than a nuisance—they create unnecessary waste\, disrupt production efficiency\, and erode confidence in inspection systems. \nIn this webinar\, we will explore the top 10 causes of false rejects across system setup\, environmental conditions\, and product and operational variability. We will also demonstrate why false rejects are not inevitable\, but instead indicators of correctable issues. \nAttendees will gain insight into how false rejects may affect yield\, throughput\, compliance\, and brand reputation. We’ll also explore a range of practical considerations that can help minimize false rejects\, including system setup\, environmental conditions\, and day-to-day operational practices. \nThe webinar will conclude with a simple\, actionable checklist to help teams drive consistent\, reliable performance on the production line. \nKey Learning Objectives: \nIdentify the most common causes of false rejects and their impact on efficiency\, quality\, and compliance\nApply practical strategies to stabilize systems\, control environmental factors\, and reduce variability\nImplement a structured approach and checklist to systematically reduce false rejects and improve line performance
URL:https://thebiocalendar.com/event/false-rejects-arent-inevitable-how-to-reduce-waste-and-improve-line-efficiency/
LOCATION:Online webinar
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260625T100000
DTEND;TZID=America/Los_Angeles:20260625T140000
DTSTAMP:20260522T081737Z
CREATED:20260511T130147Z
LAST-MODIFIED:20260522T081737Z
UID:10413-1782381600-1782396000@thebiocalendar.com
SUMMARY:Bio-Expo Live: Bioprocess Quality\, Data\, & Analytical Solutions
DESCRIPTION:Bioprocess Online’s Bio-Expo Live is back with its series of live virtual events designed to empower biopharma professionals. Through these sessions\, attendees will have the chance to explore the newest equipment and solutions offered by our presenters\, aimed at addressing the current challenges within the drug development process. This interactive online platform ensures convenience and accessibility\, fostering an environment of learning and innovation for all participants. \nThe attendees of the Data\, Quality\, & Analytical session will have the chance to explore the latest equipment and solutions offered by our presenting suppliers essential to biopharmaceutical development and manufacturing. \nWhat can you expect? Short\, digital presentations with live interaction. You will have the opportunity to ask questions to better understand if they can meet your needs – all from the convenience of your computer! \nPlease note that this event is for biopharma companies or contract manufacturers seeking available quality\, data\, and/or analytical products/solutions to help them overcome their manufacturing challenges.
URL:https://thebiocalendar.com/event/bio-expo-live-bioprocess-quality-data-analytical-solutions-3/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-2026-BEL-1280x720-BQDA-scaled.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260624T110000
DTEND;TZID=America/Los_Angeles:20260624T120000
DTSTAMP:20260619T000202Z
CREATED:20260615T144808Z
LAST-MODIFIED:20260619T000202Z
UID:10604-1782298800-1782302400@thebiocalendar.com
SUMMARY:Building Scalable Non-Viral Gene-Edited Cell Therapy Processes
DESCRIPTION:Join this webinar to learn how leading cell therapy developers are tackling one of the field’s biggest challenges: scaling non-viral gene-edited cell therapies from research to manufacturing. Through real-world data in T\, NK\, and CD34+ cells\, experts will demonstrate how electroporation can enable efficient CRISPR knock-out\, knock-in\, and transposon-based editing while preserving critical cell quality attributes. You’ll gain practical insights into optimizing gene delivery\, improving process consistency\, and building scalable\, GMP-ready workflows that support successful clinical and commercial development.
URL:https://thebiocalendar.com/event/building-scalable-non-viral-gene-edited-cell-therapy-processes/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/06/06-24-26-Lonza-eBlast-700x200-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260624T110000
DTEND;TZID=America/Los_Angeles:20260624T120000
DTSTAMP:20260619T000220Z
CREATED:20260528T121712Z
LAST-MODIFIED:20260619T000220Z
UID:10532-1782298800-1782302400@thebiocalendar.com
SUMMARY:Global Regulatory Compliance for Aseptic Barrier Systems
DESCRIPTION:As sterile pharmaceutical manufacturing evolves\, isolators and Restricted Access Barrier Systems (RABS) have become central to contamination control strategies across global markets. Yet regulatory expectations from the FDA\, EU GMP Annex 1\, PIC/S\, and WHO differ in meaningful ways\, from legal enforceability to technical prescriptiveness\, creating compliance complexity for manufacturers supplying multiple markets. \nThis webinar provides a structured comparison of the four major regulatory frameworks governing aseptic barrier systems\, examining where they converge on scientific fundamentals and where they diverge in documentation requirements\, monitoring expectations\, and treatment of advanced technologies. Special focus will be given to the 2022 revision of EU GMP Annex 1 and its harmonized adoption across PIC/S and WHO. \nAttendees will leave with a clearer understanding of how to design and qualify barrier systems that satisfy both the principle-based flexibility of the FDA and the structured minimum standards of the EU/PIC/S/WHO model\, supporting a robust\, globally acceptable contamination control strategy. \nKEY LEARNING OBJECTIVES \n– Understand how FDA\, EU GMP Annex 1\, PIC/S\, and WHO align and differ in their requirements for isolators\, RABS\, and contamination control strategy documentation\n– Identify the practical compliance implications of regulatory divergence for manufacturers operating across multiple jurisdictions\n– Apply a risk-based framework for barrier system design\, decontamination validation\, and environmental monitoring that satisfies global inspection expectations
URL:https://thebiocalendar.com/event/global-regulatory-compliance-for-aseptic-barrier-systems/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-24-26-Esco-eBlast-700x200-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260624T100000
DTEND;TZID=America/Los_Angeles:20260624T140000
DTSTAMP:20260522T081810Z
CREATED:20260511T125831Z
LAST-MODIFIED:20260522T081810Z
UID:10409-1782295200-1782309600@thebiocalendar.com
SUMMARY:Bio-Expo Live: Downstream Bioprocessing
DESCRIPTION:Bioprocess Online’s Bio-Expo Live is back with its series of live virtual events designed to empower biopharma professionals. Through these sessions\, attendees will have the chance to explore the newest equipment and solutions offered by our presenters\, aimed at addressing the current challenges within the drug development process. This interactive online platform ensures convenience and accessibility\, fostering an environment of learning and innovation for all participants. \nThe attendees of the Downstream Manufacturing session will have the chance to explore the newest equipment and solutions offered by our presenting suppliers essential to Therapeutic areas from ADCs to Vaccines. \nWhat can you expect? Short\, digital presentations with live interaction. You will have the opportunity to ask questions to better understand if they can meet your needs – all from the convenience of your computer! \nPlease note that this event is for biopharma companies or contract manufacturers seeking available products/solutions to help them overcome downstream manufacturing challenges.
URL:https://thebiocalendar.com/event/bio-expo-live-downstream-bioprocessing-3/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-2026-BEL-1280x720-downstream-scaled.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260623T130000
DTEND;TZID=America/Los_Angeles:20260623T140000
DTSTAMP:20260619T000308Z
CREATED:20260526T130313Z
LAST-MODIFIED:20260619T000308Z
UID:10508-1782219600-1782223200@thebiocalendar.com
SUMMARY:Automating cell therapy manufacturing without redesigning established workflows
DESCRIPTION:As cell therapy programs transition into clinical development\, manufacturing teams face increasing pressure to automate workflows while preserving biological performance and hard-earned process knowledge. Many teams hesitate to introduce automation due to concerns around forced process redesign\, loss of flexibility\, or risks to clinical timelines. \nIn this webinar\, Cytiva specialists will demonstrate how the Sefia™ cell therapy manufacturing platform enables closed\, automated processing without requiring changes to existing media\, reagents\, or core process logic. Using real workflow learnings and development examples\, the speakers will explore how automation can be introduced incrementally to support clinical readiness today while preparing for future scale. \nAttendees will gain practical guidance on mapping their current workflows to an automation-ready platform\, reducing operational risk\, and building a clear path from development to GMP manufacturing. \nKey learning objectives: \nUnderstand how to automate cell therapy workflows without redesigning biology\nIdentify platform features that support clinical readiness and future scale\nLearn how closed\, modular systems reduce operational risk while preserving flexibility
URL:https://thebiocalendar.com/event/automating-cell-therapy-manufacturing-without-redesigning-established-workflows/
LOCATION:Online webinar
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260623T110000
DTEND;TZID=America/Los_Angeles:20260623T120000
DTSTAMP:20260522T081837Z
CREATED:20260519T145520Z
LAST-MODIFIED:20260522T081837Z
UID:10461-1782212400-1782216000@thebiocalendar.com
SUMMARY:Mastering Inspection: Strategies to Reduce Downtime and Ensure Quality
DESCRIPTION:This webinar explores why inspection in HMLV environments is inherently challenging and identifies the most common pain points faced by operations\, engineering\, and quality teams.
URL:https://thebiocalendar.com/event/mastering-inspection-strategies-to-reduce-downtime-and-ensure-quality/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-23-26-Koerber-Reg-1920x250-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260623T100000
DTEND;TZID=America/Los_Angeles:20260623T140000
DTSTAMP:20260522T081902Z
CREATED:20260511T125601Z
LAST-MODIFIED:20260522T081902Z
UID:10405-1782208800-1782223200@thebiocalendar.com
SUMMARY:Bio-Expo Live: Upstream Bioprocessing
DESCRIPTION:Bioprocess Online’s Bio-Expo Live is back with its series of live virtual events designed to empower biopharma professionals. Through these sessions\, attendees will have the chance to explore the newest equipment and solutions offered by our presenters\, aimed at addressing the current challenges within the drug development process. This interactive online platform ensures convenience and accessibility\, fostering an environment of learning and innovation for all participants. \nThe attendees of the Upstream Manufacturing session will have the chance to explore the newest equipment and solutions offered by our presenting suppliers essential to therapeutic areas from ADCs to vaccines. \nWhat can you expect? Short\, digital presentations with live interaction. You will have the opportunity to ask questions to better understand if they can meet your needs – all from the convenience of your computer! \nPlease note that this event is for biopharma companies or contract manufacturers seeking available products/solutions to help them overcome upstream manufacturing challenges.
URL:https://thebiocalendar.com/event/bio-expo-live-upstream-bioprocessing-4/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-2026-BEL-1280x720-upstream-scaled.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260622T110000
DTEND;TZID=America/Los_Angeles:20260622T120000
DTSTAMP:20260619T000253Z
CREATED:20260528T121901Z
LAST-MODIFIED:20260619T000253Z
UID:10536-1782126000-1782129600@thebiocalendar.com
SUMMARY:Driving Faster Clinical Trial Setup: How Humans and AI Collaborate to Improve Quality\, Speed\, and Agility in Study Build
DESCRIPTION:Study build inefficiency is rarely caused by a single failure point. Instead\, delays accumulate across fragmented protocol interpretation\, manual configuration\, iterative amendments\, and validation cycles that often surface issues late—when they are more costly to resolve. For many sponsors and CROs\, this has become the accepted baseline. The more important question is whether it needs to be. \nThis webinar explores how a more integrated human–AI collaboration model can address these challenges. Drawing on practical experience from study build environments\, we examine how AI can be applied not just to automate individual tasks\, but to support the full lifecycle—from protocol interpretation through configuration and validation. In this model\, AI contributes context-aware support grounded in clinical data structures and study design logic\, while clinical and operational experts guide decisions\, validate outputs\, and ensure regulatory alignment. \nWe will share how this approach is being implemented in practice\, including where AI can help reduce rework\, improve consistency in configuration\, and surface potential downstream issues earlier in the process. Particular focus will be given to how teams are balancing increased speed with the need for control\, auditability\, and quality. \nThrough real-world examples and live demonstration segments\, attendees will gain a practical understanding of how human expertise and AI can work together to improve study build performance—enabling faster timelines while maintaining rigor. \nWhy attend:\n– Gain a realistic\, experience-based perspective on AI in clinical operations\n– See how these approaches are being applied within active study environments\n– Understand how to improve speed without compromising quality or oversight
URL:https://thebiocalendar.com/event/driving-faster-clinical-trial-setup-how-humans-and-ai-collaborate-to-improve-quality-speed-and-agility-in-study-build/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-22-26-Endpoint-eblast-700x200-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260622T110000
DTEND;TZID=America/Los_Angeles:20260622T120000
DTSTAMP:20260522T081936Z
CREATED:20260521T162343Z
LAST-MODIFIED:20260522T081936Z
UID:10504-1782126000-1782129600@thebiocalendar.com
SUMMARY:From Variable to Predictable: How Intensified Upstream Processing Improves Scale-Up and Tech Transfer
DESCRIPTION:As biomanufacturers face increasing pressure to boost productivity\, reduce costs\, and accelerate timelines\, traditional scale-up approaches can introduce variability and performance drift. Intensified upstream processing offers a more scalable\, efficient path forward—helping maintain product quality\, process stability\, and regulatory compliance from development through GMP manufacturing. \nIn this webinar\, Thermo Fisher Scientific experts share best practices and real-world insights on implementing intensified upstream strategies\, supported by advanced automation\, process analytical technologies (PAT)\, and data-driven control. \nIn this session\, you will learn how to:\n~ Drive productivity with intensification strategies\n~ Accelerate timelines using high-density inoculation and optimized seed trains\n~ Increase output through perfusion and hybrid processing models\n~ Improve consistency with automation\, PAT\, and real-time control\n~ Enable reliable scale-up with standardized tech transfer approaches \nKey challenges addressed:\n~ Performance drift and variability during scale-up\n~ Limited productivity with traditional processes\n~ Long development and seed train timelines\n~ Inconsistent results across sites \nDiscover how intensified upstream processing can help you scale with confidence while improving efficiency\, consistency\, and speed across your operations.
URL:https://thebiocalendar.com/event/from-variable-to-predictable-how-intensified-upstream-processing-improves-scale-up-and-tech-transfer/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-22-26-Thermo-Reg-1920x250-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260618T110000
DTEND;TZID=America/Los_Angeles:20260618T120000
DTSTAMP:20260522T082002Z
CREATED:20260519T130313Z
LAST-MODIFIED:20260522T082002Z
UID:10457-1781780400-1781784000@thebiocalendar.com
SUMMARY:Breaking the CLD Bottleneck: Generate Stable High-Producing Clones in 14 Weeks
DESCRIPTION:Given its inherent time and resource demands\, variability in productivity\, and the rising complexity of monoclonal antibody (mAb) modalities—including bispecific antibodies (bsAb) and fusion proteins—cell line development (CLD) has become a leading constraint on bioprocess development. \nDesigned to address these constraints\, the Gibo™ CHOvantage™ GS CLD kit is a transposon-based CHO-K1 CLD platform that offers a solution for the accelerated production of stable\, high-performing cell lines. Using this platform\, mAb\, bsAb\, and Fc-fusion protein cell lines were generated in less than 14 weeks with high-titer pools consistently producing up to 5 g/L and corresponding stable clone titers reaching greater than 7 g/L. Selected clones were successfully scaled to bench scale and found to be stable in production and product quality for up to 100 generations. Collectively\, this demonstrates that the CHOvantage™ platform enables rapid\, robust\, and scalable generation of high-producing cell lines and represents an effective solution for accelerating biotherapeutic development.
URL:https://thebiocalendar.com/event/breaking-the-cld-bottleneck-generate-stable-high-producing-clones-in-14-weeks/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-18-26-Thermo-LinkedIn-1280x720-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260618T110000
DTEND;TZID=America/Los_Angeles:20260618T120000
DTSTAMP:20260526T212757Z
CREATED:20260515T203642Z
LAST-MODIFIED:20260526T212757Z
UID:10445-1781780400-1781784000@thebiocalendar.com
SUMMARY:When Art Meets Science: Creative Chromatography Solutions for Complex Small Molecules
DESCRIPTION:Difficult to purify small molecules pose a big challenge for drug developers. Working with a CDMO that has specialized expertise in chromatography ensures that no matter the purification challenges or scale\, your program can be taken care of. Learn more…
URL:https://thebiocalendar.com/event/when-art-meets-science-creative-chromatography-solutions-for-complex-small-molecules/
LOCATION:Online webinar
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://thebiocalendar.com/wp-content/uploads/2026/05/06-18-26-MilliporeSigma-eblast-700x200-1.png
END:VEVENT
END:VCALENDAR