INSIGHTS ON CELL & GENE REGULATORY ISSUES
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![pre-filled GLP-1 receptor agonist pens-GettyImages-2225780922]( "GLP-1 Peptides Around The World Part III: EU Evolution – Expanded Expectations And Emerging Enforcement")
GLP-1 Peptides Around The World Part III: EU Evolution – Expanded Expectations And Emerging EnforcementNavigating GLP-1 development in Europe? Discover how stricter CMC, Annex 1, serialization, and supply chain requirements are influencing manufacturing strategies.
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![small-mole-cdmo-GettyImages-1465073057]( "Making Complex Science Dependable")
Making Complex Science DependableAdvance small molecule programs with the right mix of scientific expertise, scalable manufacturing, regulatory readiness, and analytical support from discovery to launch.
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![De-Risking Cell Culture Media Scale-Up For Late-Stage Manufacturing]( "De-Risking Cell Culture Media Scale-Up For Late-Stage Manufacturing")
De-Risking Cell Culture Media Scale-Up For Late-Stage ManufacturingExplore practical approaches to scaling cell culture media manufacturing, from supply assurance to evolving quality requirements, digital formulation tools, and strategies for controlling costs.
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![GettyImages-2198078409 - meeting]( "Pharmacovigilance Is Not A Checkbox: Rethinking Safety Monitoring From Day One")
Pharmacovigilance Is Not A Checkbox: Rethinking Safety Monitoring From Day OneCell and gene therapies demand a pharmacovigilance approach built from the ground up, not adapted from frameworks designed for conventional drug products.
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![Beyond Breakdowns: Building A Culture Of Proactive Maintenance]( "Beyond Breakdowns: Building A Culture Of Proactive Maintenance")
Beyond Breakdowns: Building A Culture Of Proactive MaintenanceReactive maintenance can drive costly downtime, deviations, and reliability challenges. Learn how proactive maintenance strategies help improve equipment uptime and strengthen compliance.
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![Focusing On Quality Unit Independence With Tatyana Matveeva, Ph.D.]( "Focusing On Quality Unit Independence With Tatyana Matveeva, Ph.D.")
Focusing On Quality Unit Independence With Tatyana Matveeva, Ph.D.In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tatyana Matveeva, Ph.D., an expert in cGMP manufacturing and regulatory compliance.
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![GettyImages-2178790629 cell]( "Accelerating CAR T-Cell Therapy Manufacturing For Autoimmune Disease")
Accelerating CAR T-Cell Therapy Manufacturing For Autoimmune DiseaseProactive alignment and integrated quality systems can shorten cell therapy timelines. Rapid tech transfer and in-house analytics support regulatory rigor and reduce scaling risks.
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![QIAsprint]( "Breaking The Limits Of Automated Sample Preparation")
Breaking The Limits Of Automated Sample PreparationAutomated nucleic acid purification can deliver high throughput without limiting flexibility or consuming valuable bench space. See how adaptable workflows support efficient sample preparation.
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![Mastercontrol webinar sept 2026]( "AI-Readiness In A Regulated World: A Practical Playbook For Life Sciences")
AI-Readiness In A Regulated World: A Practical Playbook For Life SciencesUncover how life science teams build defensible governance, maintain human oversight, and manage regulatory risks when adopting advanced digital tools.
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![GettyImages-2234439798-AI-Medicine-Trials-Drug-Development]( "CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture")
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And CultureDiscover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
