RECENT WEBINARS
Building a Global Manufacturing Network: "Dual-Sourcing" Commercial Strategies
EU entry after FDA approval puts launch timing and supply continuity at risk. QP release, importation pathways, and distributed manufacturing networks all shape whether a biologic reaches the market predictably.
Precision At Scale: Optimizing Cell-Free DNA Manufacturing For mRNA Vaccines
Backbone-free enzymatic DNA templates can improve polyA integrity, long-transcript quality, and RNA yield, with implications for IVT timelines and regulation.
Developing Custom GMP Lipids: A Patient-Driven Partnership
Custom lipid programs depend on how process development and manufacturing teams collaborate, from first design through scale-up to GMP production for LNP-based therapies.
Smarter Lead Selection And Faster Representative Material
Accelerate biologics development with earlier high-titer material, reduced CMC risk, and faster lead selection using transposase-based vectors and stable bulk pools.
Design Verification Done Right: Smarter Strategies For Prefillable Syringes
A practical framework for planning and justifying design verification programs for prefillable syringes, covering test selection, acceptance criteria, and sample-size rationale within a risk-based approach.
IND In As Little As 6 Months: Now Beyond mAbs - Accelerating Bispecifics, Fc-Fusions And High-Concentration Biologics To The Clinic
Listen as our experts outline expanded accelerated DNA-to-IND pathways for a broader range of biologic modalities, examining how expression technologies and integrated CMC strategies can shorten development timelines.
Scaling Cell And Gene Therapy Manufacturing
Artificial intelligence is reshaping healthcare. Discover proven strategies for secure, compliant AI adoption, strong data governance, and seamless integration to improve patient outcomes.
De-Risking The Path To GMP Manufacturing At Another Organization
Successful tech transfer depends on more than moving a process. Early alignment across process readiness, analytical strategy, governance, and decision-making helps reduce execution risk.
Breaking The Concentration Barrier: New Long-Term Stability And PK Data For Subcutaneous Nanotrastuzuma
Nanoparticle engineering enabled a 440 mg/mL trastuzumab suspension that clears viscosity and stability barriers limiting conventional high-dose subcutaneous biologics formulations.
Unlocking Challenging Targets With Macrocycle DNA-Encoded Libraries
Discover how macrocycle DNA-encoded libraries can uncover new opportunities for challenging targets and help researchers translate promising screening hits into starting points for drug discovery.
Beyond The Starting Material: A Path To GMP Manufacturing Success
Explore how starting material decisions affect cell therapy development, tech transfer, and GMP readiness, as well as practical guidance for aligning material requirements with manufacturing processes.
Building Oral Dosage Forms for Speed Today And Success Tomorrow
Move toward the clinic with confidence using integrated development strategies that support smarter decisions and more efficient product development.
Improving Clinical Translation For ADCs And Immuno-Oncology With Human-Relevant Tumor Models
When preclinical tumor models fail to reflect clinical reality, promising therapies pay the price. This webinar examines how advanced patient-derived organoids and 3D models improve predictive accuracy for ADC and immuno-oncology programs.
A Smarter Microbial Approach To Therapeutic Peptide Manufacturing
See how microbial expression can improve therapeutic peptide yields, reduce costs, and simplify downstream processing while supporting development from research through manufacturing.
Establishing A Risk-Based Containment Strategy For High-Potency Micronization
This session presents a risk-based framework for high-potency micronisation, illustrated through a practical case study that spans development to commercial scale.
Scaling AAV Manufacturing To 1000 L: Strategies For Robust Production
Learn how integrated cell line, media, and process design can support consistent AAV production at larger volumes while maintaining productivity and quality, as well as reducing scale-up risk.
The Next Generation Of USP <87> Testing
Upcoming USP <87> changes are driving risk-based in vitro testing. Learn how to prepare for new requirements, validation impacts, and continued compliance.
Beyond Breakdowns: Building A Culture Of Proactive Maintenance
Reactive maintenance can drive costly downtime, deviations, and reliability challenges. Learn how proactive maintenance strategies help improve equipment uptime and strengthen compliance.
Overcome Early Development Challenges Before They Impact Your Program
Poor manufacturability and immunogenicity can delay development. Learn how early developability assessments support IND readiness.
How Sponsors Should Evaluate Manufacturing Resilience
Learn how continuity planning, technology transfer capabilities, global network flexibility, and digital visibility contribute to resilient supply chains and help protect programs from disruption.
A CCS Is A Purpose-Built Machine, Not A Black Box: Understand The Workings
Learn how to transform your contamination control strategy into a dynamic operational framework that identifies risks and strengthens facility control.
Selecting A Test Method For Your Container System
Selecting CCIT requires matching methods like vacuum decay to product traits. Assess liquid conductivity, headspace, and lifecycle risks to build a compliant leak-detection strategy.
When Unexpected Particles Threaten Your Biologic
Particle contamination risks biologic safety. Advanced tools like Raman and SEM-EDS identify root causes fast to support robust, regulator-ready strategies that protect product quality.
Controlling Nitrosamine Risk In Drug Products: Detection, Formation, And Control Strategies
Bioprocess control relies on clear insight into cell health. Automated tracking cuts risk, saves time, boosts yield, and helps scale up fast to ensure smooth, top quality batch production runs daily.
Enhancing AAV Manufacturing Yield Via Mini-Helper Plasmid
Learn how rational plasmid engineering and promoter optimization can significantly improve AAV productivity while reducing plasmid burden, paving the way for more efficient and scalable viral vector manufacturing.
When High-Stakes ADC Decisions Can't Wait for More Material or Better Data
Learn how a material-sparing analytical workflow can generate reliable data, reduce dependence on calibration assays, and support faster, more confident candidate evaluation.
Modular VFlexible Aseptic Filling Lines
Modular suites with built-in contamination control streamline sterile manufacturing—supporting complex products, faster timelines, greater flexibility, less disruption, and scalable fill‑finish.
Breaking the Titer Ceiling: Smarter Media Design for Higher Productivity
A bottom-up, data-driven media design approach shows how targeted nutrient optimization overcomes metabolic limits to boost culture performance and titer while maintaining product quality and process consistency.