RECENT WEBINARS
Translating Stem Cell Programs To GMP
A detailed exploration of challenges in advancing stem cell programs to GMP, highlighting strategies to control variability, strengthen process design, and support reliable clinical‑stage manufacturing.
Integrated Thinking for Complex FIH Programs
See how deep expertise, integrated thinking, and cross-functional collaboration turn complex molecule challenges into opportunities, strengthening early decisions and improving First‑in‑Human outcomes.
Concept To Market: Scaling And Manufacturing Semi-Solid Topical Drugs
Learn how formulation, processing, and scale‑up choices impact the stability, structure, and performance of semi‑solid topicals while ensuring consistent quality through development.
Selecting A Prefillable Syringe System With Confidence
Discover an advancement in the prefillable syringe market, uniquely integrating the syringe barrel, plunger, and needle shield/tip cap into a fully harmonized, verified system from a single supplier.
Designing Drug Substance Processes For Fill-Finish Compatibility
Integrated KBI and Argonaut solutions streamline drug substance to fill-finish transitions, resolving quality challenges, reducing delays, and accelerating timelines through coordinated processes and practical strategies.
Next-Level Cell Lines: An Integrated Approach To Biologic Innovation
See how AI-driven tools and optimized platforms are accelerating biologics development, delivering high-titer clones in weeks, and paving the way for integrated design of cell lines and genetic systems.
Five Practical Considerations To Move From Concept To Clinic
Learn more about five key factors for advancing targeted in vivo LNP programs, from formulation and targeting strategies to bioanalytical readiness and scalability.
Eliminate Risk From Your Viral Vector Tech Transfers
Explore strategies to simplify viral vector tech transfers, reduce risk, and maintain quality under tight timelines, as well as a case study that demonstrates how to streamline this critical process.
Navigating Regulatory Expectations For Injectable Packaging
Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.
Critical Path For Gene Therapy: AAV Analytical Lifecycle Considerations
Explore considerations for phase-appropriate AAV characterization and release activities from pre-clinical to late-phase products. Review validation challenges and paths for maturation of analytics.
Raising The Bar In Gene Therapy
Learn how a science-driven and digitally structured approach reduced onboarding timelines for gene therapy from 12 months to just 3, setting a new benchmark in technology transfers.
Extrusion-Based ASD Scale-Up: Performance Through Process Understanding
Explore the formulation and manufacturing considerations for amorphous solid dispersions (ASDs), with a focus on hot melt extrusion (HME) as a scalable and cost-effective technology option.
Streamlining pDNA: Capacity, Complexity, And Cutting-Edge Solutions
Learn how flexible facility design and process innovation are accelerating pDNA manufacturing, as well as key strategies to avoid scale-up pitfalls and meet growing therapeutic demand.
Are You Keeping Pace With Oligo Synthesis Optimization?
The rapidly expanding oligo market demands optimized RNA synthesis. Examine key innovations and workflow insights to maximize resources and control long-term manufacturing costs.
From Readiness To Results: Unlocking Capacity For Expanding Product Demand
Learn the six pillars that bridge operational readiness and operational excellence. Discover a proven framework to build a resilient, high-performing manufacturing operation and unlock necessary capacity.
Advancing Topical Formulations With Innovative Preclinical Models
A robust formulation development approach integrates scientific principles, systematic formulation development, and preclinical models to facilitate early identification of candidates with poor developability.
Accelerate Your pDNA And mRNA Process Development
Explore a structured approach to optimizing and scaling plasmid DNA production using E. coli, with insights into key growth parameters, benchtop feasibility, and pilot-scale performance.
Driving Robust Tech Transfer In Biologics: Computational Fluid Dynamics (CFD) Simulation
Computational Fluid Dynamics simulation is essential for robust biologics tech transfer. See how this predictive tool optimizes critical scale-up processes, reducing risk and expediting time to market.
Navigating Commercial Cell Therapy Manufacturing
Explore expert insights on manufacturing strategies, quality management, scalable production, and digital tools that enhance collaboration and ensure consistent, efficient multi-product facility operations.
Enhancing Viral Vector Sterile Filtration: Process Efficiency And GMP Alignment
Explore filtration strategies that improve viral vector yield and quality, with insights on AAV and lentivirus workflows, plus practical guidance for implementing PUPSIT in line with requirements.
Innovations, Solutions, And USP <1062> With Scale Up
Optimize tablet compression by simplifying calibration, speeding up changeovers, and utilizing advanced laser inspection to prevent critical punch tip wear and maintain quality.
How To Select The Right Bioanalysis CRO For Your Program
The right bioanalysis CRO accelerates progress, while the wrong one can derail outcomes. When every provider claims speed and credibility, how do you confidently choose the right partner?
The Future Of Gene Therapy Production: Enriching Full Capsids, Reducing Costs
Explore how intensified upstream processing enriches full AAV capsids, reduces impurities, and lowers manufacturing costs. Learn how extended culture duration drives better outcomes.
Developing Your Risk-Based Approach To Single-Use System Integrity
Explore how a holistic approach to single-use system integrity can strengthen contamination control, improve operational efficiency, and meet evolving regulatory expectations in manufacturing.
Smarter CMC Strategies To Accelerate Next-Gen Biologics To The Clinic
Learn how process design and cross-functional collaboration mitigate risks and accelerate the path from early development to FIH manufacturing through real-world case studies of practical approaches.
Unlocking Allogeneic Cell Therapy: Exploring Durable Approaches
Learn how genome engineering and iPSCs are being used to overcome the critical challenges of durability and host immune clearance in both clinical and preclinical settings for allogeneic cell therapies.
Game-Changing CLD Platforms: Strategies, Technologies, Workflows
Selecting the right cell line platform is complex. Learn how flexible strategies, integrated technologies, and expert workflows enable high productivity, rapid timelines, and a de-risked path to clinical success.
From Plasmids To Cell-Free DNA Using Megabulb DNA
Discover a non-viral approach for T cell engineering that overcomes limitations of viral transduction. Learn how a novel single-stranded DNA template and CRISPR technology deliver a scalable solution.
AI In Action: Driving Operational Excellence In Life Sciences
Discover how combining domain expertise with advanced AI and data engineering automates compliance, accelerates readiness, and provides real-time insights for confident decision-making.
Integrated Manufacturing To Mitigate CMC Risks, Simplify Commercial Supply
Leveraging cross-functional coordination between sites, harmonized tech transfers, one quality system, and synchronized team activities can streamline regulatory submissions and deliver high-quality commercial outcomes.