What does it take to turn breakthrough biology into successful in vivo therapies? As 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. Join Chief Editor Erin Harris for a special Cell & Gene Live discussion with Robert...
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...
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. Using real-world insights from Kindeva’s Bridgeton facility, attendees will explore how...
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....
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. Attendees...
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. Attendees will learn how combining LC-MRM with a single UV280 measurement can generate reliable...
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. Attendees will gain: • A clearer view of available recruitment and engagement solutions • A more efficient way to...
Discover how a simple redesign of the AAV helper plasmid could make gene therapy manufacturing more efficient and cost-effective. In 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. You'll...
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...
This expert panel will discuss how digital documentation is reshaping inspection readiness. Panelists will explore the role of electronic batch records, integrated quality systems, and automated workflows in supporting compliance with ALCOA+ principles, while enabling real-time visibility and faster audit response.
