About the Viral Vector Characterization & Analytical Development Summit

As a wave of novel viral vector-based therapies enter pipelines enabling greater payload efficiency then seen before, the spotlight it on ensuring characterization and analytical development to enable economically viable capsid production at scale.

With it crucial analytical method development keeps to pace with pipeline progress, in this new era biopharma teams are faced with the urgent need to gain clarity across regulatory expectations and fit-for-purpose analytical technologies to define robust CQA’s. With the end goal to leverage analytics for faster process development read-out and optimization, there’s heightened awareness of the importance of characterizing viral vectors to demonstrate confidence of product quality for patient safety.

To address key bottlenecks and provide learnings across industry’s priorities, the Viral Vector Characterization & Analytical Development Summit took place with updates from AAV, LV & RV strategies for cell, gene & vaccine pipelines, to inform thinking for the best analytical development path forward with precision, accuracy, quality and efficacy optimized throughout.

He Only Industry-Led Summit Dedicated to Accelerating Viral Vector Characterization & Analytical Development for Cell, Gene & Vaccine Therapies

In 2023, the industry is witnessed a renaissance in viral vector characterization. Spurred by widespread biopharma investment to engineer a new wave of novel capsids and faced with newly launched QbD frameworks by US Pharmacopeia and the FDA’s tightened guidance, the increased vector complexity is creating a new era for advanced analytical technologies to ensure precision and accuracy.

In the wake of significant collaborations including Vector Bio and iBET’s for high-throughput characterization, and the likes of Vertex and BMS announcing their priority to build out their internal analytical competencies, the inaugural Viral Vector Characterization & Analytical Development Summit arrived to pave the foundation for teams to further optimize process development and accelerate vector scale-up with GMP compliance in mind.

Uniting Characterization, Analytical, Formulation, Quality, Engineering, CMC and Process leaders, this industry-led summit was your only conference for cross-learning opportunities across AAV’s, LV’s & RV’s and more – so you could benchmark your work against rapid-analytical method development transforming your peers’ workflows, turnaround, and consistency.

Attendees stayed ahead of the curve, and joined the likes of Ultragenyx, Kite Pharma, BioMarin, Neogene Therapeutics, Pfizer and many more for a 3-day jam packed agenda, that tackled the biggest bottlenecks in:

Developing phase appropriate potency assays and packages to demonstrate specificity, sensitivity and accuracy of results to enable improved efficacy

Navigating the regulatory agencies’ expectation and define predictive CQA’s to provide sufficient data during IND for smooth approval process

Leveraging analytics to enhance process development and formulation capabilities to protect final product safety

Applying advanced analytical technologies and interpret datapoints effectively to streamline development and align analytics with programs scaling up quickly

Establishing novel characterization and analytical methods with rapid, precise and accurate results to deepen your understanding of your capsid biology, improve encapsulation efficiency, protect stability and minimize impurities

The one-stop-shop to build out analytical capabilities and characterization package, attendees joined 60+ technical leaders to gain practical takeaways improving analytical capabilities so critical to process development and ensuring quality for patients.

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