David Dobnik
Company: National Institute of Biology
Job title: Senior Research Associate
Seminars:
Roundtable Discussion: Overcoming Tech Transfer Hurdles to Maintain Product Quality, Consistency & Regulatory Compliance 12:00 pm
Discuss best practices for transferring manufacturing processes between teams or sites to ensure consistency, quality, and regulatory compliance without delaying timelines Explore the key challenges of scaling up gene therapy production and strategies for minimising bottlenecks to maintain efficient timelines Highlight the importance of collaboration across R&D, manufacturing, and quality control teams to ensure smooth…Read more
day: Day Two
Chair’s Opening Remarks 9:25 am
day: Day Two
Chair’s Closing Remarks 3:40 pm
day: Day Two
Confronting the Challenges of Viral Vector Genome Integrity for Consistent Gene Therapy Outcomes 4:35 pm
Understanding accurate detection of viral vector genome integrity is crucial to ensure the vector carries the correct genetic material without mutations, deletions, or rearrangements that could impact therapeutic efficacy or safety Address how variability in the efficiency of viral packaging and transduction processes can lead to inconsistencies in genome integrity, requiring robust methods to quantify…Read more
day: Day One
Choosing Between qPCR vs. dPCR vs. ddPCR for Robust Analytics & Regulatory Compliance 9:00 am
In gene therapy development, accurate quantification of viral vectors is critical for assessing potency and ensuring therapeutic efficacy. This discussion will explore the strengths and limitations of qPCR, dPCR, and ddPCR, and how selecting the right method impacts early versus late-stage gene therapy processes. PCR Method Comparison Pros & Cons: Overview of qPCR, dPCR, and…Read more
day: Pre-Conference QC Readiness Track B - AM