Andrew Passarotti
Associate Director - Raw Materials Planning Beam Therapeutics
Andrew Passarotti is Associate Director of Raw Materials Planning at Beam Therapeutics, where he drives supply chain strategies that support innovative gene editing and therapeutic development. With extensive experience at Resilience, Bluebird Bio, CSL Seqirus, and Novartis, Andrew has led production planning, warehouse operations, ERP system integrations, and GxP-compliant raw material onboarding. He is dedicated to ensuring seamless manufacturing support for complex biologics while advancing operational efficiency and compliance. Guided by his mission to “honor the patients of the past, walk with the patients of the present, and persevere for the patients of the future,” Andrew aligns supply chain excellence with patient impact.
Seminars
- Managing enzyme stability, shelf-life mismatches, and plasmid production variability to ensure consistent quality and scalability
- Navigating raw material constraints with limited GMP-grade enzyme suppliers and critical sourcing strategies
- Applying risk assessment tools such as FMEA and ICH-aligned frameworks to identify vulnerabilities, qualify suppliers, and establish multi-sourcing strategies for critical raw materials and GMP-grade enzymes
As nucleic acid–based therapeutics advance from research to commercialization, ensuring quality consistency and GMP compliance across the entire product lifecycle has become a defining challenge. Participants will gain actionable strategies to strengthen quality oversight, enhance inspection readiness, and de-risk production from plasmid DNA to final drug product through proactive, integrated GxP approaches.
This workshop will address:
- Implementing risk-based Quality Management Systems (QMS) that ensure DNA integrity, traceability, and process control across both plasmid and synthetic DNA platforms
- Addressing persistent alignment challenges between interstitial standards, risk assessments, and evaluations
- Managing variability in pDNA material quality, testing methods, and evaluationcriteria, and identifying approaches to harmonize standards across the industry
- Determining which analyses are essential versus optional for Certificates of Analysis (CoAs) to balance compliance requirements with operational cost efficiency.
