Navigating Assay Re-Development & Transfer to Reduce Risk & Delays in GMP Testing

• Addressing challenges in transferring assays from research into GMP testing environments

• Managing redevelopment of complex assays and adapting to new readout platforms

• Aligning timelines and coordinating qualification across internal teams and CRO partners

Presented by Sviatlana Rose, Principal Scientist at Sanofi

Sviatlana Rose holds an Associate Degree in Mathematics, Science, and Pre-Engineering from Cape Cod Community College, as well as a Bachelor of Arts and Master of Arts in Biochemistry and Molecular Biology from Boston University. Following her graduate studies, Sviatlana conducted research at the Massachusetts Institute of Technology (MIT), where she contributed to the development of drug delivery platforms for single-injection vaccination technologies. Prior to joining Sanofi, Sviatlana spent five years at Solid Biosciences, a gene therapy company, where she was a member of the Analytical Development Cell-Based Assay team. In this role, her primary focus was the development of Mechanism of Action (MoA)-reflective cell-based potency assays to support the clinical development of gene therapy programs. While leading the development of infectivity assays (TCID50) using digital droplet PCR (ddPCR) methodology, Sviatlana also spearheaded cell-based assay transfer, optimization, pre-qualification, and qualification activities in collaboration with a Contract Research Organizations (CRO). Currently, Sviatlana serves as a Principal Scientist within Sanofi’s BioAnalytical (BioA) team, where she focuses on the development of functional potency assays for gene therapy products. In her role as Analytical Technical Lead, she provides strategic scientific guidance and technical oversight for assay development programs, leads cross-functional collaborations to ensure alignment with regulatory requirements and quality standards, and mentors team members in advanced analytical methodologies. She is responsible for ensuring the successful progression of gene therapy programs from early development through clinical phases.