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Decoding AAV Manufacturing:
Navigating Critical Quality Attributes
and their Analytics
Presenter:
Roland Pach, PhDGlobal Analytical Expert, CMC, CGT, & Alternative Formats,
Roche
Roland Pach, PhD holds a doctoral degree in molecular parasitology from the University Fribourg, where he analysed the intracellular trafficking of transgenic RNA in trypanosomes.
Prior to Roche, he was leading a DiTe vaccine manufacturing unit followed by building up the Analytical Development Department of Vaccines at Berna Biotech (now Jansen Vaccine).
As department head of Analytics Bioprocess Development at Merck-Serono, he supported with his team the process development activities and process characterization of late stage projects of fusion proteins and interleukins drug candidates.
At Roche, Roland is the global CMC analytical technical lead in the cancer vaccines and cell and gene therapy (CGT) area for more than 15 years. In his assigned area, he represents Roche-Genentech in external development projects, at industrial consortia like CGT BioPhorum and at numerous successful due diligence projects of in-licensing candidates or at merger of companies in the CGT fields. As editor and author at Springer Nature, he published several white papers and articles describing the current challenges of manufacturing and analysis of CGT drug products.
In his second role at Roche as global technical development leader, he successfully led new formats like immunotoxins from pre-clinics into entry to human (EiH, Phase 1).
