PD/ CMC: HYPERstack, flask, wavebag and 2-200L bioreactor operation; cell line development; TFF, UF and chromatography in downstream purification; Scale up / scale down; Tech transfer; FDA, EMA, GMP and ICH guidance and regulatory fillings; QbD and DOE.
Gene Therapy: viral vectors design and cloning; Viral vector upstream and downstream process; In vivo and in vitro viral gene delivery and characterization; IVT (In Vitro Translation) mRNA production
Leadership: CDMO and CRO management; people recruitment, engagement, motivation and performance evaluation
Bioinformatics/Data Processing: robust design of experiments, statistical analysis and data and rational-driven process design
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