
Professor
at Czech Academy of Sciences
Dr. Mikael Kubista is a globally recognized expert in quantitative PCR (qPCR) and digital PCR (dPCR), and a coauthor of the foundational MIQE and dMIQE guidelines. He has also contributed to ISO standards and the American Association of Pharmaceutical Scientists (AAPS) white paper on PCR use in cell and gene therapies. A serial entrepreneur, Dr. Kubista co-founded MultiD Analysis, Tataa Biocenter, Life Genomics, and SimSen Diagnostics—companies focused on molecular analysis, diagnostics, and ultrasensitive sequencing. His work has been recognized with the Frost & Sullivan Award for Customer Value Leadership in 2013. Currently, he splits his time between BIOCEV in Prague and Gothenburg University in Sweden. Most recently, he co-founded Precision BioAnalytics to support advanced therapy development through high-quality molecular analysis services.
Education
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Best Practices for qPCR and dPCR Assays in Cell and Gene Therapy Development

Episode 2: The Future of Digital PCR and Quantitative PCR

Episode 1: Integrating PCR with Emerging Technologies

Teach Me in 10: Accelerating Cell and Gene Therapy Development

The Future of Diagnostics: Advancements, Challenges and Opportunities

Precision qPCR and dPCR in the Discovery and Development of Cell and Gene Therapies
These tools are widely used during CGT development for example in biodistribution, pharmacokinetics and pharmacodynamics of the investigational lead molecule. But many samples, including tissues rich in nucleases, lipids and other inhibiting substances and target molecules that are short or contain modified bases, can be challenging to work with. For these types of samples, assay design using advanced strategies, concentration standards, spike-in controls and validated normalization is key for reliable analyses.
In this webinar, Dr. Kubista will present strategies for implementing reliable qPCR and dPCR analysis in CGT development while highlighting best practices for adhering to MIQE and dMIQE guidelines and the recently released ISO standard, ISO 20395:2019.