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To verify product quality, the amount of residual DNA in a drug’s final dosage form must meet guidelines established by multiple regulatory agencies. Each regulatory agency has specific guidelines for acceptable limits depending on the product and therapeutic modality.
In this webinar, we’ll discuss the challenges, risks, and considerations involved in developing and using In-house developed residual testing solutions, and the benefits of using commercial kits for residual DNA testing, including shorter process development time, simplified regulatory acceptance, and helping to enable focus on process-specific development tasks.
Join this webinar to learn more about:
- The challenges in terms of cost and resources involved in using “homebrewed” DNA quantitation solutions
- The regulatory considerations in quantitating residual DNA in a biotherapeutic
- The overall benefits to using a commercial kit for residual DNA quantitation
- Unique benefits of using a solution from Thermo Fisher Scientific
Ilaria Scarfone
Scientist III, Field Applications – Bioproduction Group at Thermo Fisher Scientific
Ilaria Scarfone is a Field Application Specialist in Thermo Fisher Scientific's Pharma Analytics team since September 2019. She currently lives in Pisa and supports clients in South West Europe. Ilaria completed her PhD in Industrial Biotechnology at the University of Milan in collaboration with the Cell Biology Research Center of Montpellier and subsequently spent 2 years at the Grenoble Atomic Energy Commission as a Post-Doc. In addition to her academic research background, Ilaria successfully completed a Master’s in Business and Administration from the IAE in Montpellier in 2018, before integrating Thermo Fisher Scientific as a technical specialist for Pharma Analytics portfolio.