Analytical Approaches for Quantifying Residual Host Cell and Plasmid DNA in Biotherapeutic Production
8am PDT| 11am EDT| 3pm GMT| 4pm CET
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 residual testing solutions, and the benefits of using commercial kits for residual DNA testing, including shorter process development time, simplified regulatory acceptance and how they help to enable focus on process-specific development tasks.
Attend this webinar to discover:
- 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 of using a commercial kit for residual DNA quantitation
- Unique benefits of using a solution from Thermo Fisher Scientific
Speaker
Dr. Ilaria Scarfone
Field Application Specialist
Thermo Fisher Scientific
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