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Articles by Ilaria Scarfone
Reframing Residual DNA Testing: What It Is--And What It Isn't
By Ilaria Scarfone and Shriya Sahu, Thermo Fisher Scientific Residual host-cell DNA control is a central pillar of biologics quality and safety, requiring far more rigor than its long-standing presence in GMP workflows might suggest. Because biologics originate from living systems, the clearance and precise quantitation of nucleic acids from production cells remain regulatory expectations and key indicators of purification performance.
Reframing Residual DNA Testing: What It Is--And What It Isn't
By Ilaria Scarfone and Shriya Sahu, Thermo Fisher Scientific Residual host-cell DNA control is a central pillar of biologics quality and safety, requiring far more rigor than its long-standing presence in GMP workflows might suggest. Because biologics originate from living systems, the clearance and precise quantitation of nucleic acids from production cells remain regulatory expectations and key indicators of purification performance.
What goes into developing an in-house method for quantitation of residual host cell DNA?
Cell & Gene Therapy Insights 2024; 10(2), 179 DOI: 10.18609/cgti.2024.025 Robust product characterization and quality testing of cell and gene therapies ensures the safety, efficacy, purity, quality, and potency of the final therapeutic product. A key consideration for the process and product characterization process is deciding between in-house development of a test method, or adopting a commercial kit for quantitating residual host cell DNA in the manufacturing workflow.
Simplifying residual DNA quantitation and biotherapeutic manufacturing
Cell & Gene Therapy Insights 2023; 9(11), 1457–1464 DOI: 10.18609/cgti.2023.190 Meeting regulatory guidelines for any biologic depends on robust product characterization, and cell and gene therapies are no exception. The analytical data must prove the safety, efficacy, purity, quality, and potency of the final drug product.
Simplifying residual DNA quantitation in biotherapeutic manufacturing
Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format. 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.
Residual DNA testing in viral vector manufacture: exploring the challenges and solutions
Ilaria Scarfone (left), Field Application Specialist, Pharma Analytics, Thermo Fisher Scientific speaks to Mike Brewer, Director and Global Principal Consultant, BioProduction Division, Thermo Fisher Scientific Q IS: Mike, to begin, could you give a brief introduction and background on the residual DNA testing regulatory requirements in general, and why gene therapy products present some particular challenges?
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