White Paper: Validation Guidance for Residual Host Cell DNA Testing of Biologics

Assurance of product safety and quality are top of mind for all biotherapeutic manufacturers. A variety of analytical assays are implemented for this purpose. Some are presence/absence only to detect microbial contamination, such as bacterial or viral. Others are quantitative, to measure the amount of impurities, such as host-cell protein or host-cell residual DNA.

QC methods using these assays require validation per International Conference on Harmonization guidelines, ICH Q2(R1), ‘Validation of Analytical Procedures’, to ensure that the analytical procedure is suitable for intended use in assessing the quality and reliability of analytical test results.

In this white paper, we will discuss the components of a method validation per ICH Q2(R1) in the context of a quantitative polymerase chain reaction (PCR) assay for sensitive, accurate and rapid quantitation of residual DNA from a variety of host-cell systems, including Chinese Hamster Ovary (CHO), E. coli, Vero and Human/Human Embryonic Kidney 293 (HEK293).

You will learn:

  • Key things to consider when establishing acceptance criteria
  • Overview of how to design validation studies
  • Review of data from validation of a qPCR assay for residual host cell DNA quantitation


Who should read this white paper:

  • Process Development Scientist
  • Analytical Development Scientist
  • Quality Control, Quality Assurance Scientist,
  • Regulatory/CMC Managers

 

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  • The resDNASEQ Quantitative DNA Kit is a qPCR-based system for the detection of host cell DNA from various cell lines (CHO, HEK293, Human, E. coli, Vero, MDCK, Pichia Pastoris, NS0, and more). Would you like a Thermo Fisher technical expert to contact you (by email or telephone) to learn more about resDNASEQ Quantitative DNA Kit?


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