Abstract
One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA (rcDNA). To determine small amounts of DNA (around 100pg) that may be in a biologically-derived drug substance, an analytical method should be sensitive, robust, reliable and accurate. In principle, three techniques have the ability to measure rcDNA: radioactive dot-blot a type of Hybridization; Threshold and quantitative Polymerase Chain Reaction (qPCR). Quality Risk Management (QRM) is a systematic process for evaluating, controlling and reporting of risks which may affects method capabilities and supports a scientific and practical approach to decision making. This paper evaluates by QRM, an alternative approach to assessing the performance risks associated with quality control methods used with biopharmaceuticals, using the tool Hazard Analysis and Critical Control Points (HACCP). HACCP provides the possibility to find the steps in an analytical procedure with higher impact on method performance. By applying these principles to DNA analysis methods, we concluded that the radioactive dot-blot assay has the largest number of critical control points (CCP), followed by qPCR and Threshold. From the analysis of hazards (i.e. points of method failure) and the associated method procedure CCP, we concluded that the analytical methodology with the lowest risk for performance failure for rcDNA testing is the qPCR.
- Analytical Methodology
- Biopharmaceutical
- HACCP
- Quality Control
- Quality Risk Management
- Residual Cellular DNA
- Received September 20, 2016.
- Accepted January 23, 2018.
- Copyright © 2018, Parenteral Drug Association
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.
Log in using your username and password
Log in through your institution
Purchase access
patientACCESS
In This Issue
Jump to section
Related Articles
Cited By...
- No citing articles found.