Purification of Monoclonal Antibodies for Human Clinical Use: Validation of DNA and Retroviral Clearance
The production of therapeutic grade monoclonal antibodies using mammalian cell culture requires the development of a purification process that consistently yields a safe and efficacious product. Process validation studies provide the assurance that the purification process is capable of reducing the levels of potential contaminants to safe and acceptable levels.
The monoclonal antibody purification process used at Celltech has been validated for its ability to remove DNA and retrovirus by means of challenge studies. Moloney Murine Leukaemia Virus and 32P-labelled murine hybridoma DNA were used to challenge individual chromatography steps that had been scaled-down to mimic the full-scale manufacturing process. These studies have demonstrated that the risk factors associated with contaminating DNA and virus can be substantially reduced by the purification procedure described here.
KeywordsAffinity Chromatography Purification Process Sodium Citrate Buffer Moloney Murine Leukaemia Virus Anion Exchange Column
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