Key result
Execution of a corrective and preventative action (CAPA) plan, including disposal of contaminated materials and replacement of raw material, allowed the resumption of MMV-free production.
Population
CHO (Chinese hamster ovary) cell-based production systems for biologic drugs
Design
Case_report
Authors
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CAPA restored MMV-free CHO production after silent contamination; leaves open optimal PCR screening of animal-free raw materials.
Case Report
MMV contamination in CHO cell cultures can be silent and requires PCR for reliable detection, highlighting that even animal-free media components can be a contamination source.
Moody et al. (2011) conducted a case report in Mouse Minute Virus (MMV) contamination. Corrective and preventative action (CAPA) was evaluated on Resumption of MMV-free production. Execution of a corrective and preventative action (CAPA) plan, including disposal of contaminated materials and replacement of raw material, allowed the resumption of MMV-free production.
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