Microbial control: Mold control and detection in biological drug substance facilities: an industry perspective
Mold will never be a glamorous subject but it is one which impacts every biopharmaceutical company and the prevalence of mold events can be costly. The Microbial Control workstream have worked out how to tackle this common issue in their Mold control and detection in biological drug substance facilities paper.
By putting the paper into practise, companies can expect to be able to isolate mold event, have consistent mold monitoring, see a reduction in the instances of mold and ultimately save significant drug substance costs.
Derek Willison-Parry, BioPhorum Drug Substance Phorum Lead team says: "soon after publication, 11 member companies carried out a gap analysis of this paper with their company's procedures and developed implementation plans to move to the best practice described.”
The team analyzed ways in which to monitor and respond to mold and also implement better methods of prevention. The paper puts emphasis on the benefits of adequate mold trending procedures rather than focus on single mold isolation events. Through looking at how facilities are set up and maintained the team saw ways in which the root causes of mold could be identified and acted upon.
Recommendations are made within the paper to assist biological manufacturers refine their current mold control strategy and develop control strategies for new facilities, processes and products.
|Mold control and detection in biological drug substance manufacturing facilities - and industry perspective.pdf|
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