Mold will never be a glamorous subject but it is one which impacts every member company and the prevalence of mold events can be costly. The Microbial Control workstream have been working on how to tackle this common issue and are now pleased to see their Mold Control and Detection in Biological Drug Substance Facilities paper published in the PDA this month.
By putting the paper into practise, members 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, facilitator for the Microbial Control team says: “Even though the paper has just been published, already 11 member companies have carried out a gap analysis of this paper with their company’s procedures and have an implementation plan to move to the best practice described.”
The team has analysed 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. In the future, the Microbial Control workstream will use this paper to present an industry perspective on mold monitoring of biologic manufacturing processes to regulatory agencies to provide input regarding future regulations for non-sterile bulk biologic manufacturing.
The paper is available to PDA members on their website and can be accessed on the BPOG website here: