FEBRUARY 2025LIFE SCIENCES REVIEW8By Jessica Wilson Rayse, Assoc Director of Product Management, Accugenix, Charles River LaboratoriesMICROBIOLOGICAL CONSIDERATIONS FOR ACHIEVING DRUG MANUFACTURING EXCELLENCEharmaceutical and consumer care companies share the ultimate goal of producing a product safe for consumption, free of harmful microorganisms that cause disease or negatively impact the product. Contaminated products can result in patient illness, product recalls, drug shortages, damage to brand reputation, financial losses, and even criminal proceedings. Given the negative consequences of contamination and product recalls, manufacturers should develop and be committed to a contamination control strategy. This consists of utilizing all the knowledge and experience of science and manufacturing to design and implement controls to prevent contamination. This strategy should be considered for all equipment, personnel, materials, procedures, processes, and facilities. As such, the contamination control strategy should be developed by a cross-functional group of people. Central to the contamination control strategy is knowledge of microbiology.By understanding what organisms are present and at what level they are located in the manufacturing environment, controls can be put in place to protect the product from contamination. The most effective way to do this is to track and trend bioburden counts and microbial identifications. This acts as an early warning surveillance system by allowing you to see changes and intervene quickly. If contamination does occur, it's important to be able to trace the contaminant back to the environment to find root cause and prevent it from happening pJessica Wilson RayseIN MY OPINION
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