Would you like to see your presentation here, made available to a global audience of researchers?
Add your own presentation or have us affordably record your next conference.
Consumer awareness of probiotics and their connection to overall health is driving significant growth in global probiotics markets. Projections estimate a market size of USD 105.7 billion by 2029. In this evolving landscape, probiotics have been integrated into both human and animal diets and have transitioned from being primarily powder, tablet, and capsule supplements to being incorporated into a wide array of foods. Regardless of product format, probiotics manufacturers follow current good manufacturing practices (cGMP) to ensure quality and safety. However, these guidelines do not contain the specifics necessary to meet the unique challenges of working with live microorganisms. One challenge that the industry routinely encounters is the quantification of viable probiotic microorganisms. These counts impact the efficacy, safety, and quality of products. Managing, maintaining, and improving quantification is essential to manufacturing consistent ingredients and finished products. Analytical procedure lifecycle management (APLM) provides flexible solutions for quantification challenges. The approach is based on the alignment of data uncertainties and an organization's tolerance for risk. APLM can be used to transparently manage an analytical procedure or method from selection, fit-for-purpose validation/verification, and performance monitoring via control charting, through changes and improvements made to the procedure, ending with termination of use. This presentation will provide an overview of APLM and give examples of how the information and data gathered through its application will help those tasked with managing, maintaining, and improving the quality of analytical procedures, quantification data, and probiotic products.
