Speakers

Luke Coxon

SaniSure

Global Product Manager Mixing

Mixed4Sure is a single-use, small volume bottle mixing platform designed to support a varied range of biopharmaceutical mixing applications. As outlined in “Excellence in Mixing for Small Volume Formulation”, SaniSure has proven mixing excellence in the following categories: characterization of shear forces, minimum mixing volume, protein adsorption and product recovery. To further enhance the versatility of Mixed4Sure, its Bottom Mount mixing performance has been analyzed in conjunction with adjuvant mixing for bioprocessing formulations.

Chemically-defined adjuvants play a crucial role in vaccine formulation by enhancing the immune response, allowing for smaller volumes of the drug to be administered while still achieving the desired therapeutic effect. One of the most commonly used adjuvants is Aluminium Phosphate (AlPO4). However, AlPO4 is insoluble, and when mixed with the bulk drug substance, it forms a suspension that quickly precipitates. As a result, rapid and effective mixing becomes essential in vaccine formulations that incorporate adjuvants, ensuring the homogeneous distribution of both the adjuvant and the protein in complexation. This ensures optimal therapeutic efficacy and stability of the final product

SaniSure have characterized the performance of the Mixed4Sure™ with a mixture of surrogate protein (lysozyme), HEPES buffer and the FDA authorized maximum concentration of AlPO4. Homogeneity was determined using a turbidimeter, and mass balance was used to measure the stability of the complex.

The data presented in this talk will provide insights into the performance of the Mixed4Sure Bottom Mount to maintain an adjuvant/protein complex that can enhance the quality and consistency of filled drug product.

About Luke Coxon

Luke Coxon has been a Product Manager for SaniSure since 2021 and has global responsibility for the mixing portfolio, ensuring that the product has the necessary technical, quality and functional features that are needed by drug manufacturers. Prior to joining SaniSure he worked for Sartorius in various marketing and technical support roles and, prior to that, as an end-user implementing SUT into an Influenza manufacturing process at Novartis. Luke has worked with single-use technologies since 2006.

SaniSure

The Best Home a Drug Can Get

SaniSure is a global leader in developing and manufacturing single-use solutions for the bioprocessing industry. They offer innovative products and components for all stages of sterile manufacturing, with core manufacturing capabilities including injection molding, cleanroom assembly, tubing extrusion, injection-stretch blow molding, fabrication, and proprietary technologies.

The SaniSure single-use components provide the bioprocessing industry with high-quality, customizable products and assemblies. Their offers range from Cap2v8® Closure Systems to PharmaTainer™ Bottle Solutions and everything one may need for biomanufacturing, such as Tubing, Filling Needles, Bag Systems, and other Sanitary Components.

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