TECH OUTLOOK 8AUGUST - 2022IN MY OPINIONANALYTICAL CONSIDERATIONS FOR COMBINATION PRODUCTSBy Jennifer L. Riter, Sr. Director, Analytical Services, West Pharmaceutical Services, Inc.IntroductionDevelopment of combination products is increasing and with this growth in development, new and complex interactions among drug constituent parts, medical device constituent parts and related components have arisen. It is critical to understand the compatibility and performance of both the drug constituent part and the device constituent part, and of the drug-device combined use as a system.There are several areas that should be considered for analytical testing during combination product development that will be discussed in this article.Compendial Testing of ComponentsSome of the most basic aspects of qualifying delivery systems for drug products and drug-led combination products are compendial compliance of the components of the systems. Typical testing includes analysis of the materials that will be utilized in the system, such as glass, plastic, and elastomers. There are several major compendial chapters that address testing of these materials for use with parenteral injectable products such as USP <381> Elastomeric Closures for InjectionsPrimary packaging and medical device suppliers may provide compendial compliance information on their materials, components or delivery systems.Biocompatibility Testing of ComponentsCombination product biocompatibility is the analysis of a combined container closure system with a pharmaceutical drug product when in contact with, or in, the
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