AUGUST 2022LIFE SCIENCES REVIEW8IN MY OPINIONIntroductionDevelopment 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 human body. The drug component of a combination product basically adds additional chemical variables to the medical device profile, and this requires risk assessment and planning. A range of systematic biological tests needs to be completed, as outlined in ISO 10993 Biological Evaluation of Medical Devices, not only on the device constituent part of ANALYTICAL CONSIDERATIONS FOR COMBINATION PRODUCTSBy Jennifer L. Riter, Sr. Director, Analytical Services, West Pharmaceutical Services, Inc.the combination product itself, but also on other constituent parts as relevant, such as the primary containment components. Testing may include in-process materials and processing aids that come in contact with the drug or device constituent parts, or combination product as a whole, during production, to control against negative safety or performance impacts. Extractables and Leachables AnalysisExtractables, as defined in USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems, are organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system and into an extraction solvent under laboratory conditions. Extractables themselves, or substances derived from extractables, have the potential to leach into the drug product under normal conditions and thus become leachables. Therefore, Jennifer L. Riter
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