The evolving regulatory expectations for the pharmaceutical industry require early evaluation of sterile (or injectable) drug product packaging materials. Biologic drug products have seen increased growth and typically use parenteral drug packaging systems. The sensitivity of biologic/cell/gene therapy drug products drives the need to minimize the use of silicone and maximize the use of barrier films and coatings. Primary container component manufacturers have been working to improve these films and coating through multiple technologies.
Market insights of biologic/cell/gene therapy drug product sensitivities that establish the need for using barrier films and coatings.
Scientific rationale for surface barrier technologies, comparison of processes, chemistry, and characterization techniques
Case study comparison of the impact of two elastomer closures with different surface barrier technologies on a model protein, Immunoglobulin G. including differences of silicon levels and protein particle aggregation.
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