Industry guidance on container closure integrity strategies for difficult-to-test parenteral products (DTPs).

Abstract

Innovative modalities, such as antibody-drug conjugates (ADCs), radiopharmaceuticals (RPhs), and cell and gene therapies (CGTs), along with ultrahigh-concentration monoclonal antibody suspensions or high-concentration parenteral products, present unique container closure integrity (CCI) challenges because of toxicity, biohazard or radioactivity, very small batch sizes, high cost, fragility, or requirements for ultralow (<-70 °C) and cryogenic (<-150 °C) storage. These "difficult-to-test" parente