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Biotherapeutics are among the fastest-growing segments of the pharmaceutical market. The packaging requirements for these therapeutics can be unique, primarily due to the multitude of factors that can influence the stability and overall potency of each particular therapeutic. Additionally, packaging has become a prominent concern in the healthcare industry due to the prevalence of medication errors, hospital acquired infections and potential for injury to the healthcare worker. The ability to provide these therapies in ready to use (RTU) containers would provide several advantages to both patients and clinicians: the RTU systems are closed containers, which minimize the risk of hospital-acquired infections; there are no reconstitution or admixture steps required, which minimize the risk of medication errors and healthcare worker exposure; and the RTU systems save time for the clinicians. However, the decision about drug formulation and packaging often needs to be made early in development when supplies of the drug are scarce.

Assays for Assessing the Compatibility of Therapeutic Proteins with Flexible Drug Containers