Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.

Glycosylation is a common and critical post-translational modification that affects protein function and therapeutic efficacy, making its monitoring and accurate quantification essential for drug development.

As described in the chapter subsection USP <1207.3> Package Seal Quality Test Methods, the measurement of residual seal force (RSF) indicates the quality of the vial package seal, giving insight into the quality of the sealing process. Correlating RSF to CCI data enables optimization and validation of the vial sealing process with parameters that give assurance of good CCI. This Case Study describes how science-based statistically valid RSF data was generated on the vial sealing process and combined with CCI data to ensure good CCI of sterile product needing deep cold storage

Download this Case Study to learn how a purging process qualification study was performed using rapid non-destructive headspace oxygen analysis in an at-line set-up with samples being measured immediately from the line.

This new case study demonstrates how a non-destructive container closure integrity test method can be developed for autoinjectors with an optically transparent window.