Understanding Pharmaceutical Flows

The grant encompasses $100,000 each from the Life Sciences Entrepreneurship Center and Berkeley SkyDeck, with SkyDeck having the option to invest an additional $100,000.

In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

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