Podcast - OSO BioPharmaceuticals Kimberly K. Ray
Podcast - OSO BioPharmaceuticals Kimberly K. Ray
Kimberly K. Ray
Sr. Manager, Project Management,
OSO BioPharmaceuticals
With an increasing focus on containment for pharmaceutical manufacturing, active pharmaceutical ingredients (APIs) are becoming more targeted, hence more potent. Environmental, health and safety (EHS) groups push for the use of engineering controls, but the implementation of RABS and isolation technology may be an ideal solution for some pharmaceutical manufacturers; however it may not be the most efficient processing option, or the most cost effective. A risk-based approach to containment offers some alternatives. We will discuss how Oso BioPharmaceuticals has successfully implemented scientific, risk-based approach to handling hazardous compounds, how it has impacted their clients, and the reaction of regulatory bodies. OsoBio will share how implementation of this approach has affected its business as well as its processes.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As 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.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As 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.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
