175 CDER-Registered Facilities in Katrina Disaster Area
Pharmaceutical Technology has cross-referenced a list of zip codes for FEMA-designated Gulf Coast disaster areas with a database of manufacturing facilities registered with the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER).
The comparison yielded a list of 175 facilities operated by 120 organizations. Of these facilities, 92 were in Louisiana, 65 in Mississippi, and 18 in Alabama.
Most of the locations are operated by medical gas producers (49) or providers (60, typically regional health chains, home health agencies, respiratory therapy companies, and medical supply houses).
Of the remainder, only a handful could be identified as fine chemical producers (11) or pharmaceutical companies or contract manufacturers (12).
Despite the widespread damage and flooding, some facilities, especially those at the edges of the disaster area, remain in operation.
–Douglas McCormick
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.