Using extractables data from single-use components for extrapolation to process equipment-related leachables: The toolbox and justifications
A Hauk, I Pahl, S Dorey, R Menzel - European Journal of Pharmaceutical …, 2021 - Elsevier
Quantitative information on process equipment-related leachables (PERLs) is required for
process qualification and within a safety assessment. Extractables data for single-use …
process qualification and within a safety assessment. Extractables data for single-use …
[HTML][HTML] Rinsing recommendations for membrane filters and identification of rinsables
R Menzel, I Pahl, T Loewe, A Stuetzer… - European Journal of …, 2022 - Elsevier
Filtration is universally used in biopharmaceutical processing. For example, in upstream
processing for sterilizing-grade filtration of cell culture media or in various downstream …
processing for sterilizing-grade filtration of cell culture media or in various downstream …
Cell and Gene Therapies: Challenges in Designing Extractables and Leachables Studies and Conducting Safety Assessments
A Arroyo, P Booij, G Woldemariam, U Bruen… - Journal of …, 2024 - Elsevier
Over the past decade, Cell and Gene Therapies (C>) have been an emerging therapeutic
area with more than twenty C> drug products approved and over 1000 registered trials. The …
area with more than twenty C> drug products approved and over 1000 registered trials. The …
Comparative extractables study of autoclavable polyethersulfone filter cartridges for sterile filtration
R Menzel, I Pahl, T Loewe, A Hauk - PDA Journal of Pharmaceutical …, 2018 - journal.pda.org
Sterile filters are ubiquitous in biopharmaceutical manufacturing processes. Because such
filters are in direct contact with the process fluid, profiling of the extractables is of utmost …
filters are in direct contact with the process fluid, profiling of the extractables is of utmost …
[CITATION][C] Extractables and Leachables in Gene and Cell Therapies
A Hauk, I Pahl, D Budde, R Menzel - Pharm. Ind, 2023