[PDF][PDF] Viral clearance for biopharmaceutical downstream processes
AA Shukla, H Aranha - Pharmaceutical Bioprocessing, 2015 - academia.edu
Viral clearance studies are mandated prior to entering clinical trials and for commercial
launch of biopharmaceuticals. These studies are a key component of risk mitigation to …
launch of biopharmaceuticals. These studies are a key component of risk mitigation to …
Effectiveness of mouse minute virus inactivation by high temperature short time treatment technology: a statistical assessment
M Murphy, GM Quesada, D Chen - Biologicals, 2011 - Elsevier
Viral contamination of mammalian cell cultures in GMP manufacturing facility represents a
serious safety threat to biopharmaceutical industry. Such adverse events usually require …
serious safety threat to biopharmaceutical industry. Such adverse events usually require …
Viral adventitious agent detection using laser force cytology: Intrinsic cell property changes with infection and comparison to in vitro testing
PR Hayes, TM Przybycien… - Biotechnology and …, 2022 - Wiley Online Library
Adventitious agent testing in biomanufacturing requires assays of broad detection capability
to screen for as many infectious agents as possible. The current gold standard for general …
to screen for as many infectious agents as possible. The current gold standard for general …
Safety assurance for biologics manufactured in mammalian cell cultures: a multitiered strategy
D Chen - Mammalian cell cultures for biologics manufacturing, 2014 - Springer
Contamination by viral and microbial agents is a serious risk for biopharmaceuticals
produced by mammalian cell culture processes. In order to effectively mitigate the risk and …
produced by mammalian cell culture processes. In order to effectively mitigate the risk and …
Challenge of adventitious agent control
J Geigert, J Geigert - The Challenge of CMC Regulatory Compliance for …, 2013 - Springer
The primary adventitious agents of concern for biologics are examined in detail—prions,
viruses, mycoplasmas, and bacteria/fungi microbes. The three major risk control procedures …
viruses, mycoplasmas, and bacteria/fungi microbes. The three major risk control procedures …
[PDF][PDF] Engineering MVM Resistance in CHO Cells
J Mascarenhas, T Borgschulte… - BioProcessing, 2017 - bioprocessingjournal.com
Introduction For decades, Chinese hamster ovary (CHO) cells have proven to be
indispensable for the biopharmaceutical manufacturing industry, serving as cell factories …
indispensable for the biopharmaceutical manufacturing industry, serving as cell factories …
Оценка эффективности удаления и инактивации вирусов в модельном процессе производства биотехнологического лекарственного препарата на основе …
РА Вассарайс, СГ Юрков, СП Живодеров… - Биотехнология, 2021 - elibrary.ru
Обеспечение вирусной безопасности при разработке производственного процесса
получения биотехнологических лекарственных препаратов на основе клеточных линий …
получения биотехнологических лекарственных препаратов на основе клеточных линий …
[CITATION][C] Evaluation of the Virus Elimination and Inactivation at Different States of the Model Biotechnological Process for the Production of a Drug Based on the …
RA Vassarays, SG Yurkov, SP Zhivoderov, AY Koltsov… - Biotekhnologiya, 2021