Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins
H Broly, J Souquet, A Beck - MAbs, 2023 - Taylor & Francis
The COVID-19 pandemic highlighted the urgent need for life-saving treatments, including
vaccines, drugs, and therapeutic antibodies, delivered at unprecedented speed. During this …
vaccines, drugs, and therapeutic antibodies, delivered at unprecedented speed. During this …
Application of machine learning methods to pathogen safety evaluation in biological manufacturing processes
The production of recombinant therapeutic proteins from animal or human cell lines entails
the risk of endogenous viral contamination from cell substrates and adventitious agents from …
the risk of endogenous viral contamination from cell substrates and adventitious agents from …
Removal of minute virus of mice-mock virus particles by nanofiltration of culture growth medium supplemented with 10% human platelet lysate
L Barro, L Delila, O Nebie, YW Wu, F Knutson… - Cytotherapy, 2021 - Elsevier
Abstract Background aims Platelet concentrates (PCs) are pooled to prepare human platelet
lysate (HPL) supplements of growth media to expand primary human cells for …
lysate (HPL) supplements of growth media to expand primary human cells for …
Surrogate model to screen for inactivation‐based clearance of enveloped viruses during biotherapeutics process development
Viral surrogates to screen for virus inactivation (VI) can be a faster, cheaper and safer
alternative to third‐party testing of pathogenic BSL2 (Biosafety level 2) model viruses …
alternative to third‐party testing of pathogenic BSL2 (Biosafety level 2) model viruses …
Suitability of a generic virus safety evaluation for monoclonal antibody investigational new drug applications
P Sipple, T Nguyen, K Patel, N Jaffe… - Biotechnology …, 2019 - Wiley Online Library
Biologics produced from CHO cell lines with endogenous virus DNA can produce retrovirus‐
like particles in cell culture at high titers, and other adventitious viruses can find their way …
like particles in cell culture at high titers, and other adventitious viruses can find their way …
Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding
D Roush, J Blümel - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
This article describes a summary of discussions and outcomes from the 2019 Viral
Clearance Symposium Session 4 on the utilization of knowledge, both from within and …
Clearance Symposium Session 4 on the utilization of knowledge, both from within and …
Proceedings of the 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies
S Reitz, A Schwantes - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
Session 1 of the 2019 Viral Clearance Symposium proposed strategies to use prior
knowledge for demonstrating robust viral clearance for biotechnologically produced …
knowledge for demonstrating robust viral clearance for biotechnologically produced …
A direct RT qPCR method for quantification of retrovirus-like particles in biopharmaceutical production with CHO cells
M Hussain, WJ Rayfield, DJ Roush - Journal of Pharmaceutical and …, 2020 - Elsevier
Chinese hamster ovary (CHO) cells are the host cell of choice for manufacturing biologic
drugs, like monoclonal antibody, in the biopharmaceutical industry. Retrovirus-like particles …
drugs, like monoclonal antibody, in the biopharmaceutical industry. Retrovirus-like particles …