R Jacquemart, M Vandersluis, M Zhao… - Computational and …, 2016 - Elsevier
The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices …
EK Read, JT Park, RB Shah, BS Riley… - Biotechnology and …, 2010 - Wiley Online Library
Process analytical technology (PAT) has been gaining momentum in the biotech community due to the potential for continuous real‐time quality assurance resulting in improved …
ME Rodrigues, AR Costa, M Henriques… - Biotechnology …, 2010 - Wiley Online Library
Monoclonal antibodies (mAbs) have become vitally important to modern medicine and are currently one of the major biopharmaceutical products in development. However, the high …
J Gaudreault, C Forest-Nault, G De Crescenzo… - Processes, 2021 - mdpi.com
Biomanufacturers are being incited by regulatory agencies to transition from a quality by testing framework, where they extensively test their product after their production, to more of …
J Kastenhofer, V Rajamanickam… - Journal of …, 2021 - Elsevier
Soluble expression of recombinant proteins in E. coli is often done by translocation of the product across the inner membrane (IM) into the periplasm, where it is retained by the outer …
P Thillaivinayagalingam, J Gommeaux… - … of Chromatography B, 2010 - Elsevier
Surface plasmon resonance (SPR) permits the quantitative analysis of therapeutic antibody concentrations and impurities including bacteria, Protein A, Protein G and small molecule …
N Chavane, R Jacquemart, CD Hoemann… - Analytical …, 2008 - Elsevier
We report an innovative at-line method to monitor concentration of bioactive antibody (ie, antibody with conserved antigen-binding activity) secreted during bioreactor culture by the …
Online and non‐invasive quantification of critical tissue engineering (TE) construct quality attributes in TE bioreactors is indispensable for the cost‐effective up‐scaling and automation …
L Durous, T Julien, B Padey, A Traversier… - Vaccine, 2019 - Elsevier
Influenza vaccine manufacturers lack tools, whatever the involved production bioprocess (egg or cell-based), to precisely and accurately evaluate vaccine antigen content from …