Search results for " monoclonal"
Article
Stirring up the fermentation game
fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.
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Article
Regulatory Challenges in the QbD Paradigm
This model is especially evident in FDA's Center for Drug Evaluation and Research (CDER) as used for therapeutic biological products, such as proteins and monoclonal antibodies. These products were tr…
Article
QbD and PAT in Upstream and Downstream Processing
Some of these CQAs, such as glycoxylation pattern for monoclonal antibody (mAb) products, are primarily impacted by the upstream process and are particularly important to monitor during process develo…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“One expects that there will be minor differences in, for example, glycosylation patterns or the extent of deamination in a monoclonal antibody product. One expects that there will be slight differenc…