Industrialization of mAb production technology: The bioprocessing industry at a crossroads
By Brian Kelley. mAbs, 2009
659 citations recorded by the source corpus.
Manufacturing processes for therapeutic monoclonal antibodies (mAbs) have evolved tremendously since the first licensed mAb product (OKT3) in 1986. The rapid growth in product demand for mAbs triggered parallel efforts to increase production capacity through construction of large bulk manufacturing plants as well as improvements in cell culture processes to raise product titers. This combination has led to an excess of manufacturing capacity, and together with improvements in conventional purification technologies, promises nearly unlimited production capacity in the foreseeable future. The increase in titers has also led to a marked reduction in production costs, which could then become a relatively small fraction of sales price for future products which are sold at prices at or near current levels. The reduction of capacity and cost pressures for current state-of-the-art bulk production processes may shift the focus of process development efforts and have important implications for both plant design and product development strategies for both biopharmaceutical and contract manufacturing companies.
Subfields: Molecular Biology, Radiology, Nuclear Medicine and Imaging
View Paper: https://www.semanticscholar.org/paper/64a1d6e69cf0f4b82549c6e514e30f00595e8d53
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In Molecular Biology
In Radiology, Nuclear Medicine and Imaging
Citations in the corpus
- Therapeutic antibodies for autoimmunity and inflammation (2010, background): “, as well as advances in the industrialization of recombinant antibody production and purification processe”
- Cell culture processes for monoclonal antibody production (2010, background): “Today, the combination of high titers and large capacity has gradually shifted the focus of cell culture process development from pursing even higher titers to controlling product quality and process consistency at all development stages and production scales.(3) Cell culture process development sta”