Search results for "Protein"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
By Luhong He, Christopher Frye
Abstract
The Chinese hamster ovary (CHO) cell lines used for the production of recombinant therapeutic proteins are immortalized cells with a relatively high degre…
Article
Best Practices for Selecting a Top-Quality Cell Line
“A high-quality cell line should be well-rounded among the critical chemistry, manufacture, and control (CMC) production cell line attributes,” agrees Jill Cai, vice-president of cell and protein scie…
Article
Fermentation for the Future
Recombinant technology is used on these microbes to produce large quantities of desired substances, including peptides, proteins, and nucleic acids. Newer drug substances, such as single-domain antibo…
Article
Evolution of the Monoclonal Antibody Purification Platform
Typical steps include:
• Protein A chromatography for capture of the product and removal of host cell-related impurities (host cell proteins and DNA). Though extremely efficient and effective,…
Article
Quality by design for biotechnology products—part 1
The scope of this paper is limited to well-characterized protein products, in which the natural molecular heterogeneity, impurity profile, and potency can be defined with a high degree of confidence. …
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Ever-growing biotechnology pipelines have greatly increased demand for higher throughput, multi-product protein characterization methods. By taking a holistic approach to improving the analytical proc…
Article
A Look at the Affinity Chromatography Landscape
… affinity ligands and support systems that enable the separation and purification of not only novel protein-based biologics, but a wide range of other biomolecules, from viral vectors and nucleic aci…
Article
Improving Process-Scale Chromatography
The development of new resin chemistries including enhancements to Protein A for monoclonal antibody (mAb) capture, increasing use of automation, implementation of single-use technologies, and explora…
Article
Process Chromatography: Continuous Optimization
Host-cell proteins, host-cell DNA, other process-related contaminants, and product-related impurities (e.g., aggregates, incorrectly modified or unfolded proteins, etc.) must be removed. A combination…
Article
Antibody Production in Microbial Hosts
With more than 200 recombinant proteins on the market today, the biopharmaceutical industry is expected to reach approximately $180 billion by 2016 (1). Therapeutic mAbs and their derivatives—such as …