Search results for " monoclonal"
Article
Re-use of Protein A Resin: Fouling and Economics
Bracewell
BioPharm International
Volume 3, Issue 28
In the past two decades, Protein A affinity chromatography has remained the de facto capture step for purification of monoclonal antibod…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Coffman, Christopher Gallo, and Ranga Godavarti
ABSTRACT
In recent years, most pharmaceutical companies have focused on the development of monoclonal antibodies (mAbs). Increasing upstream t…
Article
Digitalization: The Route to Biopharma 4.0
Side-by-side Comparability of Batch and Continuous Downstream for the Purification of Monoclonal Antibodies. Biotechnol. Bioeng. 2020, 117 (4), 1024–1036.
19. Fisher, A. C.; Kamga, M. H.; Agarab…
Article
Best Practices for Selecting a Top-Quality Cell Line
Before scaling up to bioreactors, the productivity level for monoclonal antibodies (mAbs) should be 2–7 g/L (fed-batch culture in shake flask) or greater, observes Selexis CEO Igor Fisch. Once scaled …
Article
Preclinical Evaluation of Product Related Impurities and Variants
Two case studies—one involving a microbial therapeutic product (granulocyte colony stimulating factor)—and other—a mammalian therapeutic monoclonal antibody (bevacizumab) have been used to illustrate …
Article
Continuous Processing for the Production of Biopharmaceuticals
In recent years, there have been publications reporting development of a fully integrated end-to-end commercial continuous process for the manufacturing of recombinant monoclonal antibodies (5).
T…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
By Anna Grönberg
An important area of focus for the biopharma industry is the elucidation and development of robust, efficient, and economic purification strategies for new monoclonal antibodies (…
Article
Quality by design for biotechnology products—part 1
Understanding the structure and functional attributes of therapeutic proteins, including monoclonal antibodies (MAbs), is key to developing the design space, because that understanding facilitates the…
Article
Modeling the Degradation of mAb Therapeutics
This is particularly true for monoclonal antibodies (mAbs), which account for most commercial biopharmaceuticals today. Both physical effects such as aggregation and chemical modifications (e.g., frag…
Article
Scaling Up Novel Therapies
Used almost exclusively for monoclonal antibodies (mAbs), platforms help shorten development times, particularly early in development, Ransohoff says. They also allow manufacturers to leverage perform…