Search results for " monoclonal" in Articles / App Notes
Article
Multidimensional Scale-Up of a Monoclonal Antibody Capture Step, Using ÄKTA™ pilot 600
Fast and efficient process development and scale-up contributes to a shortened time to market. In this work, a multidimensional scale-up (change of both column diameter and bed height) of a mAb capt…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Nesta
Abstract
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody sol…
Article
Antibody Production in Microbial Hosts
Rathore, Jyoti Batra
The biopharmaceutical industry is growing exponentially, driven by an ever-increasing demand for monoclonal antibodies (mAbs) and related products that are capable of treating…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Immediately following its acquisition by Pfizer, Hospira announced a major milestone in February, 2015: its first monoclonal antibody (mAb) biosimilar was approved for use in West Europe.2 And in Nove…
Article
Elucidating Biosimilars Characterization
Compare this compound with the monoclonal antibody trastuzumab, which has a reported chemical formula of C6470H10012N1726O2013S42 and a molecular weight of 145531.50 g/mol, approximately 260 times the…
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 …