Search results for " monoclonality" 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
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 solution (mAb-A; IgG1) u…

Article Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria. By Anurag S. Rathore, Jyot…

Article Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…

Article Elucidating Biosimilars Characterization
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …

Article Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015 By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell BioPharm International Volume 3, Issue 28 In the past two decades, Protein A affinity chromatography ha…

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

Article Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…

Article Best Practices for Selecting a Top-Quality Cell Line
Added to this challenge is the strong focus by regulatory authorities on monoclonality, according to Collins. “Whichever method is used for clonal selection should be well validated and ideally utiliz…

Article Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…

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