Search results for " monoclonality"
Resource
The Development of Therapeutic Monoclonal Antibody Products
This report provides a roadmap for the development of a monoclonal antibody product from initial discovery through the filing of an Investigational New Drug Application (IND) or Investigational Medi…
Article
High-concentration monoclonal antibody drugs: manufacturing challenges
The growth in the formulation of drugs suitable for delivery by subcutaneous (Sub-C) injection highlights manufacturing challenges associated with the higher concentration of active ingredient…
Resource
Protein A Fiber Chromatography from Research to Scale-up and Manufacturing of Monoclonal Antibodies
The new Protein A fiber chromatography format allows for quick purification of many samples because of its short cycle times. This makes the pre-packed, small-scale Protein A fiber unit a versatile …
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…
Poster
Continuous chromatography in downstream processing of a monoclonal antibody
In this study, periodic counter current (PCC) chromatography and straight-through processing (STP) technologies were evaluated in a continuous three-step monclonal antibody (MAb) purification proces…
Poster
Purification of monoclonal antibodies using modern chromatography media and membranes
This white paper is a guide to the development of MAb purification platforms and provides an overview of Cytiva’s offering of process chromatography media (resins) and membranes for MAb purification…
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 …