Search results for " monoclonal"
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
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…