Search results for " antibody"
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FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance …
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
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Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
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Antibody Fragments and Their Purification by Protein L Affinity Chromatography
Antibodies and related proteins comprise one of the largest and fastest-growing classes of protein pharmaceuticals. A majority of such molecules are monoclonal antibodies; however, many new entities…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
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Guide for selecting affinity resins for mAbs, bsAbs, and antibody fragments
Development of antibody-derived molecules are increasing. Today, molecules such as bispecific antibody (bsAb) and antibody fragments such as Fab, scFv, and VHH are seen in labs all over the w…
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eBook: Purification of Antibody Therapeutics - Approach for Diversified Pipeline
Antibody therapeutics are the largest class of biotherapeutics. Over the years, development beyond traditional monoclonal antibodies (mAbs) has increased. Today, we see multispecific and bispe…
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USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
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Chromatography innovations for the diversified antibody pipeline
Introducing MabSelect™ VH3 affinity resin for antibody variants
At Cytiva, we connect with process developers and manufacturers to understand their needs and strive to make t…
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Optimization of a two-step purification method for bispecific antibodies
Bispecific antibodies (bsAbs) have gained increasing interest over recent years because they can bind two antigens, offering unique modes of action compared to monoclonal antibodies. New and i…