Search results for "antibodies"
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FDA Provides Guidance on Bispecific Antibody Development Programs
FDA published final guidance on May 24, 2021 to provide industry and stakeholders with recommendations for the development of bispecific antibodies including recommendations for regulatory, quality, n…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Biotech therapeutics, particularly complex products such as monoclonal antibodies (mAbs), can have numerous quality attributes that can potentially impact safety and/or efficacy of the product (2). Id…
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Evolution of the Monoclonal Antibody Purification Platform
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline, as well as revenue, of major biopharmaceutical companies (1). What is unique about mAbs from a processing pers…
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Antibody Fragments and Their Purification by Protein L Affinity Chromatography
A majority of such molecules are monoclonal antibodies; however, many new entities are antibody fragments. Due to their structural, physiological, and pharmacological properties, antibody fragments of…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
Three recombinant Chinese hamster ovary (CHO) cell lines, developed in-house to produce three different monoclonal antibodies, were used in this study. Cell lines A and B are dihydrofolate reductase-d…
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eBook: Purification of Antibody Therapeutics - Approach for Diversified Pipeline
Over the years, development beyond traditional monoclonal antibodies (mAbs) has increased. Today, we see multispecific and bispecific antibodies, antibody fragments, and antibody drug conjugates in th…
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USP Publishes Monoclonal Antibody Guidelines
…ells, cell killing, cross-linked induced apoptosis, antagonism against several targets, and agonist antibodies. Because of structural similarities between antibodies of the same class, the United Sta…
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Chromatography innovations for the diversified antibody pipeline
MabSelect™ VH3 resins provides efficiency in capture of bispecific antibodies and antibody fragments such as Fab, scFv, and VHH. Discover how we’re supporting the diverse antibody pipelines with chrom…
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Optimization of a two-step purification method for bispecific antibodies
Alligator Bioscience AB develops antibody-based pharmaceuticals for cancer treatment, specializing in mono- and bispecific antibodies for tumor-directed immunotherapies. The company is active in the e…
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Selection Guide: Columns and Resins for Antibody Purification and Immunoprecipitation
Polyclonal antibodies, monoclonal antibodies (mAbs), and antibody fragments are usually purified by affinity chromatography. Resins containing an immobilized ligand (e.g., protein A, protein G, or p…