Search results for " antibody production"
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Antibody Production Workflow
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Antibody-based therapies have evolved beyond monoclonal antibodies (mAbs) to include bispecific antibodies, antibody fragments, antibody-drug conjugates (ADCs), and m…
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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…
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A Platform Approach for the Purification of Domain Antibodies (Dabs)
This Application note describes a three-step purification process of a domain antibody (Dab) expressed in the periplasm of E. coli. First, a capture step using Capto™ L was used to reduce E. coli host…
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Late stage failures of monoclonal antibodies
Despite the significant developments that have happened in clinical trial design and the considerable experience that the biopharma industry has gained in the past three decades, therapeutic…
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Bispecific Antibody Purification: Insights and Case Studies
New modalities, like bispecific antibodies, present unique challenges compared to mAb production. For purification, there’s not just one right answer to which strategy to use. Here are some industry…
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Single-Use Workflow for Recovery of a Domain Antibody from E. coli Culture Feed in an Automated Manner
This application note demonstrates the performance of the automated ÄKTA™ readyflux single-use filtration system in microfiltration applications. Here, a domain antibody (dAb) expressed in E. col…
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Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
Critical quality attributes (CQAs) are fundamental to regulatory compliance. CQAs typically include data on how the candidate interacts with target proteins, as well as process-related CQAs such as pr…
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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 …
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…