Search Results for: antibody characterization

Mitigate Risk with Effector Function Characterization for Antibody Therapeutics

The complexities of biomanufacturing combined with heterogeneity introduced by cellular expression systems present significant challenges to assessing the quality of biologics such as monoclonal antibodies (MAbs). Information related to the critical quality attributes (CQAs) of MAb drug candidates is unknown during early phase drug development. It must be established empirically by physical, structural, and functional analyses as early as possible to accelerate development and mitigate risk through greater understanding of product characteristics. High-resolution analytical techniques are required to answer questions…

Characterization and Lot Release Assays for Antibody Drug Conjugates

Antibody-drug conjugates (ADCs) add an additional level of challenge to testing of biotherapeutics. Besides the antibody, which needs to be evaluated for potential and known mechanisms of action (MoA), there is a cytostatic compound conjugated that alters the behavior of the antibody-vehicle within the typical assays. Therefore, characterization of new innovators as well as biosimilarity assessment is even more challenging than it is for antibody therapeutics. Using the example of Trastuzumab emtansine, Charles River has set up a panel of…

Uniting Small-Molecule and Biologic Drug Perspectives: Analytical Characterization and Regulatory Considerations for Antibody–Drug Conjugates

Cosponsored by CASSS (an international separation science society) and the US Food and Drug Administration (FDA), the January 2010 CMC Strategy Forum explored antibody–drug conjugates (ADCs), which are monoclonal antibodies (MAbs) coupled to cytotoxic agents. The ADC platform of products is being used more and more for clinical evaluation in oncology. More than a dozen companies are developing several types, including products conjugated with calicheamicin, auristatins, and maytansinoids. Such products use the specificity of a MAb to deliver a cytotoxic…

Antibody and Protein Therapeutic Kinetic Characterization in Bioprocessing

Figure 1. There are a variety of affinity tag-protein strategies, and the use of affinity tags depends on the target protein, the expression system, and the application. The Octet QK and Octet RED systems provide an easy-to-use, label-free, high-throughput system to capture affinity-tagged biologics for quantitative or kinetic biomolecular interaction analysis. Kinetic characterization of biologics during clone selection, screening, and development is critical at all stages of therapeutic engineering and bioprocessing. Key Applications Quantitative kinetic characterization (kobs′ ka′ kd′ KD…

Cell-Line Development: Accelerating Antibody Discovery By Monitoring Titer and Glycosylation with the Octet Platform

Cell line development involves the screening of thousands of clones in an effort to find the few optimal clones that are stable, grow as expected, and produce high yields of the bioproduct. The time it takes from engineering an optimal cell line to the production of the target biologic can be prohibitive and may differ from molecule to molecule. While expression-level analysis like titer screening is carried out early, other critical quality attributes (CQAs) such as glycan characterization are often…

SARS-CoV-2 Hyper-Immunoglobulin: Purification and Characterization from Human Convalescent Plasma

The novel severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) emerged as a major pandemic coronavirus disease in 2019 (COVID-19) and since then has killed many people and paralyzed the global economy (1, 2). With specific antiviral therapeutic agents or antibodies yet to be approved, other antivirals and novel vaccine strategies have been essential to containing the virus and disease transmission. Passive antibody therapy can be used to limit the scope of epidemics by providing patients with antibodies that recognize…

Your Guide to Efficiently Develop Antibody-Based Therapeutics

This eBook presents various techniques used to measure the stability of antibody-based biotherapeutics. The authors address the ins-and-outs of monoclonal antibody (MAb) formulation, cover Investigational New Drug (IND) and New Drug Application (NDA) filing timelines, and explain how storage conditions affect MAb stability. Monoclonal antibodies have been used in therapeutics for more than 30 years. Efforts to further develop and optimize better MAb-based biotherapeutics are increasing as they have become increasingly popular for the treatment and prevention of many diseases…

Antibody Internalization: Advanced Flow Cytometry and Live-Cell Analysis Give Rich Insights During Antibody Profiling

The natural characteristics of antibodies, such as high binding affinity, specificity to a wide variety of targets, and good stability, make them ideal therapeutic candidates for many diseases. Therapeutic antibodies, in particular monoclonal antibodies (mAbs), deliver promising therapeutic results in several different disease areas, such as autoimmunity, oncology, and chronic inflammation. Researchers’ abilities to improve the breadth of antibodies have been aided by innovative technologies for antibody discovery, for instance, through humanization of mouse antibodies and phage display. However, advanced…

Challenges Of Host Cell Protein Analysis With ELISA And How To Obtain Better Coverage Of Your ELISA Antibody Reagents

Why is host cell protein (HCP) detection and removal so critical when manufacturing biologics? Product purity and, most importantly, patient safety depends on it. Sandwich ELISA has been a favored method for HCP testing due to its high sensitivity and high throughput, but challenges and limitations exist. Coverage depends strongly on the use of antibody reagents that adequately detect and capture HCPs. In this webinar, we address effective techniques for both optimizing HCP ELISA coverage through the selection of reagents…

Identification of Host Cell Protein (HCP) Impurities using Antibody Affinity Extraction and Mass Spectrometry Approach

This webcast features: Eric Bishop, Vice President of Research & Development, Cygnus Technologies A well-developed, broadly reactive, and qualified HCP ELISA remains a gold standard method effectively used during the purification process to ensure removal of HCP and to demonstrate process consistency and final drug substance purity. Unfortunately, the ELISA does not inform which HCPs are present or to which HCPs the assay reacts. Mass Spectrometry (MS) is a powerful tool for identifying those HCPs that persist through downstream purification…