GEN-MKT-18-7897-A
Jan 10, 2017 | Biopharma, Blogs | 0 comments
Protein-based biotherapeutics, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) are a growing component of pharmaceutical companies’ drug pipelines. The growth of ADCs in particular is due to their ability to selectivity target and deliver a potent molecule to a cancer cell based on a specific tumor marker. In order to support this growing class of new drug molecules, robust and reliable bioanalytical methods are required. While ligand binding assays (LBAs) like ELISA have been the most popular platform for biotherapeutic quantitation, bioanalytical scientists have been increasingly adopting hybrid LBA/LC-MS methods in this area.
The strengths of hybrid LC-MS assays for this application include:
For a bioanalytical scientist inexperienced in hybrid LBA/LC-MS signature peptide quantitation, the various workflows can appear complex and difficult. BioBA sample preparation kits are designed to make this complex process simple by enabling a magnetic bead-based approach to immunoaffinity sample preparation and providing all the reagents necessary (buffers, reagents, enzyme and bead) to complete the workflow.
Most ADCs are heterogeneous mixtures of species and an example is ado-trastuzumab emtansine, a lysine-linked ADC that is an approved treatment for patients with Her2+ breast cancer. The nature of the chemistry involved in lysine conjugation makes the drug product a heterogeneous mixture of species with a drug to antibody (DAR) of 0 to 8. The heterogeneous character of ADCs like adotrastuzumab emtansine require several bioanalytical assays during the drug development process. Some of these include:
Hybrid LBA/LC-MS assays can be used to address conjugated and total antibody assays by choosing an appropriate immunocapture reagent. An anti-payload antibody can be used to immunopurify and assay conjugated ADC species. To assay the total antibody, a generic anti-human Fc antibody can be employed for immunocapture, or a target-specific immunocapture strategy can be employed with recombinant target protein or an anti-idiotype antibody.
Download the tech note to see a full demonstration of a total antibody assay of ado-trastuzumab emtansine using hybrid LBA/LC-MS approach employing the BioBA sample preparation kit and a generic immunocapture strategy.
Regulated laboratories are evolving faster than ever. New analytical modalities, higher sample throughput, increasing regulatory scrutiny, and leaner teams are reshaping how work gets done. At the same time, expectations for data integrity, standardization, and operational efficiency continue to increase complexity and/or scope. In this environment, LC-MS software is no longer simply an instrument control platform—it has become a critical part of a laboratory’s quality management system. The question is no longer whether your lab has changed, but whether your software has evolved to support the way regulated labs operate today, and if they are ready and able to meet the demands, they will face tomorrow.
Analyst software has long been a trusted foundation in regulated LC-MS laboratories—and for many, it still performs reliably today. But regulated environments are evolving faster than ever. As labs transition to Windows 11, strengthen cybersecurity policies, modernize IT infrastructure, and prepare for future compliance expectations, software decisions are no longer just about what works today—they’re about managing tomorrow’s risk. Analyst will not be supported on Windows 11. While some labs may continue operating in unsupported environments temporarily, the bigger question is: when that risk becomes reality, will your lab be reacting under pressure—or executing a planned mitigation strategy with confidence?
As regulatory scrutiny increases and detection requirements tighten, laboratories are facing a new question: How can TFA be measured reliably, sensitively, and at scale?
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