At Alliance Pharma, our white papers and e-books are authored by Alliance Pharma experts to help our customers and the marketplace better understand an issue, our services, and to make informed decisions. This page will be regularly updated so please check back often for new content.
“LC-MS/MS: An Emerging Approach for Host Cell Protein Profiling"
Host cell protein (HCP) profiling is a core component of large molecule biopharmaceutical protein characterization. To ensure the safety of protein drug products, these residual impurities must be measured, monitored, and controlled to set specifications during biotherapeutic manufacturing.
Greg Kilby, Vice President of Technology and Bioanalysis at Alliance Pharma, discusses the emerging role that LC-MS/MS is playing as an orthogonal tool to help identify and quantify these impurities with exquisite sensitivity.
“Immunogenicity Testing for Biologics: Current Approaches and Emerging Application of LC-MS”
Ligand-binding assays (LBAs) are the most common methods for detection of antidrug antibodies. LBAs offer high throughput as well as excellent sensitivity and specificity; however, they also have their limitations. With advances in instrumentation, approaches using LC-MS have emerged as an adjunct tool to overcome some of the challenges associated with conventional LBAs.
The Alliance team shares perspectives on both platforms and the potential future of immunogenicity testing.
“Biologics Bioanalysis: The Advantages of Hybrid LBA/LC-MS for Antibody Drug Conjugates”
ADCs are challenging to develop and analyze for a number of reasons.
Colin Barry, VP of Technology and Bioanalysis at Alliance Pharma, shares his perspective on advantages and disadvantages of using hybrid LBA/LC-MS as a technique to overcome the challenges we face developing these unique classes of compounds.