Why cell line screening is crucial for successul complement-dependent cytotoxicity (CDC) assay development

Highlighgt new approach to CDC Assays for mAb characterization and QC release testing 

N-Glycan Characterization with LC-MS

High level discussion of Glycosylation, Monitoring, Method Selection, and Analysis

Centralized Analytical Laboratory White Paper

Benefits of using Labcorp Biopharm CMC services to reduce risks, costs, complexities, and time of client drug development journey

Labcorp Biopharmaceutical CMC Stability Services

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Biopharmaceutical Characterization: Setting the Foundation of Success in Your Drug Development

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Biomarkers of Immunotherapy Response: Current State-of-the-Art and Emerging Trends

ACT 2024 Annual Meeting

LC-MS for improving decision making and mitigating risk in process development

CASSS MS 2024 -- Host-cell proteins (HCPs) pose a risk both to patient safety by means of immunogenic response, and to drug substance integrity by enzymatic digestion and degradation. Effective removal of the impurities while minimizing loss of the drug substance is a major challenge and milestone in the drug development life-cycle. ELISA offers excellent sensitivity for HCP content but is only able to provide total HCP abundance and is reliant on expensive polyclonal reagents. LC-MS is able to identify and quantify individual HCPs, allowing a purification strategy to be developed around known impurities using a quality-by-design approach in-line with ICH Q14. A phase-appropriate approach to HCP characterisation should be carefully considered in-line with the phase of product development for efficient process development and risk mitigation.

Formulation development to limit protein glycation

CASSS MS 2024 -- Formulation development is a crucial element of biopharmaceutical development, to maintain structural integrity whilst minimising the level of post-translational modifications (PTMs). Labcorp has developed a standardised workflow for formulation development. Following a design of experiments (DoE) study on thermally stressed pembrolizumab, a potential stability issue with glycation was identified. In this study, the effect of formulation on glycation and the effect of glycation on antigen binding were assessed in the forced degradation of lead formulations phase. The study also gave the opportunity to test the feasibility of an LC-MS multi‑attribute monitoring (MAM) method for monitoring glycation.