“The most sensitive and robust Host Cell Protein analysis we’ve seen”

Analyses of key protein features, stability and impurity levels

This client uses Alphalyse’s host cell protein analysis services on an ongoing basis to optimize their process development, product quality and process-related impurities. As a result, they stay in the frontline of inhalation therapy.

The North American-based company develops novel inhalation therapies for the treatment of patients with rare pulmonary conditions. The lead products are in phase 3 development and planned to be on the market within the next year.

In short, the analytical services include detailed characterization of biologic samples by intact mass analysis and peptide mapping, performed by Alphalyse. Additional focus is on the downstream process for batch-to-batch comparability and for process optimization. Specifically, process-related impurities are identified and quantified through the unique Alphalyse Host Cell Protein analysis using SWATH LC-MS technology.

The collaboration is highly beneficial for both companies: The client is particularly interested in innovative approaches for protein analysis, as they know it saves them time and money in the long run. Similarly, Alphalyse benefits from their feedback to optimize and further develop sensitive mass spectrometry techniques.

US biotech company_logo
"To assist our process optimization, Alphalyse developed an LC-MS method for intact mass determination of the drug product and product-related impurities. The method could separate the drug product from impurities in all process samples, and is the most sensitive, yet robust HCP analysis we’ve seen. "

US biotech company- Sr. Director, Pharmaceutical Development

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