Waters New Technology Addresses Challenges of Protein Bioanalysis

Milford, Mass.-based Waters Corporation today introduced a new line of Waters Proteinworks Digest kits that simplify, accelerate and standardize the LC-MS quantification of proteins via the surrogate peptide approach. The kits are an ideal solution for laboratories performing protein bioanalysis at innovator and biosimilar firms, contract research organizations, disease research centers, hospitals and university medical centers. The five kits are now available immediately worldwide from Waters.

Bioanalysis with liquid chromatography (LC) and mass spectrometry (MS) determines drug concentrations in biological fluids yielding data about the time course of a drug’s action in the body.

With emphasis on the process of getting biotherapeutic proteins to patients faster, Waters continues to focus on the needs of patients and improving healthcare delivery with novel pre-analytic solutions and LC-MS instrumentation that empower laboratories to tackle the complexity and challenges of large molecule quantification.

“From our collaborations with scientists, it’s clear that a better approach to bioanalysis sample preparation is needed for therapeutic proteins. Today’s methods are fraught with variability due to a lack of standardization,” said Mike Yelle, vice president, Waters Consumable Business Unit. “Our ProteinWorks Kits simplify and standardize protein quantification workflows and shorten the time to precise and accurate results.”

The kits are also expected to allow biopharmaceutical scientists to more easily deploy methods to contract organizations as well as transfer methods from one laboratory to another.

Proteinworks Express Digest Kits contain pre-measured, lot-traceable reagents, a 96-tube flexible sample collection module and easy-to-follow protocols enabling reproducible, fast digestion and accurate, sensitive protein quantification in both immunopurified and whole, non-immunopurified plasma and serum samples. The Proteinworks product portfolio includes an optional, optimized µElution SPE kit and protocol designed to increase assay sensitivity, reduce matrix interferences, and improve LC-MS system robustness.

The high reproducibility of the Proteinworks Kits suggests that a high degree of intra- and inter-laboratory standardization is achievable, making method transfer easier and more successful, the company reports.