Biopharmaceutical Analysis

Organizations throughout the pharmaceutical and life sciences industry are increasing their investments in biopharmaceutical development. In this rapidly-evolving field, there is a widespread need for application-appropriate technologies. Strategic characterization technologies provide unique insights into the development potential of large molecule therapeutics. A first-line analysis of complex biotherapeutics that is rich with information can save significant time and development costs during production.

Waters' latest innovations in LC, LC/MS, and informatics are designed to address the multi-faceted analytical needs of large molecule characterization – from innovator biopharmaceuticals, to biosimilars, to antibody drug conjugates – and to keep pace with the regulatory changes that impact development laboratories.

Purpose-built LC-MS for Biopharmaceutical Analysis For biopharmaceutical organizations who need the power and performance of LC-MS for routine screening and multi-attribute monitoring (MAM), Waters has designed the first SmartMS-enabled biopharma LC-MS solution for your lab’s needs.

Amino Acid Analysis The UPLC Amino Acid Analysis Solution is a comprehensive package that combines instrumentation, chemistries, reagents, and performance-qualified methods for turn-key application success.

Antibody Drug Conjugates (ADCs) Learn about Waters' UPLC, MS detection and purpose-built informatics technologies that streamline characterization and monitoring of antibody drug conjugates (ADCs).

Biophysical Characterization of Macromolecules Techniques to complete a physicochemical approach to understanding complex solutions using higher-order structure, stability, and affinity assays.

Biosimilars Regulatory agencies have provided paths for submitting applications for biosimilars. Waters offers analytical and informatics technologies to define the innovator product and to evaluate comparability against candidate biosimilars.

DMPK: Drug Metabolism and Pharmacokinetics A portfolio of solutions to support the pharmaceutical research and development, focusing on drug metabolism and pharmacokinetics (DMPK).

Glycan Profiling Solutions Waters innovations have dramatically improved the quality, ease of use, and reduced sample prep and analysis times for glycan analysis. Waters offers complete workflow-based approaches for analyzing a glycoprotein across all structural levels.

Host Cell Proteins (HCPs) Go beyond the uncertain HCP data provided by ELISA assays to LC/MS methodologies that enable identification and quantification of host cell protein product impurities down to low ppm levels.

Hydrogen Deuterium Exchange with Mass Spec (HDX-MS) HDX-MS has applicability to answer a wide range of structural and protein dynamics questions for biotherapeutics, complexes, and protein folding/stabillity studies. Waters offers unrivaled instrumentation, chemistries, informatics, and training programs.

Intact Protein Analysis Waters technologies deliver fast and accurate intact protein mass profiles for structural confirmation and glycoform heterogeneity determination.

Mass Detection for Peptides and Glycans in Biopharma Mass detection is a powerful tool that enables complementary optical and mass analysis techniques for monitoring, quantifying, quality control of peptides, N-glycans, biologics and more

Oligonucleotide Analysis Obtain superior separations and LC/MS characterization data for synthetic oligonucleotides, from routine mass and sequence confirmation to a more detailed impurity profile analysis.

Peptide Mapping & Peptide Analysis UPLC separations and a family of optimally selective and resolving peptide separation chemistries provide unmatched resolution of complicated protein digests, exceptional glycopeptide resolution, and shorter analysis times.

Synthetic Peptide Analysis Synthetic peptides, short chains of generally less than 50 amino acids linked by amide bonds, are now one of the fastest growing market sectors in the pharmaceutical and biopharmaceutical industries.

Additional Biotherapeutic Classes and Techniques Additional classes of biotherapeutics that benefit from Waters UPLC or UPLC/MS characterization technologies.