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.

生物製藥分析專用LC-MS 有些生物製藥組織需要借助LC-MS的功能及效能進行例行篩檢與多特性監控(MAM)，為此，Waters設計了第一套採用SmartMS技術的生物製藥LC-MS解決方案，滿足您的實驗室需求。

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.

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

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.

完整的蛋白質分析 Waters 技術可提供快速且精確的蛋白質分子量，以便您確認完整蛋白(intact proteins)及測定其醣化分子變異性。

寡核苷酸分析 使用Waters LC系統進行寡核苷酸分析，對於標靶藥物的修飾型態及其錯誤的序列可以提供更好的分離及特性描述，進而做為法定核准生物醫療使用之前的完整特性描述。

胜肽分析 UPLC胜肽分析解決方案為完善的系統方案，結合儀器及管柱，提供複雜蛋白質消化更佳的解析度、優異的醣基胜肽解析度、以及更高的通量。

胺基酸分析 UPLC胺基酸分析解決方案是一項完善的系統套組，結合了儀器及管柱，並搭配效能經過驗證的方法及整體應用支援。

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