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.

BioAccord LC-MS System Make better and faster decisions, maximize organizational efficiency, and directly measure multiple product quality attributes with the BioAccord LC-MS System.

Bioprocessing Accelerate biotherapeutics discovery and development timelines with Waters Process Analytical Technology (PAT) solutions for upstream and downstream bioprocessing.

Amino Acid Analysis Maximize protein yield, enhance protein manufacturing consistency and achieve accurate, high-throughput amino acid analysis with Waters sample preparation, columns, standards, lab equipment and data management solutions for amino acid testing.

Bio-conjugates Streamline the discovery and development of bio-conjugates with Waters fit-for-purpose sample preparation, columns, UPLC, MS, Light Scattering, and informatics solutions.

Biophysical Characterization Obtain stability and affinity with Waters direct thermodynamic solutions for biophysical applications, including lab instruments.

Biosimilars Confidently establish the comparability of biosimilar drug candidates to their corresponding reference product molecules with Waters biotherapeutic lab technologies, columns and consumables designed for robust biopharmaceutical characterization.

Cell and Gene Therapies Explore Waters tools and workflows for characterizing synthetic oligonucleotides, longer nucleic acids (mRNA, ssDNA, dsDNA), viral vectors and lipid nanoparticles (LNPs).

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

Glycan Solutions Improve the quality of your glycan structure analysis results with Waters complete and easy-to-use workflows for analyzing glycans and glycoproteins.

Host Cell Protein Analysis Solutions Support patient safety with Host Cell Protein (HCP) assays to meet regulatory requirements and minimize the risk of immunogenic responses with Waters solutions for biotherapeutic analysis.

Hydrogen Deuterium Exchange – Mass Spectrometry Overcome higher order structure and protein dynamics challenges with Waters hydrogen deuterium exchange mass spectrometry (HDX-MS) analysis solutions.

Intact and Subunit Protein Analysis Solutions Evaluate protein identity, glycoforms, and modifications with intact mass and subunit mass spectrometry techniques in Waters solutions for understanding protein structures and advancing biopharmaceutical research.

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

Peptide Mapping Obtain unmatched insight for complicated protein samples with Waters lab technologies for peptide and glycopeptide mapping analysis.

Synthetic Oligonucleotide Analysis Waters tools and solutions for oligonucleotide analysis deliver leading edge performance and productivity across the analytical value stream.

Synthetic Peptide Analysis Ensure drug development and quality standards are met with Waters leading solutions for lab-scale synthetic peptides like glucagon-like peptide 1(GLP-1) purification, characterization, and monitoring.

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

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Attribute Monitoring Workflows - Infographic

Attribute monitoring workflows - connecting molecular attributes to product and process knowledge using the BioAccord System.
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Mass Detection Application eBook

This eBook contains key application notes that demonstrate the capability and performance of both the ACQUITY QDa Mass Detector and the BioAccord System with the ACQUITY RDa mass detector.
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