waters_connect for biopharmaceuticals
Accelerating biopharmaceutical analysis
The efficient analysis of complex modern biotherapeutics and vaccines requires effective and integrated workflows for the acquisition, processing, reviewing, and reporting of data and results. These analyses occur on multiple levels: the intact molecule, protein subunits, digested peptides, and labeled released glycans.
waters_connect for biopharmaceuticals provides the compliant-ready, networked informatics platform and streamlined biopharmaceutical workflows to unite LC-MS systems across an organization. From product and process characterization to more targeted attribute monitoring and release assays, the journey from sample to actionable result has never been faster or more assured.
waters_connect for biopharmaceuticals
Overview
- Address your attribute characterization and attribute monitoring challenges using app-based integrated workflows
- Streamline data acquisition, processing, review, and reporting with complete workflow solutions to maximize ease of use and accelerate decision making
- Reduce time to results and increase flexibility when screening large numbers of biomolecules, including RNA molecules, synthetic peptides, and synthetic oligonucleotides
- Routinely monitor biopharmaceutical protein product quality attributes (PQAs) at the peptide level and identify unexpected peaks with New Peak Detection (NPD)
- Unite product and process characterization with monitoring and release assays using a single compliant-ready software solution
Recommended Use: Ideal biopharmaceutical LC-MS applications for analytical workflows like protein-based therapeutics, vaccines, and nucleic acid-based therapeutics.
Features Header
Modern compliant-ready networked architecture
waters_connect for biopharmaceuticals has been fundamentally designed to support networked access to your systems and data for efficient operations and management.
- Networked interface supports a mix of quadrupole time-of-flight (QTof) and BioAccord Systems
- Controlled access to your data in your lab, office, or other networked locations
- Industry-leading compliance tools and professional services and support
- API interface and export tools for third-party software interaction
Dedicated biopharmaceutical application workflows
waters_connect has app-based integrated workflows ready to address your attribute characterization and attribute-monitoring challenges, like:
- Intact mass analysis (proteins, subunits, nucleic acids, or peptides)
- Peptide mapping by data-dependent acquisition (DDA)and MSE-based data-independent acquisition (DIA)
- Peptide multi-attribute method (MAM)
- Released N-glycan analysis (fluorescence (FLR)/MS)
- Cell culture media analysis
- Oligonucleotide Mapping
Intact mass analysis
Intact mass analysis of traditional and emerging biotherapeutic modalities allows users to:
- Streamline mass confirmation and purity determination of biomolecules, including proteins, peptides, oligonucleotides, and conjugates
- Assess the critical attributes of sgRNA and mRNA molecules
- Increase their laboratory’s capacity for Intact Mass analysis with intelligent automated deconvolution
- Reduce time to result and increase flexibility with automated acquisition and processing
- Utilize the universal BayesSpray algorithm or widely used average mass MaxEnt1 deconvolution algorithms
- Support both MS- and UV-based quantification of impurities and impurity identification
- Support high-capacity, high-throughput mass confirmation and purity determination of hundreds of unique biomolecules per day
Released N-glycan analysis
The released N-glycan workflow automates analysis, processing, and reporting of labelled N-glycan profiles using FLR- and MS-based detection features:
- Automated alignment of FLR and MS chromatograms
- Dextran calibration for normalized retention time glucose unit(GU)-based assignment
- Glycan GU libraries for 2-AB, 2AA, and RapiFluor-MS-labelled glycans
- Ability to create custom GU libraries for your molecule
- FLR quantification with accurate mass confirmation
Peptide mapping
The peptide mapping workflow automates the analysis of digested protein-based therapeutics by MS, DDA MS/MS, and DIA MSE-based acquisition and enables:
- Peptide identification based on accurate mass and fragment confirmation
- Sequence coverage at peptide and fragment levels
- Assignment of protein modifications and calculation of % modification levels
- Collecting m/z, retention time, and charge state response information to build libraries for targeted analysis by Peptide MAM
Peptide MAM
The waters_connect Peptide MAM application provides an automated workflow for product quality attribute monitoring, ID confirmation, and new peak detection-based purity assays with which users can:
- Integrate data acquisition, system suitability, data review, and reporting with a simple graphical workflow design for efficient data review
- Populate the targeted attribute list directly from the waters_connect scientific library, import file, or via manual entry
- Avoid missed peaks and improve quantification with advanced RT alignment tools
- Enhance productivity with robust new peak detection of potential impurities, providing high sensitivity with low false positive detection rates
RNA Oligo Mapping
The MAP Sequence App is a purpose-built waters_connect application to accelerate the characterization of larger RNA molecules (e.g. sgRNA and mRNA) by processing of data generated from enzymatically digested RNA LC-MS Maps, allowing users to:
- Streamline RNA sequence confirmation and impurity characterization.
- Perform oligo mapping analysis of RNA molecules containing modified bases and linkages.
- Analyze oligo maps with the flexibility to employ traditional RNAase digestion enzymes (e.g. RNAase T1) and the expanding toolset of RNA digestion enzymes with alternative digest specificities, to obtain maximum sequence coverage.
- Reduce time spent on data interrogation with unique data visualization tools and streamlined data review features that focus the user on regions with potentially ambiguous results.
Oligonucleotide sequencing
The CONFIRM Sequence application is the first purpose-built workflow to accelerate the characterization of synthetic oligonucleotides and digested RNA fragments, allowing users to:
- Streamline nucleic acid sequence confirmation and impurity characterization with a dedicated workflow
- Improve analytical efficiency with rapid analysis and calculation of sequence coverage from multiple targeted (MS/MS) or untargeted (MSE) experiments
- Increase confidence in results with automated modification localization
- Reduce time spent on data interrogation with unique data visualization tools and comprehensive raw data review features
- Maintain regulatory requirements with the compliant-ready waters_connect platform
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