BIOPHARMA WORKFLOW SOLUTIONS - Drug Development and Quality Control

Význam tématu

In modern biopharmaceutical research and quality control, laboratories must handle an ever-growing volume of complex samples under tight timelines. Integrated analytical workflows—from raw material characterization through sample preparation to final protein and glycan analysis—are critical for ensuring high throughput, reproducibility, and regulatory compliance.

Cíle a přehled studie / článku

This whitepaper presents Agilent’s end-to-end biopharma analytical solutions. It aims to illustrate how advanced instrumentation, robust separations, and automation jointly resolve complex analytical challenges in monoclonal antibody (mAb) development, clone screening, method transfers, and QC environments.

Použitá metodika a instrumentace

Agilent’s integrated platform includes:

• Bio-inert 1260 Infinity II LC system for metal-free HIC and reversed-phase separations under harsh conditions
• 1290 Infinity II UHPLC with Flexible Pump (up to 1300 bar) for sub-5-minute protein fragment runs
• Ready-to-go 2D-LC solutions with heart-cutting and comprehensive modes for impurity analysis
• AssayMAP automated sample prep for affinity enrichment, digestion, desalting, and glycan mapping
• Accurate-mass TOF and Q-TOF LC/MS platforms (6500 Series, 6550 iFunnel) for intact mass, PTM, and peptide mapping
• Buffer Advisor software for automated pH and salt gradient creation
• Capillary electrophoresis (CE) and CE/MS for charge variant, glycan, and peptide analyses
• 2100 Bioanalyzer and 4200 TapeStation for protein and nucleic acid QC
• ICP-MS and UHPLC methods for elemental impurity, amino acid, and raw material analysis

Hlavní výsledky a diskuse

Key performance gains include:

• Elimination of system-derived artefacts via fully bio-inert flow paths
• Ultra-fast separations: mAb fragments in <5 min, glycans in <10 min
• 20–50 % run-time reduction through automated offline column regeneration and method scouting
• Simplified 2D-LC setup with a single user interface and seamless peak parking
• High reproducibility and throughput through AssayMAP robotics in multi-step sample prep
• Enhanced mass deconvolution (pMod) delivering clean spectra, precise mass assignments, and reliable PTM identification
• Mirror-plot tools for rapid batch-to-batch and biosimilarity comparisons
• CE/MS solutions offering high efficiency for glycan and charge heterogeneity assessments

Přínosy a praktické využití metody

Laboratories benefit from:

• Accelerated clone screening, method transfer, and stability testing workflows
• Seamless scaling from R&D to manufacturing and QA/QC with standardized consumables
• Automated, walkup access enabling non-expert users to generate reliable LC and LC/MS data
• Comprehensive characterization (intact proteins, fragments, peptides, glycans, charge variants) on unified platforms
• Improved decision making through automated reporting and data visualization

Budoucí trendy a možnosti využití

Emerging trends include:

• AI-driven method development and predictive maintenance for continuous optimization
• Real-time, in-line process analytics (PAT) for bioprocess monitoring
• Expansion of microfluidic and label-free detection techniques
• Wider adoption of 2D-LC and CE/MS in regulated biopharma laboratories
• Cloud-based informatics for multi-site data sharing and harmonization

Závěr

Agilent’s holistic biopharma workflow solutions integrate high-performance separations, accurate-mass spectrometry, and robust automation to streamline drug development and QC. These technologies deliver faster turnaround, higher data quality, and improved operational efficiency.

Reference

• Agilent Technologies. Biopharma Workflow Solutions Whitepaper, Document Number 5991-5235EN, 2017.