Consistency, clarity, and compliance for protein therapeutics

Successful protein programs depend on analytical consistency, clarity, and compliance built in from the start. However, quality control (QC) and development teams still struggle to deliver timely and reliable critical quality attribute (CQA) results due to fragmented workflows, rising throughput demands, and limited access to advanced analytics.​

​Waters solutions enable:​

  • Consistent performance with bioinert systems, columns, and solution-specific workflows​
  • Accelerated understanding with more accessible advanced instruments designed to support development and QC labs​
  • Compliance-ready solutions to ensure optimal data integrity​
Explore Protein Therapeutics
Two scientists smiling and talking while holding tablets in a laboratory
Two scientists talking while holding tablets

Achieve consistent performance to make confident decisions

Inconsistent recovery, unpredictable quantitation, and slow, labor‑intensive protein digest workflows create major bottlenecks, while non‑specific binding during separations further reduces certainty, ultimately delaying critical insights and producing variable, inconsistent results.​​

Waters removes these barriers and helps you:​

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Clarity for complex molecules

In many labs, fragmented methods, detector, and software silos create incomplete data trails and slow decisions. This makes it difficult to consistently capture CQAs and to transfer methods smoothly from development to QC.​

Waters helps you streamline by matching the detector to the question and connects everything through one enterprise-wide software solution:​

  • Bring mass‑enabled specificity into everyday QC methods for post-translational medications, sequence variants and product or process impurities with SQ Detector 2 and ACQUITY QDa II Mass Detector.​
  • Achieve robust bioseparations with 10x improvement in assay precision and reproducibility with built-in error prevention and guided workflows for method fidelity, confident identification, and impurity analysis with Alliance iS Bio HPLC System.
  • See hidden heterogeneity with more accurate higher order structure quantification and identity with SEC‑MALS fully integrated with Empower CDS, the industry-leading software for pharmaceutical filings.
Read the Application Note
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Empower Software handles our data and ensures data integrity, which is critical to MLCM… contributes to reducing risk, lowering costs, and improving regulatory compliance." ​
—  Customer, SelectScience​

Build a foundation of compliance-readiness

Biopharma QC teams must stay audit‑ready while delivering reliable CQAs—but complex workflows, disconnected systems, and slow turnaround times make consistency hard to maintain. ​

Waters helps you to overcome these challenges by:​

  • Keeping methods traceable and inspection‑ready in Empower CDS, using standardized acquisition, processing, and reporting to maintain comparable results at an enterprise level​.
  • Providing real‑time visibility and actionable analytics through waters_connect System Monitoring and waters_connect Data Intelligence Software, paired with utilization tracking to improve uptime and your response to deviations.
  • Supporting instruments and informatics with Waters Professional Services, your partner to accelerate regulated deployments and support ongoing compliance through upgrades​.
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Frequently Asked Questions

ICH Q6B is the primary guideline for biotechnological and biological products. it outlines the tests and acceptance criteria for:​

  • Structural characterization: Sequence, folding, and post-translational modifications (PTMs)​
  • Physicochemical properties via LC-MS and LC: Molecular weight and isoform patterns​
  • Biological activity: Potency assays specific to the molecule’s mechanism of action​
  • Purity/impurities via LC-MS or SEC-MALS: Detection of aggregates, host cell proteins (HCPs), and process-related impurities​

Stability testing is guided by ICH Q5C, which accounts for the extreme sensitivity of proteins to environmental factors like temperature, oxidation, and shear. The FDA requires stability data, which includes an LC system and an appropriate detector to support the requested storage period and potency. [FDA Site Document]​

Empower Software supports a comprehensive suite of detectors (which is growing as its support expands), including:

  • Optical: Photodiodie Array (PDA), Tunable UV (TUV), Fluorescence (FLR), and Charged Aerosol Detector (CAD)​
  • Mass detection: ACQUITY QDa II Mass Detector for simple mass confirmation and SQ Detector 2​
  • Advanced characterization: Multi-Angle Light-Scattering (MALS) and Refractive Index (RI) for absolute molecular weight and aggregation studies

Waters provides high-resolution insights into the "molecular fine print," including peptide mapping, sequence variants, and PTMs (glycosylation, oxidation, deamidation). Our workflows standardize these critical attributes across development, QC, and bioprocessing.​

To ensure you aren't "losing" sample, a bioinert column and LC system, like the MaxPeak Premier Columns with low-adsorption surfaces and bioinert LC systems like the Alliance iS Bio HPLC System or ACQUITY Premier UPLC System are recommended. These technologies eliminate metal-sensitive interactions, improving recovery and peak shape for even the stickiest analytes.​

The "lab-to-lab" gap is a challenge that can be minimized by standardizing the digital environment through Empower CDS. Aligning with ICH frameworks, we help you preserve analytical intent and maintain consistent results across global manufacturing sites.​

Consistency

Confident decisions with bioinert and biocompatible LC systems, featuring MaxPeak High Performance Surfaces (HPS) Technology

Clarity​

Simplified precision for complex molecules and CQAs, using advanced mass spectrometry and light-scattering techniques​

Compliance​

A foundation of compliance-readiness, providing end-to-end data traceability and audit‑ready data through Empower Software​

Ready to learn how Waters brings consistency, clarity, and compliance together? Let's get started.​

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