The clock is ticking.

Your molecule’s safety and efficacy hangs in the balance. And you bear both the promise and the burden of
knowledge. Everything depends on your data—on knowing your molecule inside and out, upstream and down.

You have multiple product and process attributes to measure. Numerous ways to test them. A labyrinth of
regulatory pressures to navigate while maintaining data integrity and compliance. Collaborations that cross
borders with developmental phases that span platforms, contractors, vendors, and countries. In all that
complexity, the answers you need can get lost in translation.

You need definitive answers that cut through the complexity. Data that’s harmonized across methods,
instruments, and platforms, at any developmental phase anywhere in the world.

Biology can be variable. But your results shouldn’t be.

Sign up to receive updates on harmonization

Blog Series: Biopharma Data Harmonization


To get the most out of recent innovations in biopharmaceutical development and QC such as multi-attribute monitoring, it’s time to
better connect the systems that manage biopharma data. This series explores the what, the why, and the how of better biopharma data.

Biopharm Data: Chaos or Harmony?

Imagine a biopharma nightmare scenario: You are developing a large-molecule drug, a therapeutic monoclonal antibody (mAb). With strong phase three clinical trial results, your molecule looks promising…

Learn More

Biosimilars Intensify the Need for Harmonized Data

Biosimilars represent a race by many competitors to bring a complex, high quality product to market. And the companies that so far seem to be winning have made a key investment: process innovation…

Learn More

From the Results of Yesterday to the Drugs of Tomorrow

As analytical methods become more robust and data-intensive, and as competition to bring biologics to market increases, the need to handle more data, faster, becomes ever more acute. This poses a brute processing problem: What to do with all that data?…

Learn More
Bioharmonization Blog 4

Enhancing Analytical Productivity by Breaking Down Silos (Part 1)

As the biopharma industry continues to expand companies must have a clear organization-wide strategy for breaking down analytical silos and meeting compliance and data integrity requirements…

Learn More

Enhancing Analytical Productivity by Breaking Down Silos (Part 2)

With a focus on speeding development and manufacturing timelines for multiple drug candidates simultaneously, biopharma companies have increasingly turned to outsourcing partners that can do the work…

Learn More

Enhancing Analytical Productivity by Breaking Down Silos (Part 3)

Analytical data can be so much more than a historical point in time documented in a single report. In fact, biopharmaceutical organizations can use LC-MS data to build a continuum of compliance…

Learn More

What’s New

LCGC Article: The Role of Mass Spectrometry in Biopharmaceutical Drug Discovery and Development

View Article


Related Topics

Data Integrity

Data Integrity is an important part of biopharm data harmonization
and refers to the overall completeness, accuracy, and consistency of
data and processes during its entire life cycle.

Visit our Data integrity page for more info

Multi-attribute Monitoring

Multi-attribute monitoring methods (MAM) allow a single MS to
analyze multiple CQAs quickly, and permits scalability into the
workflow as more complex data is collected.

Visit our MAM blog series for more info


At Waters, we are preparing for a world with a single informatics framework that merges instruments and
software, discovery through approval, mass spec with chromatography. A way to turn chaos into harmony.

That’s why we’re continually developing workflow solutions that translate complexity into clarity, so you can
access all the knowledge you need to move your molecule forward from Point A to Point FDA and beyond.

Waters Biopharm Solutions


Waters platform solution integrating robust UPLC-MS characterization technology with comprehensive software, for applications in:

  • Bioseparations
  • Intact protein mass analysis
  • Peptide mapping
  • Released glycan analysis

Learn More


Waters’ solution to meet the demands of today’s fast-paced biopharmaceutical late development and quality control laboratories by enabling complementary optical and mass analysis techniques to be run on-line in a single screening workflow for improved productivity in data analysis.

Learn More

What’s New in Products


Biocompatible UHPLC system designed with unique Arc Multi-flow path™ technology to provide the versatility and robustness required to efficiently transfer, adjust, or improve your methods without compromising method integrity.

Learn More


New column technology designed to deliver high-efficiency separations, new levels of resolution, and increased throughput for facilitating improved characterization assays.

Learn More

Sign up to receive updates on harmonization