WILL YOUR BIOPHARMA DATA LIVE IN CHAOS OR HARMONY?
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.
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. Simply getting this far means your molecule has already beaten the odds, succeeding past a point where hundreds of others have failed. To cross the finish line, you’re preparing for commercial production. Tens or hundreds of millions of dollars are on the line. Then an artifact shows up in your QC data…
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. And behind those advances in streamlining and controlling the process are improvements in gathering and managing data.
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? While large drugmakers have begun to integrate data through platforms developed in-house, that option is usually only available for the biggest multinationals. Yet along with the sheer fact of so much data, the need to maintain data integrity to satisfy regulators adds an additional layer of complexity.
LCGC Article: The Role of Mass Spectrometry in Biopharmaceutical Drug Discovery and Development
Recent Articles of Interest
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 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:
- Intact protein mass analysis
- Peptide mapping
- Released glycan analysis
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.
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.