From the Results of Yesterday to the Biologic Drugs of Tomorrow

Avoiding data disasters

To get the most out of recent innovations in biopharma 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.

Data disasters — a computer virus erases development records, an out-of-range QC result delays commercialization — are eye-catching and vertigo-inducing for professionals in biopharma to imagine. But it’s the smaller, more mundane delays caused by data disconnects where the real drain occurs, and the real opportunity exists, in workflow improvement.

Instead of the dramatic crash, think of the weekly report delayed for a day or two as data has to be reprocessed to become meaningful to decision makers.

Or the risky (and unfortunately still common) practice of scientists exporting data onto a flash drive in order to move it to a new platform, made necessary by instrument and software incompatibility.

Both cases exemplify the thousand small delays and opportunities for error that can snowball over the years of a complex drug development program. They add up to lost time and increased risk in an endeavor that has little tolerance for either.

It doesn’t have to be this way.

What harmonized data can do

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 drug makers 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.

At Waters, we envision the emergence of a more connected data acquisition and management platform accessible to all involved in biopharma. One crucial element we’ve learned from our more than 20 years in deploying Empower Chromatography Data software (CDS) in the industry is the need for such a platform to be vendor-neutral and instrument-agnostic in acquiring data.

Such a simple-sounding feature has wide implications, since the analytical instruments used in different discovery and development phases are usually different. The high sensitivity and specialization in early phases tend to give way in later phases to instrumentation that emphasizes robust, repeatable performance, maximum up-time, and regulatory compliance.

Combine this with the fact that development phases occur at different sites, sometimes through external third-party organizations, sometimes in another country, and many complexities and risks emerge. A full vendor-neutral platform has the potential to seamlessly integrate data from diverse instrument platforms both within phases and between them, and to result in a data package that’s continuous and easily transferable.

Another key element in an improved data platform is compliance. This arises in the need for data that’s ready to report to regulators from the moment it’s acquired. This focus on data integrity represents another competency we have tested through hundreds of Biologics License Applications processed using our Empower CDS.

Along with compliance-ready data, a more connected data platform also can bring drug makers closer to the intention behind initiatives such as the FDA’s push for Quality by Design (QbD), which seeks to fully imbue safety and efficacy in drug products starting in early process development. Establishing understanding and control of the process from its earliest iteration, and extending that control all the way to the market and beyond, is key to defining and using the design space QbD envisions.

Moving into the future

In the near future, the disparate data platforms serving biopharma have the potential to become integrated. This connected platform promises to serve as the foundation for other emerging innovations, such as automation or continuous processing. It also assures the realization of the potential of mass spectrometry-based, multi-attribute monitoring methods to combine assays into more accurate, efficient analyses. This will create a stronger bridge between developmental phases, between process parameters and critical quality attributes, and between the results of yesterday and the drugs of tomorrow.

Visit waters.com/tamethechaos for more information.

Related:

• Part Two: Biosimilars Intensify the Need for Harmonized Data
• Part One: Biopharma Data: Chaos or Harmony?
• From Characterization to Late Development, Manufacturing, and QC: The Expanding Role of Mass Spectrometry in Biotherapeutics