Verify Buffers Before Use to Ensure Consistency and Quality

Bioprocessing is a highly complex, data-driven workflow and every step plays a critical role in delivering safe, effective biologics. As product pipelines grow and regulatory expectations rise, there’s increasing pressure on process teams to minimize variability, accelerate timelines, and ensure consistency across sites and batches. One of the most overlooked sources of process variability? Buffers.

Buffers are essential throughout downstream processing, supporting protein purification, stability, and final formulation. Yet they’re often assumed to be correct without consistent verification—introducing hidden impacts that can compromise yield, delay release, or impact product safety.

Why Buffer Verification Matters

Every downstream process step—from chromatography to UF/DF, sterile filtration, and final fill—relies on buffers with precise excipient concentrations. Variability at any point can lead to:

  • Purification failures
  • Protein aggregation or instability
  • Yield losses and batch rework
  • Delayed regulatory approval

In a typical production flow, buffers are often assumed to be correct. But assumptions don’t catch variability introduced by human error, raw material inconsistencies, or preparation deviations. And most traditional QC tools aren’t fast or precise enough to keep up with the pace of modern biologics manufacturing.

Bringing Visibility to Buffer Quality

The Atlas™ system, powered by proprietary High-Precision Tunable Laser Spectroscopy (HPTLS), delivers rapid, at-line buffer verification in under a minute—no sample prep required. With just a simple scan, Atlas provides accurate quantification of critical buffer components, including multi-component mixtures. The system’s specificity enables confident decision-making during:

  • Buffer stock creation
  • In-process buffer exchange
  • Final formulation, sterile filtration and fill/finish

Real-World Impact: Smarter QA, Fewer Surprises

Bioprocess scientists and quality teams are using Atlas™ to:

  • Validate incoming and in-house buffers
  • Screen batches before sending samples for more expensive assays
  • Monitor buffer consistency across CDMO transfers
  • Catch buffer degradation or pH shifts that impact final product quality

Don’t Let Buffer Variability Be Your Blind Spot

Buffers deserve more attention in downstream workflows—not more complexity. With systems like Atlas™ teams can move from reactive troubleshooting to proactive quality assurance. The result? Faster batch release, fewer deviations, and more robust biologic production from start to finish.

Interested in learning more? View our 25-minute webinar to explore buffer applications with data that demonstrates how buffer verification impacts key downstream steps.