BioPharma Compass 3.0

BioPharma Compass 3.1 – Accelerate Biopharmaceutical Analysis

BioPharma Compass 3.1 (BPC 3.1) is a wizard-driven, workflow-based software platform, suitable for mass spectrometry experts and routine users alike. Methods developed in a non-regulated environment can be locked down for routine biopharmaceutical analysis deployment. The customizable workspace adapts to the task at hand, including user interface, method development, and data review; all from the comfort of your office PC.

BPC 3.1 enables the routine of biopharmaceutical analysis offering dedicated LC and MS workflows from automated measurements to report generation. Such workflows are increasingly important in biopharmaceutical development, e.g., to verify protein sequences and to quantify product and process related heterogeneities such as modification profiles. These Multi-Attribute Methods (MAM) are implemented in BPC 3.1 to reduce report turnaround times and throughput using high resolution ESI-QTOF or MALDI-TOF mass spectrometry.

These MAM-assays can be carried out at the intact, domain (subunits) or peptide level using MS-only or MS/MS for top-down and bottom-up analysis. Dedicated similarity scoring enables automatic result assessment and reporting with color-coded results to accelerate data review. Butterfly plots enable visual dataset comparisons.

BPC 3.1 automates common biopharmaceutical analysis workflows from acquisition and analysis to full reports. Laboratories under 21 CFR Part 11 compliance will benefit from the regulatory options, including leading data security features.

Intact Protein Analysis: Glycoforms and Heterogeneity Screening

The ultra-high resolution data from Bruker’s maXis II UHR QTOF are uniquely beneficial to the identification of low level protein isoforms, conjugates or glycoforms during mAb characterization. With Bruker's patented SNAP II algorithm and True Isotopic Pattern (TIP™) data quality, monoisotopic masses - e.g., of mAb subunits - are automatically assigned with sub-ppm accuracy. Scoring as element of the workflows provides automated quality assessment simplifying batch comparisons. Butterfly plots allow visual dataset comparison.

Butterfly plot
Butterfly plot showing a deconvoluted spectrum from a test sample and a reference.

Top-down Protein Sequencing: Sequence Variant Localization

Bruker's market-leading MALDI-TOF/TOF and QTOF-ESI/ETD high resolution platforms provide rapid middle-down and middle-up protein biopharmaceutical analysis. The resulting data provide automatic sequence confirmation and support sequence curation, N/C-terminal status assessment (clipping variants) and localization of sequence variants, mis-incorporations and other quality attributes.

Middle-Down Sequence analysis of deglycosylated Cetuximab Fd subunit fully confirmed the sequence.
Middle-Down Sequence analysis of deglycosylated Cetuximab Fd subunit fully confirmed the sequence.

Peptide Level Analysis for Sequence Confirmation and Attribute Identification/Monitoring

BPC 3.1 simplifies viewing and reporting peptide mapping results for clear biopharmaceutical analysis and characterization and simple targeted MAM assay design. Clear overview and detailed validation screens are available for high quality sequence confirmation and modifications identification. Results can be used for comparability assessments, quality attribute monitoring and quantification (using MS or optical chromatograms).

Taking full advantage of the benefits of Bruker’s novel timsTOF Pro ion-mobility QTOF spectrometer, BPC 3.1 further extends Bruker’s expertise in biopharmaceutical characterization to deep dive host cell proteins (HCP) analysis with PASEF and provides high sequence coverage, single enzyme proteolytic digests from mAbs using sub 10-minute gradients.

HCP analysis result of NISTmAb reference material from a timsTOF Pro run with sequence coverage map of a selected protein in BPC 3.1.
HCP analysis result of NISTmAb reference material from a timsTOF Pro run with sequence coverage map of a selected protein in BPC 3.1.

Multi-Target Screening for LC-ESI and MALDI-TOF workflows open a broad range of applications

A single method will work on dozens to 1000s of samples, which are provided with respective molecular weight information as a sample table. The generic format supports very broad applications:

  • Oligonucleotide and peptide synthesis QC
  • Clone screening – sequence or glycoprofile based
  • Rapid ID testing in 15 min (Fill & Finish operation)
  • Incoming goods testing (polymers, detergents, etc.)
Serial QC analyses of oligonucleotide synthesis is one of several applications enabled by the Multi-Target Screening workflow.
Serial QC analyses of oligonucleotide synthesis is one of several applications enabled by the Multi-Target Screening workflow.

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For Research Use Only. Not for Use in Clinical Diagnostic Procedures.