BioPharma Compass^®

• Automation– entire workflows can be automatically performed, from acquiring LC-MS data to generating a report it’s a single process
• CFR 21 part 11o -合规工具n board, right after acquisition the data mover transfers data to a protected server
• Multi Attribute Methods (MAM)- allow to bring the focus of analysis where you need it. Fast and in-depth MAM assays are supported on the protein as well as the on the peptide level, respectively
• QC analysis- high throughput analyses by ESI and MALDI provide synthesis quality information, e.g., for peptides or oligonucleotides, and provide QC reports automatically based on intact mass measurements
• Ion mobility– using timsTOF instrument datasets, PASEF^®data vastly increase the sequence coverage of biopharmaceuticals, the sensitivity in Host Cell Protein analysis (HCP) and provide CCS values as further molecular property of biomolecules

Workflow-based software solution
BioPharma Compass^®2021 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.

The software 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 2021 to reduce report turnaround times and throughput using high resolution ESI-QTOF mass spectrometry.

MAM-assays can be carried out at the intact, domain (subunits) or peptide level using MS-only or MS/MS for top-down/middle-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 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.

MAM protein screening workflow for intact protein analysis: glycoform and heterogeneity quantification
The ultra-high resolution data from Bruker’s high resolution QTOFs and timsTOFs are uniquely beneficial to the identification of low level protein isoforms, ADCs orglycoforms during mAb characterization.

With Bruker's patented SNAP II algorithm and True Isotopic Pattern (TIP™) data quality, monoisotopic masses - e.g., of mAb subunits - areautomatically assigned with low-ppm accuracy. Scoring as key element of the workflows provides automated quality assessment and simplifies batch comparisons. Butterfly plots allow visual dataset comparison.

Top-Down Protein Sequencing: Sequence Variant Localization
Bruker's market-leading MALDI-TOF/TOF and ESI-QTOF-ETD high resolution platforms make top-down and middle-down analysis straightforward.

Automatic sequence confirmation and sequence curation help with N/C-terminal status assessment (clipping variants), localization of sequence variants and other quality attributes.

Peptide Level Analysis for Sequence Confirmation, Attribute Identification and Multi Attribute Monitoring (MAM)

Peptide Mapping:BPC simplifies peptide mapping data handling for high quality sequence confirmation, PTM identification and targeted MAM assay design.

MAM Peptide Screening:Clear overviews and detailed EIC-based validation make multi-attribute methods simple, delivering reliable results quickly. Results can be used for comparability assessments and time course analysis to monitor critical quality attributes (CQAs) quickly.

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

Multi-Target Screeningworkflows for LC-ESI and LC-free MALDI-TOF workflows open a broad range of applications. Depending on application and throughput requirements, both ionization techniques can be used synergistically to provide fast and in-depth analysis reports. Reports can be exported in various formats to the file system. The analysis results are reported in a traffic light overview, covering different quality attributes to reduce operator time. Ion mobility data acquired on the timsTOF Pro allow to extend the molecular characterization by the highly accurate determination of collision cross sections (CCS).

一个方法将在1000年代不同的samples, the information about them is provided as a sample table. The generic format supports very broad applications:

• Oligonucleotide and peptide synthesis QC
• Clone screening – e.g., sequence or glycoprofile based
• Rapid drug substance ID testing in 15 min for Fill & Finish operations
• Released glycan profiling
• Incoming goods testing (polymers, detergents, etc.)