Biopharmaceutical Analysis Software

BioPharma Compass®

A workflow-based software platform, suitable for mass spectrometry experts and routine users alike

Accelerate analysis

通过自动化简化常规工作流程

biopharma-compass

Punti salienti

BioPharmaceutical Analysis Software

BioPharma Compass®methods secure highest reproducibility

速度
Comprehensive workflows for automated biopharmaceuticals characterization from acquisition to report generation in a single process.
Simplicity
Well documented and preinstalled workflow methods provide for a steep operator learning curve and fast return of investment. Automated result interpretation supports shortening analysis turn-around times.
多功能性
适应用户需求和可扩展a single workstation to a client server network spanning a global biotech enterprise.
Compliance
The regulatory toolkit supports work under regulated conditions. The data mover enables data transfer to a protected server for utmost data security and access is limited through the database under audit trail.

Caratteristiche

BioPharma Compass

MAM analyses are enabled on the intact protein level as well as on the protein digest level

  • Automation– entire workflows can be automatically performed, from acquiring LC-MS data to generating a report it’s a single process
  • CFR 21 part 11– compliance tools are on 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- 使用timstof仪器数据集,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

基于工作流的软件解决方案
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.

该软件启用生物制药分析的常规提供专用的


LC and MS workflows from automated measurements to report generation. Such
工作流程在生物制药的发展中越来越重要,例如
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.

Benefici

BioPharma Compass

BioPharma Compass®提供生物制药研发和过程开发的答案

BPC可以自动化常见的生物制药分析工作流程,从获取和分析到完整报告。21 CFR第11部分的实验室合规性将受益于监管选项,包括领先的数据安全功能。


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

凭借Bruker的专利SNAP II算法和True同位素模式(TIP™)数据质量,单异位质量 - 例如,mAb亚基 - 是 -automatically assigned with low-ppm accuracy。作为工作流程的关键要素的评分提供了自动化的质量评估,并简化了批次比较。蝴蝶图可以进行视觉数据集比较。

自上而下的蛋白质测序:序列变体定位
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.

用于序列确认,属性识别和多属性监视(MAM)的肽水平分析(MAM)

肽映射:BPC简化​​了用于高质量序列确认,PTM识别和靶向MAM测定设计的肽映射数据处理。

MAM Peptide Screening:清晰的概述和基于EIC的详细验证使多属性方法变得简单,可以迅速提供可靠的结果。结果可用于可比性评估和时间课程分析,以快速监视关键质量属性(CQA)。

MAM Peptide Screening for PTM quantification based on Extracted Ion Chromatograms (EICs)


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.

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


脱糖基化西妥昔单抗FD亚基的中 - 中 - 序列分析完全证实了该序列。


PASEF®检测到的低PPM HCP。由CCS确认。

应用

BioPharma Compass

Suitable for a wide range of applications

多目标筛选LC-ESI和无LC的MALDI-TOF工作流程的工作流程开放了广泛的应用。根据应用和吞吐量的要求,两种电离技术都可以协同使用以提供快速和深入的分析报告。报告可以以各种格式导出到文件系统。分析结果在交通信号灯概述中报告,涵盖了不同的质量属性以减少操作员的时间。在timstof Pro上获得的离子迁移率数据允许通过高度准确的碰撞横截面(CCS)来扩展分子表征。

一种方法将在1000秒的不同样本中起作用,提供了有关它们的信息作为示例表。通用格式支持非常广泛的应用:

  • Oligonucleotide and peptide synthesis QC
  • 克隆筛选 - 例如序列或基于糖基的筛选
  • 填充和完成操作15分钟内快速药物ID测试
  • 发布了聚糖分析
  • Incoming goods testing (polymers, detergents, etc.)
合成寡核苷酸的QC分析one of several applications enabled by the Multi-Target Screening workflow.

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