生物制药指南针^®

• 自动化- 可以自动执行整个工作流程，从获取LC-MS数据到生成报告，这是一个过程
• CFR 21第11部分- 合规工具正在登机，收购后，数据移动器将数据传输到受保护的服务器
• 多属性方法（MAM）- 允许将分析的重点带到您需要的地方。在蛋白质和肽水平上分别支持快速和深入的MAM测定
• QC分析- ESI和MALDI进行的高吞吐量分析提供了合成质量信息，例如肽或寡核苷酸，并根据完整的质量测量自动提供QC报告
• 离子移动性– using timsTOF instrument datasets, PASEF^®数据大大增加了生物药物的序列覆盖率，宿主细胞蛋白分析（HCP）中的灵敏度，并提供CCS值作为生物分子的进一步分子特性

Workflow-based software solution
生物制药指南针^®2021年是一个基于向导驱动的，基于工作流的软件平台，适用于质谱专家和常规用户。在非管制环境中开发的方法可以锁定以进行常规的生物制药分析部署。可自定义的工作区适应了手头的任务，包括用户界面，方法开发和数据审核，全部从Office PC的舒适度中。

The software enables the routine of biopharmaceutical analysis offering dedicated

LC和MS工作流程从自动测量结果到报告生成。这样的
workflows are increasingly important in biopharmaceutical development, e.g., to
验证蛋白质序列并量化产品和过程相关的异质性，例如修饰曲线。这些多属性方法
（MAM）在BPC 2021中实现，以减少报告周转时间和使用高分辨率ESI-QTOF质谱法。

可以使用仅MS-himly或MS/MS在完整的，域（亚基）或肽水平上进行MAM-says，以进行自上而下/中下部和自下而上分析。专用的相似性评分可以使自动结果评估和报告具有颜色编码结果，以加速数据审查。蝴蝶图启用了视觉数据集比较。

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.

完整蛋白质分析的MAM蛋白筛选工作流程：糖型和异质性定量
Bruker高分辨率QTOF和TIMSTOF的超高分辨率数据对鉴定低水平蛋白质同工型，ADC或ADC或MAB表征期间的糖型。

With Bruker's patented SNAP II algorithm and True Isotopic Pattern (TIP™) data quality, monoisotopic masses - e.g., of mAb subunits - are自动以低ppm精度分配。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
布鲁克（Bruker）的市场领先的Maldi-Tof/TOF和ESI-QTOF-ETD高分辨率平台使自上而下和中倒入分析直接。

自动序列确认和序列策展有助于N/C末端状态评估（剪辑变体），序列变体的定位和其他质量属性。

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.

妈妈肽筛查：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.

宿主细胞蛋白（HCP）分析：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).

一种方法将在1000秒的不同样本上使用，以作为示例表提供了有关它们的信息。通用格式支持非常广泛的应用：

• 寡核苷酸和肽合成QC
• Clone screening – e.g., sequence or glycoprofile based
• Rapid drug substance ID testing in 15 min for Fill & Finish operations
• Released glycan profiling
• 传入的商品测试（聚合物，洗涤剂等）