BioPharma Compass ®

• automation- from the LC - MS data collection to report generation, the whole process can be executed automatically within the same workflow
• Accordance with the requirements of the CFR 21 part 11- compliance tools can make data immediately after being collected uploaded to the protected server
• Multiple Attribute Methods (Multi Attribute the Methods, MAM)- focus on analysis of the core problems quickly, on the level of proteins and peptides can be rapid and thorough analysis of the MAM
• QC analysis- ESI and MALDI high-throughput analysis synthesis quality information, such as peptides and oligonucleotides, and based on molecular weight measurement result automatically generated complete QC report
• Ion mobility- use timsTOF mass spectrometer PASEF ® model data, greatly increase the coverage of sequence of biological medicine, analysis of the host cell protein (HCP) sensitivity, and provide the molecular biological molecules CCS value attributes

Based on the workflow software solutions

BioPharma Compass ® 2021 is a wizard-driven software platform based on the working process, suitable for mass spectrometry experts and general users.In the regulatory environment in the development of methods can become specificity, used for routine analysis of biological drugs characterization.Customizable software interface can be used to hand a variety of analysis tasks, including the user interface, method development and data review, all of which can be conducted on your office computer.

The software for the analysis of conventional biological pharmaceutical proprietary software.

LC and MS workflow from automatic report generation can be measured automatically.This workflow in the biological medicine development is more and more important, for example, verify the protein sequence, and quantify the heterogeneity of product and process related, such as modified analysis.The multi-attribute method (MAM) in the built-in BPC 2021, ESI - QTOF with high resolution mass spectrometer, can shorten the report period, improve the analysis of flux.

MAM - detection can be in complete, the structure domains (unit) or peptides, using MS/MS/MS for top - down/middle - down and bottom up analysis.Special similarity score algorithm can realize the automatic evaluation result, and report results in a different color, to speed up the data review, support visualization data sets are mirror image display function.

BioPharma Compass ® (BPC) can automatically perform a full report from the collection and analysis to the common biological pharmaceutical analysis workflow.To meet the requirements of the CFR 21 part 11 regulations laboratory can choose compliance toolkit, leading to obtain data security function.

MAM protein screening process, the full levels of proteins glycosylation and heterogeneity of quantitative analysis
Brooke's high-resolution QTOF and timsTOF in ultra high resolutionMAb characterizationTo low levels of protein in charge of different plasmids, ADC or glycoprotein analysis has unique advantages.

With the aid of brooke patented SNAP type II algorithm and real isotope peaks (TIP ™), can obtain the single isotope of macromolecular protein quality (mAb subunits, for example),Quality error is lower than the PPM level.Scoring system as the key elements of the work flow, providing automated data quality assessment, and simplify the comparative analysis between batches, mirror image allows visualization data set.

Top - Down of the protein sequence: the sequence variation
Brooke market-leading ESI and MALDI - TOF/TOF - QTOF - ETD high-resolution platform to make Middle and Top - Down - Down analysis become simple and clear.

Automatic sequence mutation analysis function can be used to identify and N/C terminal condition assessment (shear variant), sequence variants other quality attributes of monitoring and positioning.

In sequence confirmed, properties, identification of peptides levels and multiple attribute monitoring (MAM)

Peptide spectra:BPC simple peptide spectrogram analysis process can be high quality confirmation, modification after translation for identification of the sequence and targeted analysis of MAM.

Peptides MAM monitoring:Clear panorama and verification results in detail based on the EIC makes MAM method is simple, and fast delivery and reliable results.Results can be used in the comparison process analysis, evaluation and time in a quick monitoring key quality attribute (CQA).

The host cell protein (HCP) analysis:Make full use of brooke innovation timsTOF Pro ion mobility QTOF the advantage of mass spectrometer, the BPC further expanded the brooke professional in the field of biological pharmacy, using PASEF ® depth analysis of the host cell protein (HCP), and can use ten minutes of gradient of single enzyme enzyme mAbs samples high sequence analysis of the coverage.

Multiple objective screening

Based on LC - ESI and MALDI - TOF without LC multi-objective screening process greatly expands the application range.Based on the requirement of application and flux, can use these two kinds of ionization technology together, to provide rapid analysis report.Reports can be derived in various formats to the file system.The results of the analysis based on the number of traffic light display, and color represents different quality attributes, in order to reduce operator time.

Ion mobility of data obtained in timsTOF Pro allows through highly accurate collision cross section (CCS) extended molecular qualitative ability.

Single method can be used to deal with 1000 different samples, the samples, according to the information in the form of sample product supports a variety of scenarios:

• Quality control of oligonucleotides and synthetic peptides
• Based on clone selection - such as sequence or clone selection of glycosylation analysis
• To test the drug quickly within 15 minutes, and can be used to confirm before filling drugs
• Free indican analysis
• Raw materials testing (polymer, detergent, etc.)