At the 2012 CASSS 9th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry, Bruker today launches the first software solution to encompass the complete biopharmaceutical characterization challenge, including glycoforms, impurities and modifications. The unique BioPharmaCompass 1.1 software allows biotech customers to leverage Bruker's leadership in cutting-edge mass spectrometry for intact protein and post-translational modification analysis in a routine industrial biologics environment.
BioPharmaCompass 1.1 introduces several major enabling innovations in the quest for a complete picture of biological products for regulatory approval and compliance:
Intact precise-mass product confirmation and impurity identification in a single run
Handling of multiple-point time-course studies including impurity analysis and stress studies
Antibody determination by top-down sequencing, including antibody-drug conjugate analysis with instant visualization of N and C terminal modification analysis against expected batch standard
Glycan profiling, PTM and artifact determination, localization and quantification including novel ETD (electron transfer dissociation) strategy for determination of deamidation sites
Rapid identity testing by peptide mass fingerprinting using digest match chromatogram search, as well as full software enablement of combined CID and ETD strategies for 100% sequence coverage even including formerly difficult-to-sequence domains
Automatic combination of data from multiple enzymatic approaches
The industry's first automated glycan profiling and identification workflow, expandable using Bruker's recently launched Glycoquesttm complete glycoprotein analysis solution and integrated library, making sophisticated glycoprotein identification and assignment as simple as a standard protein database search, combining protein sequence and glyco-structure sequencing data into a single 360 degree report
Bruker has pioneered the field of novel mass spectrometry techniques for the direct measurement and sequencing of intact proteins. The industry-leading highest resolution maXis ESI-QqTOF spectra available at maximum sensitivity for trace impurities, patented top-down ISD-T3 sequencing on Flex series MALDI TOF/TOF and best-in-class amazon ETD ion-trap technology for PTM analysis are all critical steps in a complete understanding of the composition of a biotherapeutic. Now, BioPharmaCompass 1.1 enables biotech and pharmaceutical customers to manage information from any or all of these unique capabilities, dramatically speeding the licensing and production of biological drugs.
Explaining the urgent need for the new solution, Dr. Ian Sanders, President of the Bruker Daltonics Life Science Mass Spectrometry division, commented: "The speed and completeness of the analytical picture is vital to our customers securing regulatory approval in this rapidly growing market. There is continual pressure to stay one step ahead of regulatory requirements and we aim to deliver the insight from the most sophisticated new MS approaches with the minimum of expert intervention required by the customer."
Bruker's launch follows successful trials by some of the leading organizations in biotherapeutics. Dr. Alain Beck, Senior Director, Antibody Physico-Chemistry, Center of Immunology at Pierre Fabre commented: "We had a chance to work with Bruker's scientists on antibody characterization by Mass Spectrometry including the use of BioPharmaCompass. We were really impressed by the performance of different complementary mass spectrometers as well as the ability of the software to identify minor modifications in the sequence."
The new development also delivers significant value in increased productivity in the industrial environment. Dr. Malcolm Saxton, Senior Scientist at Novozymes Biopharma, explained: "BioPharmaCompass has allowed our laboratory to significantly increase throughput. More samples are now analysed while scientists are able to spend a higher proportion of their time on complex problems and new method development. The automated data analysis carried out through BioPharmaCompass ensures high quality and, importantly, fully reproducible data is obtained, reported and traceably stored ensuring that trained staff only spend their time interrogating the samples that need further inspection."