Accelerate biopharmaceutical late-stage development, commercialization, manufacturing, and quality control (QC) by easily and reliably obtaining compliance-ready, high-quality mass information.
The Thermo Scientific Orbitrap Exploris MX mass detector is the perfect fit for deploying routine mass monitoring.
In addition to high-resolution mass detection provided by Thermo Scientific Orbitrap mass analyzers, this fit for purpose system is simple to operate and compliance ready with Thermo Scientific Chromeleon chromatography data system (CDS) software. Consistent performance between the Thermo Scientific Orbitrap Exploris 240 mass spectrometer and Orbitrap Exploris MX detector ensures seamless method transfer from development to QC.
Presented by Andrew W. Dawdy, Ph.D., Principal Scientist,
BioTherapeutics Pharmaceutical Sciences
Simplify tasks and reduce errors for more ‘right first time’ analyses with Chromeleon CDS, with built in methods, control, data processing, and management. The suite of smart tools makes your work faster and easier, while ensuring reproducible, high-quality mass monitoring.
High uptime boosts productivity. Rapid “set and forget” calibration procedures provide consistent mass stability for at least four weeks at prescribed conditions. Instrument status monitoring and optimized pressure control alert users when maintenance is needed, avoiding unnecessary downtime and repeat analyses.
Designed for data integrity, data security, and compliance, fully scalable Chromeleon CDS provides comprehensive technical controls to give you a competitive edge in meeting global regulatory requirements.
Robust and reliable performance from system to system and site to site ensure confidence in results used to make critical decisions. Industry-proven Orbitrap technology, now purposely designed for mass monitoring in future-proof lab operations.
Easy transfer of sophisticated Multi-Attribute Method (MAM) assays from development to manufacturing bridges the gap between development and QC.
The dedicated, global Thermo Scientific MAM team maximizes your productivity and confidence with installation, training, and fast service and support. Standardized system performance evaluation test (SET) and installation qualification/operational qualification (IQ/OA) thoroughly assess system performance with comprehensive installation and post-maintenance acceptance criteria.
Benefit from the end-to-end Thermo Scientific MAM 2.0 workflow approach to comprehensive characterization and monitoring of biotherapeutics from development to commercialization. Orbitrap Exploris 240 mass spectrometer methods, established during development, seamlessly transfer to the Orbitrap Exploris MX detector in manufacturing or by contract partners. In addition to full integration into the high-resolution MAM 2.0 workflow, the usability and low cost of the Orbitrap Exploris MX detector make it the perfect fit for high-throughput QC and contract labs.
Users can identify and evaluate relevant product quality attributes (PQAs) via high-throughput analytics provided by Thermo Scientific BioPharma Finder software. Connected labs can access data from development through QC using MAM 2.0 powered by Thermo Scientific Ardia Platform. And, PQAs can be monitored throughout the entire drug development process using the MAM target peptide workbook built from the list of identified peptides upon incorporation into a Chromeleon processing method. The processing method along with the instrument method, injection sequence, view setting and report template can be stored into a MAM eWorkflow for easy and direct transfer to QC via Chromeleon CDS Enterprise software.
Post-translational modifications (PTMs) and process-induced modifications can occur during upstream and downstream bioprocessing, formulation, and storage. Any PTMs impacting safety or efficacy are critical quality attributes (CQAs) that must be monitored and controlled. Liquid chromatography mass spectrometry (LC-MS) MAM offers simultaneous, direct, site-specific identification and quantitation of a broad set of peptide CQAs. With the ability to replace multiple assays used during drug development and manufacturing, MAM can accelerate approvals, increase product and process knowledge, reduce development time, and reduce lot release assay cost and time.
The Orbitrap Exploris MX detector adds unprecedented simplicity, robustness, and HRAM-enabled confidence to MAM workflows. In addition to operational productivity, integrated Chromeleon CDS provides superior MS data-processing tools and comprehensive controls for regulated labs.
Embraced by industry and regulatory leaders, MAM is key to the future of high-quality biotherapeutics. MAM adoption across all stages of development and manufacturing enables efficient and comprehensive understanding of processes and products by replacing many assays with one. Thermo Fisher Scientific has developed a fit-for-purpose MAM solution—now drug developers have the partner they need to aid them in deploying MAM.
The enhanced Orbitrap Exploris MX-based MAM workflow is applicable for monitoring PTMs such as glycosylation, deamidation, oxidation, peptides for sequence confirmation, and glycan profiling.
With optional mass range up to m/z 8000 and HRAM data quality, the Orbitrap Exploris MX detector is the ideal choice for rapid, high-confidence molecular weight profiling, even for complex mAb glycoforms at low concentrations. Confirming the molecular weight of large intact proteins under native and denaturing conditions is essential to biotherapeutic production and QC.
Analysis under non-denaturing conditions allows characterization of proteins in their near-native biological states. Previously, obtaining this information required multi-step labor intensive isolation and purification. Using native MS, quality attributes can be directly assessed with minimal need for sample preparation, rapidly providing mass information for all proteins in a sample.
The automated parameter optimizer makes it easy to obtain trusted results. Complementary deconvolution algorithms optimized for isotopically resolved and unresolved data provide accurate molecular weights for intact proteins, in both denaturing and native conditions, and at low abundances.
The Orbitrap Exploris MX detector is an ideal solution for sensitive and robust intact mass monitoring of oligonucleotide sequences and their low-level production related impurities. Compared to low-resolution instruments which only provide average molecular weight, HRAM data enables resolution of very closely related intact oligonucleotide sequences. Unlike software that relies on traditional peak picking algorithms, Xtract and ReSpect deconvolution algorithms implemented in BioPharma Finder software make use of the Sliding Window feature intact and provide mass deconvolution on a chromatographic time scale to identify failed oligonucleotide sequences and process related impurities, even at low levels or in poorly resolved chromatographic peaks.
HRAM LC-MS is the technique of choice due to its mass accuracy, reproducibility, robustness, sensitivity, and speed. HRAM capability is indispensable in verifying that an oligonucleotide has the expected molecular weight.
BioPharma Finder software provides an intuitive set of tools to support sequence modifications at each subunit of the oligonucleotide, including the nucleoside base, backbone linker, and 2’ ribose positions. Custom building blocks can easily be inserted into existing sequences or utilized for future sequence creation. Chemical modifications can also be created and searched to identify unexpected or variable modifications of the target sequence.
Simplify your workflow and get superior insights into your data. Benefit from ease of use, comprehensive instrument control, automated data analysis, and flexible reporting.
Complete biotherapeutic characterization includes intact mass analysis, peptide mapping, oligonucleotide analysis, top- and bottom-down analysis or multi-attribute method (MAM) workflows.