8th Annual Biotherapeutics Analytical Summit

March 20 - 24, 2017
Bethesda, MA

Meet Genedata Expressionist experts at booth #13 at  in San Diego, CA, USA. the 8th Annual Biotherapeutics Analytical Summit, Bethesda, MA, UA.

Don't miss the opportunity to see how Genedata solutions efficiently support the whole biopharmaceutical R&D workflow, including screening and protein engineering, expression and purification, characterization and analysis of protein therapeutics, cell line design and development, bioprocess optimization, and quality control of biologicals.

To get more information about Genedata Expressionistsolutions, please contact expressionist@genedata.com.

Recommended Oral Presentations

Automated Data Processing for Quality Monitoring of Biotherapeutics by Multi-attribute Methods (MAMs)
Joe Shambaugh, Ph.D., Senior Scientific Consultant, Genedata

Advances in Characterization Methods & Approaches Session
Tuesday, March 21 | 3:20 - 3:50

Large molecular complexity of products coupled with the inherent difficulty in controlling complex bioprocesses present significant challenges for the manufacturing of biotherapeutics. Therefore biopharmaceutical industries adopt complex and costly process monitoring strategies and quality systems to ensure final product quality. The monitoring of critical quality attributes (CQAs) is currently performed using an array of analytical techniques. Although routinely used as release tests, these techniques generally do not measure attributes at the molecular level. In this context, many industrial players are exploring the adoption of innovative analytical approaches employing mass spectrometry (MS) to enable direct measurement of CQAs at the molecular level. In addition, MS-based methodologies offer the benefit of measuring many different quality attributes on a given biotherapeutic with a single test. These multi-attribute methods (MAMs) can potentially reduce development and manufacturing costs and at the same time increase product quality (safety and efficacy).

We present an implementation of MAMs using the Genedata Expressionist® software platform for the data processing, analysis, and management of MS data. In this approach, dedicated workflows are tailored to measure the CQAs for a given biomolecule, while testing for impurities (new peak detection), as well as checking the instrument qualification (system suitability). Raw mass spec data from enzymatically digested samples are loaded directly into the software and the workflow are executed with a one-click operation.  Optimized data processing are applied on large data sets and execution times scaled linearly with the number of samples. Browsing and downstream data analyses including statistical tests, visual verification of the results, and generation of customized reports are performed. This approach can be fully automated and employed as part of a bioprocess control strategy. In this case, we show as an example the real-time monitoring of quality attributes of the materials produced in a bioreactor. A compliance module including GxP functionalities such as audit trails, electronic signatures and data security, allows the deployment of this MAM implementation in regulated environments.

Recommended Poster Presentations

Deconvolution of Intact Mass Spectra for Drug-to-antibody Ratio Quantification of Antibody-drug Conjugates (ADCs)
David Bush, Ph.D.,  Senior Scientific Consultant, Genedata

Automated Data Processing for Quality Monitoring of Biotherapeutics by Multi-attribute Methods (MAMs)
Joe Shambaugh, Ph.D.,  Senior Scientific Consultant, Genedata

Automated Workflow for the Host Cell Protein Monitoring by Mass Spectrometry: From Raw Data to Final Report
Stefano Gotta, Ph.D.,  Senior Scientific Consultant, Genedata