presented by Dr. Anke Schnabel, Team Leader Biotherapeutical Analytics, on the occasion of the 15th MASS SPEC 2018, September 9th-12th San Francisco, USA. (Publications)
A full method qualification for an IgG1 market product by mass spectrometry (MS)-based multi-attribute method (MAM) approach for New Biological Entities and Biosimilar Candidates Presented by a Full Method Qualification for an IgG1 Market Product
https://cdn.ymaws.com/www.casss.org/resource/resmgr/mass_spec/2018_mass_spec_final_program.pdf Page 52
The development of a biotherapeutics requires the establishment of product quality attributes (PQA) early in the development cycle to acquire a thorough understanding of the molecule characteristics. To develop the PQA, extensive analytical testing is required. Until recently, many individual analyzes were necessary. Now, the Mass spectrometry based MAM method (Multi-attribute method) approach has been proven to be a powerful tool during development and production of new biological entities and biosimilar candidates, and has the potential to replace conventional protein analytical methods for characterization and quantification of PQAs.
We present the application of MAM in IgG biosimilar development using Thermo Scientific Q Exactive instrumentation and the software solution (Protein Metrics Inc.) for fast processing of post translational modification (PTM) levels, N-glycosylation profile and amino acid exchange assessment. Based on a case study the principle of a molecule-specific method qualification of a MAM peptide mapping MS approach were introduced including the evaluation of the quality parameters: analyte autosampler stability, repeatability, intermediated precision, linearity and specificity of the method using appropriate stress samples.
The MAM approach offers the technical potential for validation and usage as GMP release testing for biopharmaceuticals. LC-ESI-MS is a s powerful tool in biotherapeutic development for assessment of critical quality attributes. Furthermore this integrated method gathers more data of the molecule characteristics, the produced data set get a more deeper insight with broader data bases as the matrix of analytical methods until now.
Through this approach we are able to help customers to streamline, speed up and save money in the development process.