Last year, more than 50 percent of new drugs were classified as biologics, and that number will continue to increase as total pharmaceutical spending1 is expected to increase to over $200 billion by 2017. However, while the regulatory pathway for small molecule drug development has been in place for more than 25 years, large molecule biologic development can be more complex as it requires extensive characterization and comparability studies.Unfortunately, characterization and comparability studies can be a slow and arduous process even though the logic may be straightforward – the faster you can characterize your biologic, the faster you can take the next step. Realistically, to fully monitor a biologic as it moves through the development pipeline, or assess how a biosimilar stacks up to the innovator, fast and multifaceted data processing and comparison tools are needed to compare product characteristics.
Ideally, researchers must be able to achieve confident molecular weight determination of the biotherapeutic and confirm sequence information by peptide mapping. Moreover, detailed analysis of post-translational modifications (PTMs) as well as calculations of unmodified to modified peptides must be performed to assess differences across samples. Multiple batches and lots of samples needing to be analyzed to establish comparability–while also highlighting any specific differences—only adds to the complexity.
A fast, easy-to-use tool for assessing comparability is needed to maintain development momentum. This is no small order, but new BioPharmaView™ Software 2.0 can deliver – by processing intact mass, subunit analysis, peptide mapping, and SWATH™ acquisition data for biologics characterization quickly and intuitively. Analysis becomes that much more powerful as visualization panes enable users to see RAW and processed data side by side. Protein Drug to Antibody Ratios (DAR) and peptide PTM ratios are calculated automatically, allowing you to spend less time crunching numbers and more time understanding your data. Want to stay ahead of out-of-specification results? Use the fast batch processing feature of BioPharmaView Software to analyze a large numbers of samples, and the automated Pass/Fail flagging criteria to alert you automatically if any feature does not meet your established comparability criteria.
For sure, we are excited about this new software, and you will be too. You can learn more about BioPharmaView™ Software 2.0 at the ASMS Annual User’s Meeting in San Antonio, Texas, June 5 -9, 2016.