This blog post covers a very interesting development in the biopharmaceutical industry, in which recent market trends indicate dramatic growth in large molecule development plus offers a downloadable application notebook featuring many applications for our next-generation biopharmaceutical analytical solutions.
From news reports, it is clear that many companies are investing billions of dollars towards new facilities to expand their capabilities and pipelines. Here are two recent GEN articles on this subject:
- The first article, Studies Suggest that When It Comes to Drug Development Success, Size Matters, discusses the shift towards large molecule development in pharma and away from traditional small molecule drugs.
- The second article, Massachusetts Sees $2B Construction Boom from the Biopharma Industry, talks about recent investments biopharma companies have made in new facilities to keep with up with growth.
In this booming biologics drug market, protein therapeutics, specifically monoclonal antibodies (MAb) make up the fastest growing segments. During development and production of these products, it is essential to thoroughly detect, characterize and quantify impurities, structural variants and modifications as well as monitor stability in order to demonstrate safety and efficacy. Some common analytical tasks include:
- Aggregation analysis
- Fragmentation analysis
- Charge variant analysis
- Post translational modification analysis which includes deamidation, oxidation, phosphorylation, N-acylation, amino acid substitutions and truncation, purity checks, peptide mapping, and glycan and clycosylation changes
The Protein Therapeutics Application Notebook (link to short form that takes 20 seconds to fill out) provides an in-depth look at many of our workflow solutions, a list of highly recommended peer-reviewed publications, and application notes that optimize the analysis and development of biologics. Applications for characterizing biologics include the following topics:
- Charge and heterogeneity analysis with various types of chromatography
- High throughput and automation
- Peptide mapping
Let us know of your protein therapeutics and MAb challenges in the Comments box below. Our experts will be pleased to answer your questions!