Analytical testing to support biopharmaceutical products
Due to their complexity, biopharmaceuticals require a vast array of testing matrices. Dr. Jon S. Kauffman, director of Method Development and Validation and Biopharmaceutical Services, has published an article in The BioPharm International Guide. The article, “Analytical Testing to Support Biopharmaceutical Products,” is featured in the April 2007 issue.
The article discusses the significant amount of analytical testing required to support a biopharmaceutical product - from discovery, through development, clinical trials and manufacturing and eventually to the market. Due to the complexity of these large molecules, arrays of methods are utilized to fully characterize these complex molecules - a significantly more difficult task than typical small molecules. Since biopharmaceuticals are produced by living systems, i.e. E. coli, yeast or mammalian cells, there are additional testing matrices associated with viruses and cell lines. Further, the FDA is requiring orthogonal techniques when available to better understand the structure and stability of a biopharmaceutical.
Currently, more than half of the drug candidates in the discovery stage are biologics including proteins, peptides, monoclonal antibodies, etc. As the overall number of these large molecules in the pipeline increases, many drug manufacturers may need to consider outsourcing portions of their analytical testing to Lancaster Laboratories to fill voids in capacity and/or meet timelines and remain competitive.