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.
Chrissy
Leslie, senior chemist in the Biopharmaceuticals Group,
performs electrophoresis to determine a protein’s identity
for clinical trials.
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.
