The techniques outlined herein are used throughout the product lifeline, in preclinical phases to gain an understanding of
the product, to demonstrate that changes to the manufacturing processes, for example scaling up of the process, do not alter
the structure and physicochemical properties of the product and to provide data to demonstrate consistency of manufacture
of the product. Also, increasingly, characterization-based techniques, such as peptide mapping and oligosaccharide profiling,
are being used as part of the release testing regime to release products into clinics for trials and eventually onto the market.
In the development of any mAb product at least three and usually several batches will be characterized to the full extent
In summary, a battery of analytical techniques are required to fully characterize mAb products. In addition, for submissions
to the regulatory authorities, analysis to GLP and cGMP are required. Full characterization of a mAb according to the EMA
and ICH guidelines can now be carried out in a matter of weeks, and continuing improvements in instrumentation are constantly
allowing analytical laboratories to obtain data with more sensitivity, accuracy, and resolution. The challenge is to remain
at the forefront of these technologies and to incorporate the increasing list of other appropriate techniques such as fourier
transfrom–infrared (FT–IR) analysis to complement secondary structure analysis using CD and field flow fractionation to provide
an additional assessment of aggregation where appropriate, in the characterization of mAbs and other biopharmaceuticals.
ANDREW J. REASON, PHD, IS managing director of life science services at SGS M-Scan, Berkshire, United Kingdom. Andrew.Reason@sgs.com
1. IMS Midas and Knowledgelink; http://Pipelinereview.com/, Top 30 biologics 2010, special edition, Jan. 2011,
http://www.pipelinereview.com/free-downloads/TOP_30_Biologics_2010_RDPN_Special_Mar_2011.pdf, accessed April 2011.
2. EMA, Guideline on Development, Production, Characterization and Specifications for Monoclonal Antibodies and Related Products (London, Dec. 2008).
3. ICH, Q6B Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (1999).