JENS HOEFKENS¹, ALESSIO CERONI², PETER HABERL², ANTHONY TAYLOR³
1. Genedata Inc., 750 Marrett Road, Lexington, MA 02421, USA
2. Genedata GmbH, Lena-Christ-Strasse 50, 82152, Martinsried, Germany
3. Genedata AG, Margarethenstrasse 38, 4053, Basel, Switzerland

Abstract

The biotherapeutics market has enjoyed exceptional growth in recent years. Comprehensive characterisations of biopharmaceuticals have become increasingly important, especially for regulatory submissions. With improvements in performance, sample throughput and sensitivity, mass spectrometry (MS) is replacing traditional methods in an increasing number of applications such as identification of post-translational modifications (PTM) and glycosylation studies. However, the sheer volume of data produced by modern MS instruments has led to a bottleneck in data processing. This article gives an overview of MS-based techniques currently used for the characterisation and analysis of biotherapeutics. It will specifically detail recent developments in bioinformatics that offer innovative approaches for greatly streamlining these processes. As an example, the article will discuss an alternative process for batch control.

INTRODUCTION
Over the last decade, biotherapeutics have become an increasingly exciting topic. In 2006, recombinant biologics generated global sales of US $ 63.8 billion. Recently published figures (1) show that sales have virtually doubled to US $ 124.6 billion in 2012. So, why has biotherapeutics become such a hot topic?

The pharmaceutical industry has known for a number of years that it is facing huge revenue losses due to the patent cliff (2) -- the expiration of patents on small molecule drugs. In 2013, drugs with annual revenues of $ 29 billion came off-patent and it is estimated (2) that over 70% of these revenues will be lost to generics. By 2016, a total of $ 84 billion in global revenues is at risk due to drugs coming off-patent. Industry insiders believe that only innovative biotherapeutics will be able to make a significant contribution to the restocking of drug pipelines and so the strong focus on biotherapeutics as biopharmaceuticals have:

• alternative modes of action to make new drug targets available, which are intractable for small molecules; 
• inherent specificity for a target;
• favourable att ...
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