The Column - February 2009 - (Page 12)

Incognito The Column www.thecolumn.eu.com February 2009 Gregor Schuster/Getty Images Going Bio… With the increasing drive towards biopharmaceutical technology and the use of “larger molecules”, Incognito asks if there is still space for the “small molecule” chromatographer. I came across Figure 1 recently whilst trawling for information and it prompted to me to consider if my stock phrase; “I’m a small molecule person…” would be able to protect me from the alien (to me!) but high profile advance of biopharmaceutical technology for much longer. Is the future of pharmaceutical development and manufacturing really changing at such a pace and will my “small molecule” mentality towards pharmaceutical analysis last me until retirement, or do I need to seriously consider acquiring some new skills? Some background information then, for those of you who also need to start from the very beginning. “Biopharmaceutical” is a fairly broad term that encompasses proteins (typically monoclonal antibodies MAbs), viruses, vaccines, blood products or gene transfer products and in 2002 Walsh proposed the following definition — “a protein or nucleic acid based pharmaceutical substance used for therapeutic or in vivo diagnostic purposes, which is produced by means other than direct extraction from a native (nonengineered) biological source”.2 Confused? — read on for a short discussion on some fundamental differences between small molecule and biopharmaceutical thinking. During development, once a suitable target protein associated with a disease state has been identified and validated using cell and/or animal models, small molecule pharmaceutical development typically follows a path of synthesis and screening of compound libraries followed by fairly extensive “hit to lead” medicinal chemistry development programmes. However, even with convincing biological validation, a chemistry effort on a novel target will not guarantee production of suitable leads for clinical development. Author: Incognito E-mail: incognito@thecolumn.eu.com Biopharmaeutical development differs and can follow different approaches. If activity of the target protein alleviates the disease, then the target itself could be developed into a drug (e.g., erythropoietin, insulin, Factor VIII). Alternatively, if target activity accentuates the disease phenotype, then a neutralizing antibody or soluble receptor approach is the logical development strategy and many successful biopharmaceuticals target disease-related proteins such as tumour necrosis factor (TNF). Therapeutic proteins can be developed even when the biology of a target is not well understood. Development of monoclonal antibody (MAb) drugs is one example where correlative biological data (using proteomics for example) can identify tumour-specific markers and can be valuable in demonstrating that target activity mediates a disease. When advancing into preclinical and clinical development, biopharmaceuticals have additional advantages over smallmolecule drugs. For example, protein drugs are often more selective and safer to use than small molecules and can be developed with smaller, shorter and cheaper clinical trials.3 However in the period 2006–2007 biotech companies had 47 FDA approvals (45% of the total approvals), but had 68 Phase III failures that represented 74% of the total Phase III failures,4 which might suggest a higher attrition rate at this late (and presumably costly) development phase. For 2007 the estimated total capitalized cost per approved new molecule was nearly the same for biopharmaceuticals as for small molecules when all factors are considered ($1241 million versus $1318 million).5 However, there are other important drivers for pursuing growth in biopharmaceuticals including reduced exposure to generic competition, access 12 http://www.thecolumn.eu.com

Table of Contents for the Digital Edition of The Column - February 2009

The Column - February 2009
Contents
Rapid Sample Preparation Technique for the Extraction of Dioxins and Furans from Animal Tissue and Animal Feed Using Pressurized Fluid Extraction
News
Incognito
Market Trends and Analysis
Tips and Tricks: GPC/SEC
Multi-residue Pesticide Analysis in Foods Using Modified QuEChERS Extraction and Ion Trap GC–MSn Analysis
Quantification of Protein Phosphorylation Using Chip-based LC–MS
A New Perspective on the Challenges of Mass Spectrometry
Q&A

The Column - February 2009

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