Review of critical factors, analytical methods and experimental approaches
Therapeutic proteins have revolutionized the treatment of many diseases and have a promising future with more than forty monoclonal antibodies and Fc-fusion therapeutics already on the US market and over 400 more in clinical development stages. Therapeutic proteins are, however, hit hard by a high attrition rate, mainly to poor efficacy, which results in only one in ten making it to market. Increasing the success rate relies on many factors, including the study of absorption, distribution, metabolism and excretion (ADME), as Jay Tibbitts at UCB Celltech, UK, and his coauthors point out in their extensive review on the subject.
