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European Biopharmaceutical Review

Biopharmaceuticals: A Special Breed of Drugs

Biopharmaceuticals are protein or glycoprotein based drugs. They are high molecular weight molecules. Their therapeutic performance strongly depends on their secondary and tertiary structure that is stabilised mainly by non-covalent, rather weak forces. Changes in structure may lead to loss of therapeutic effect and safety concerns, such as the introduction of immune reactions against the biopharmaceutical.

With their delicate and fragile structure, biopharmaceuticals have to be treated differently than most small organic molecules (SOM) used as drugs. This special treatment not only applies to the different stages of the drug development process, but also to their production and handling by pharmaceutical and medical professionals and, last but not least, the patient (1). In the following contribution the focus will be on the challenges biopharmaceuticals offer to the formulation scientist.


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By Dr Michael I Ugwoke, Scientist Formulation Development/Project Leader at OctoPlus Development BV and Professor Daan JA Crommelin, Dean of the Faculty of Pharmaceutical Sciences, Scientific Director of the Utrecht Institute for Pharmaceutical Sciences (UIPS), and Scientific Director at OctoPlus Development BV.

Dr Michael I Ugwoke is a Scientist Formulation Development/Project Leader at OctoPlus Development BV. He is responsible for design and execution of sponsored projects within the company. Since joining OctoPlus, he has specialised in the development of particulate advanced drug delivery systems and the freeze drying of biopharmaceuticals.

Mike obtained a degree in Pharmacy from the University of Nigeria Nsukka and a PhD in formulation development of particulate systems for administration in the upper respiratory tract from the University of Leuven, Belgium.


Professor Daan Crommelin is a Full Professor at the Department of Pharmaceutics at Utrecht University. He is Dean of the Faculty of Pharmaceutical Sciences, Scientific Director of the Utrecht Institute for Pharmaceutical Sciences (UIPS) and Adjunct Professor at the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah. His research is focused on advanced drug delivery and drug targeting strategies. He has published over 240 articles in peer reviewed journals.

Professor Crommelin is also Scientific Director of OctoPlus, a Leiden based company specialised in the development of pharmaceutical product formulations and advanced drug delivery systems. He is European Editor of Pharmaceutical Research and is on the editorial board of 10 peer-reviewed journals in the pharmaceutical sciences.


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Dr Michael I Ugwoke
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Professor Daan Crommelin
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