Biologies drug substance stability

To avoid or limit problems in this area after submission of the NDA, the validation of analytical methods and the conduct of stability studies should be planned from the initial phases of clinical research. This will provide the type of data approvable by FDA. The reader is directed to the Guideline for Stability Studies for Human Drugs and Biologies and the final ICH Guideline for the Stability of Drug Substance and Drug Product for assistance in fulfilling this essential requirement. 

Despite their favourable properties, peptide-based drugs are under-represented in the pharmaceutical market. This discrimination is usually due to their poor bioavailability, which sometimes necessitates non-oral administration or even special medical devices such as inhalers. Another related major disadvantage of peptides is their low metabolic stability due to proteolytic degradation, hi addition, costs of goods for the drug substance are sometimes tremendous. Therefore, there is considerable interest to transform the active principle of biologically active peptides into small molecules with improved pharmacokinetic properties, hi this chapter, we present an overview of... 

The U.S. FDA provides a detailed description of the characterization of the substances obtained by recombinant DNA technique. The details are provided in the website mentioned in Ref. 3. In addition, several guidelines of the ICH and other guidelines at the U.S. FDA provide additional information on stability testing of biological products. What follows in the successive paragraphs is an outline of what constitutes the required minimum studies. A drug substance is... 

Q3A Impurities in New Drug Substances (Issued 2/10/2003, Posted 2/10/2003) Q3B(R) Impurities in New Drug Products (Issued 11/2003, Posted 11/13/2003) Q5C Quality of Biotechnological Products Stability Testing of Biotechnological/ Biological Products ... 

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