ANALYTICAL DEVELOPMENT, PREFORMULATION/FORMULATION, AND DRUGS’ SPECIFICATIONS: WHY THESE STEPS SHOULD BE CLOSELY CONNECTED?
Pascal St-Laurent* and François-Xavier Lacasse
ABSTRACT
Each new molecular entity (NME) or active pharmaceutical ingredient (API) is unique. Whether the molecule to be developed is a chemical (small molecule, peptide,..), a polymer, a biologic (polypeptide, protein, immunoglobulin,….) each of this entity will have to be developed under the same lot after lot irrespective of the scale in order to obtain the same physical, chemical and biological behaviors. Over the last decades, with the constant growth of small biotech companies came a paradigm shift in the business model. Since these companies were not necessarily strong enough (money and human resources) to launch a drug product, a new model was adopted to narrow down the risk. To summarize, ideally, the goal was to reach phase IIa clinical trial to generate clinical results (therapeutical exploration) and to license the molecule out to a partner, that would streamline the development through phase 3 and eventually commercialize the NME as a drug product. But, as mentioned, the above represents an ideal scenario. More than often, in the quest of the nanomolar efficiency, these young sponsors forgot the “druggability” and the overall reproducibility of their compounds, the reliability that analytical, preformulation/formulation development and specifications, even though they could have been surrounded by seasoned drug professionals referring to their proven track records, connected with reliable documentations such as pharmacopeia and guidelines. Authors of this short communication combine more than 50 years of drug development and will try to illustrate that science will never be better than regulatory requirements, regardless of drug indication.
[Full Text Article] [Download Certificate]