Rational formulation development is based on the thorough understanding of the molecular properties of the experimental therapeutic, and how it behaves in pharmaceutically and biopharmaceutically relevant environments. Therefore, it is essential to have analytical and bioanalytical tools that measure these properties, after which experiments can be designed to answer specific questions. Physicochemical characterization provides molecular insight about the therapeutic compounds, identifies liabilities, and informs formulation and process development. ADME/PK studies also inform formulation development to facilitate control over bioavailability and metabolic characteristics. Wolfe Laboratories' scientists integrate their knowledge of interdependent scientific disciplines and utilize state-of-the-art facility and business practices to address the rapidly changing needs of early development programs. Not all activities are needed for each molecule, and the specific experiments can vary depending upon the issues of a given molecule. This rational approach advances a de-risked candidate into clinical studies, or otherwise allows for timely identification of liabilities and cost-containment. In general, the aspects that must be addressed include:
Analytical methodologies provide molecular insight regarding the attribute being studied.
Physicochemical properties are characterized during the preformulation process.
Biopharmaceutical properties (permeability, partition coefficient, plasma protein binding, metabolic stability, metabolite ID, etc.) inform formulation development and are evaluated in parallel with preformulation.
Rational formulation development integrates the knowledge gained regarding the pharmaceutical and biopharmaceutical properties, and includes assessment of performance in biorelevant media.
Types of formulations include oral, injectables, topicals, and other dosage forms.
Types of molecules include small molecules, peptides, proteins, small molecule-macromolecule hybrids, high potency, cytotoxic, and controlled substances.
In-house manufacturing to support preclinical studies and sub-contracting of clinical trial material manufacturing
cGMP release and stability testing
GLP and non-GLP bioanalytical testing
Wolfe Laboratories integrates these relevant functions during early drug development to ensure that de-risked, drug-like molecules are advanced into the clinic, and that molecules with unsuitable properties are identified before scarce resources are expended on their development.