Wolfe Laboratories’ translational development capabilities are sought by its clients to develop extraordinarily complex molecules, as well as more traditional compounds, to advance them to early clinical studies. 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. Throughout the integrated process, Wolfe Laboratories identifies and characterizes the benefits and risks of the program, and this knowledge can be leveraged throughout a molecule’s development lifetime, saving clients significant resources.
Wolfe Laboratories’ rational, science-driven approach is based on having a mechanistic understanding of the unique physicochemical and biopharmaceutical behavior of each compound, so that the critical path activities of a development program can be highly productive. Analytical and bioanalytical methods are developed in parallel to rapidly assess relevant attributes. Knowing the route of administration and the purpose of the in-life studies, formulation development can proceed using GRAS excipients. As the compound advances and the formulation is refined, this approach obviates the need for major bridging studies. Formulations are evaluated for their physicochemical performance and behavior upon administration, using the appropriate in vitro predictive tests. Upon selection of the formulation, the drug product is manufactured, tested and the stage-appropriate stability studies are performed.
Not all activities are needed for each molecule, and the specific experiments can vary depending upon the special considerations 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 are addressed include:
- Analytical methodologies provide molecular insight regarding the attribute being studied
- Preformulation studies inform how the molecule will behave in pharmaceutically relevant environments
- 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 interdependent 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.