Graham is a Senior Consultant with 30 years of pharmaceutical development experience in physicochemical characterization

He is an experienced scientific leader with a proven track record for understanding and resolving complex technical issues throughout the product life-cycle for both drug substance and drug product including inhaled, semi-solid, liquid and solid dosage forms.

Graham Whitesell

Graham’s expertise is in the integrated use of multiple analytical techniques for the efficient physicochemical characterization of drug substance and drug products in support of resolving complex technical issues throughout the pharmaceutical lifecycle including the selection of development candidates, all phases of product development, scale-up, technology transfer and manufacture of marketed products. Over the years he has supported numerous development projects, led cross-functional project teams, authored regulatory applications, responded to regulatory questions and been a corporate resource for solving technical issues.

Graham has a Ph.D. in Physical Organic Chemistry from Emory University, USA and a B.S in Chemistry from the University of North Carolina in Chapel Hill, USA. He currently lives in the Research Triangle area of North Carolina, USA.

Examples of projects completed:

  • Identified the root cause of dissolution failures in the NDA stability batches of a semisolid-filled soft-gel capsule. Planned and led processing and materials characterization experiments to define the product’s appropriate manufacturing and storage control spaces. The knowledge gained was also applied to existing marketed products.

  • Provided materials characterization expertise and laboratory support to a world-wide, multi-site process and physicochemical property mapping of a $1 billion+ per year product. The knowledge generated is utilized to evaluate the impact of future changes to the API and product manufacturing processes.

  • Developed and applied spectroscopic methods to determine the root cause of sporadic leaking of a commercial metered dose inhaler (MDI) product preventing the product’s recall. Identification of the root cause allowed the implementation of appropriate control measures.

  • Provided material characterization expertise for the development of a dry powder inhalation (DPI) product which utilized API conditioning to remove amorphous content and fines to provide improved fine particle mass stability of the formulated product. The product was approved and launched in multiple countries.

  • Identified physical instability of a semi-solid ointment and determined its cause. Worked with formulator to identify alternative excipients to produce a stable, robust product.

  • Determined the mechanism responsible for limiting the bioavailability of a new class of NCE’s approaching candidate selection and identified a formulation approach to overcome the bioavailability issue.

  • Established and led a cross-functional international team focused on identifying best practices for the preclinical evaluation and pharmaceutical development of poorly absorbed and low solubility API’s.

  • Provided leadership and technical expertise to multi-site cross-functional teams of particle scientist, analyst and engineers for the development and implementation of 1st intent workflows for particle size reduction and powder flow.