Andrew Lee

Senior Consultant - Analytical Chemistry

• Over 25 Years experience working within the pharmaceutical industry at Contract Research Organisations supporting clients with R&D and regulatory submission projects in support of OINDP, solid oral doses, opthalmics, injectables, and protein based biologic dosage forms
• Over 20 years experience in the development and validation of analytical methods to support GxP studies for product characterisation, clinical dose efficacy and registration stability
• Over 15 years of experiences designing and performing Extractables and Leachables studies to support product design, risk mitigation, patient safety assessments and regulatory submissions

Andrew Lee is a subject matter expert for Extractables and Leachables at Broughton. He has over 25 years experience developing and validating methods within the pharmaceutical industry, with a specialism in developing, designing and implementing Extractables and Leachables studies in support of material selection, product packaging design, and final product safety assessments.

He has extensive experience with controlled extraction studies, to understand the extractables profiles of the product packaging and identify target Leachables. He has expertise in developing and validating tailored analytical methods for the analysis of Leachables, to determine the Leachables characteristics of the product; advising the clients risk mitigation strategies and ensuring that products are safe for patient to use through to shelf life

In his previous roles, he developed a broad understanding of the pharmaceutical industry, and the analytical techniques used to support the Chemistry Manufacturing Controls aspects of product development. He has worked on projects covering many phases of development within good manufacturing practice (GMP) departments to provide the highest quality data possible to support product characterisation, QC release, registration stability and regulatory submissions for solid oral dosage, inhaled, nasal delivery products, ophthalmic and injectable dosage forms.

He holds a First Class Batchelors degree from the University of Huddersfield in Analytical Chemistry. His career has seen a primary focus on helping his clients deliver the highest quality and safest products to market.