Alan joined Broughton having previously designed and performed Extractables and Leachables studies for pharmaceutical regulatory applications.
Alan Hutchinson is the subject matter expert for Extractables and Leachables at Broughton. He has over 10 years of experience specializing in Extractables and Leachables testing. His Education background includes a Higher national diploma in chemistry from the University of Huddersfield. His goal has always been to ensure the safest product for the consumer/patient.
Alan’s career has primarily been in the pharmaceutical industry. At GlaxoSmithKline, he gained a broad knowledge of analytical techniques and product development, working on projects through various phases of development within GMP departments. With the aim to provide the best data possible for regulatory submissions.
Early in his career, he worked to generate high-quality stability data for regulatory submissions for solid oral dose products and oral solutions for European and US applications. Later in his career, Alan moved to inhaled dose products and, more recently, biopharmaceutical and cell and gene therapy products. For the last 10 years specializing in extractables and leachables of pharmaceutical products.
As part of the Extractables and Leachables team at GlaxoSmithKline, Alan designed and produced high-quality data sets to present key knowledge and understanding of extractables, leachables, mutagenic, and elemental control strategies as a robust approach to risk mitigation. These data sets supported product safety and registration for a portfolio of small molecules, biopharmaceutical, and cell and gene therapy projects. He is experienced in developing and validating trace analysis methods using GC and LC with a range of detection techniques, including MS, FID, and QToF to the regulatory and industry guideline requirements.
Alan is experienced in performing risk assessments to identify the source and probability of potential leachables and, from these, create mitigation plans for the container closure system and the manufacturing process as part of a regulatory submission or product development.
