Amish Patel

Amish Patel

Emergent Biosolutions, USA



Biography

Dr. Patel is the Senior Director of Product Development at Emergent Biosolutions (USA). He is responsible for developing oral and injectable delivery platforms and process for vaccines. He has developed process, formulation and delivery system for small molecules, DNA vaccines, Virus Like Particle vaccines (VLP), cell therapy, Adenovirus and Bacterial vaccines from development to GMP manufacturing. Dr. Patel CMC experience ranges from pre-clinical to life cycle management with successful track record of commercialization of the biologics. He has been an integral part of the QA, QC and GMP manufacturing teams where he has developed over 15 clinical products and trained the GMP staff on the production technology. Prior to PaxVax, Dr. Patel worked as a Senior Scientist II, doing Formulation Research at NexBio Inc. and as a Sr. Scientist at MicroIslet, Inc where his primary responsibilities involved developing process and formulations for encapsulating cells (islets) for in vivotransplantation. Dr. Patel received his Ph.D. and M.S. in Chemical Engineering with special interest in Nanotechnology field, from Louisiana Tech University, and, B.S. Chemical Engineering from University of Poona (India)

Abstract

Unlike conventional formulation development, delivery platform and late stage formulation focus more on the control of delivery technology for dosage forms. Conditions to keep the desired potency of vaccine  before and during the administration is equally important.
Poor delivery platform will cause significant potency loss of vaccine during the administration no matter how great of shelf-life the product has, so Scientists working in the formulation field should consider the delivery route as a critical factor in developing their product and design the formulation and delivery study to support it or could see failure in the animal study, clinical study and impact the future of the project
More attention should be given for the delivery platform and late stage formulation development for all dosage forms