Course Description

Lyophilization Technology

This course is currently at capacity or unavailable for registration, please contact Customer Service at (732)613-4500 or info@cfpa.com for more information.

Course ID 279

In-Person Course

Who Should Attend?
This course is designed for personnel in the pharmaceutical, diagnostic, biomedical engineering and biotechnology industries responsible for the specification, development and production of lyophilized products, including:

  • R&D Personnel
  • Chemists
  • Pilot Plant Operations
  • Chemical Engineers
  • Production Supervisors
  • Microbiologists
  • Managers
  • Pharmacists
  • QA/QC
  • Project Management
  • Regulatory Affairs

Those new to the industry and those with previous experience will find the course beneficial.

Course Description
This course presents the principles and techniques of lyophilization based on theoretical concepts and practical examples. Scientific aspects of aqueous systems, phase transitions, collapse phenomena are explained. Emphasis on pharmaceutical aspects including formulation, stability, cycle development, process scale-up and analytical instrumentation is provided. Regulatory requirements including cGMPs, validation and qualification will be discussed. Engineering elements of heat and mass transfer, process control, and lyophilizer qualification are reviewed as well. The principles presented will be related to practical industrial examples throughout the course.

Course Director
Dr. Madhav Kamat, Ph.D., R. Ph.; Independent Pharmaceutical Consultant

Dr. Madhav Kamat is an independent pharmaceutical consultant having 25 years of sound industrial experience specializing in the area of injectable products and processes. Dr. Kamat has a significant experience in product/process development (small molecule and biologicals) involving formulation development, lyophilization, scale-up/technology transfer, and sterile manufacturing of more than 20 injectable products. He is well recognized for his expertise in the lyophilization, nanosuspension technology, aseptic technology, and other sterile manufacturing processes. His recent interests are formulation and process development of biological products and IV injectable products of water insoluble drugs. Dr. Kamat received his B. Pharm and M. Pharm from Bombay University and Ph.D. from the College of Pharmacy at University of Kentucky, USA. Dr. Kamat’s Ph. D. dissertation was based upon lyophilization technology and he has authored many publications on sterile products and lyophilization. Dr. Kamat worked at Bristol-Myers Squibb Company for the last seventeen (17) years in Technical Operations and R&D–most recently as a Director. Prior to BMS, Dr. Kamat worked at Centocor Inc. and Johnson & Johnson. Dr. Kamat has been a visiting professor at the College of Pharmacy, University of Kentucky and at New Jersey Institute of Technology, NJ. Dr. Kamat is also a Registered Pharmacist in the States of Pennsylvania and New Jersey.

Additional Faculty
Mukund “Mike” Yelvigi, Principal and Managing Partner, Center for Pharmaceutical Integration, LLC. New Jersey

Notify Me When Course Is Scheduled