Small molecule drug developers continue to realize the strong therapeutic potential of highly potent active pharmaceutical ingredients (HPAPIs), particularly in areas such as oncology. With this demand comes a critical need for safe manufacturing and containment technologies to produce high quality products. Micronization is a proven and widely used technology to address bioavailability and manufacturability challenges facing highly potent oral drugs. 

Development of HPAPIs presents unique challenges for product containment and requires special consideration in equipment selection, operating procedures, and safety processes. This webinar will discuss how to classify HPAPIs in early development and share recommendations for safe product handling, from clinical manufacturing to commercialization. The speakers will also share the key advantages of using micronization technology for the development and manufacturing of HPAPIs.

Key Learning Objectives:

  • Understand the key data points required for evaluating and classifying highly potent APIs
  • Review associated occupational exposure limits and handling recommendations 
  • Gain insight into the benefits of HPAPI manufacturing using micronization 
  • Learn about facility set up, engineering controls and how to incorporate flexibility in manufacturing various batch sizes
  • Considerations in selecting a partner with robust expertise in micronizing HPAPIs

Featured Speakers

Phil Swanston

General Manager, Dartford
Catalent

Phil Swanston is the General Manager of Catalent’s Dartford, UK micronizing facility, which specializes in particle size reduction technologies and integrated analytical services for the pharmaceutical industry. Mr. Swanston joined Catalent in 2020, and in his current role is responsible for the overall operations, quality, compliance, execution and administration of the Catalent Dartford site.

Prior to joining Catalent, Mr. Swanston worked at GSK for over 20 years where he held various roles of increasing leadership responsibility across multiple functions including production operations, supply chain, distribution, logistics, packaging and project management. Most recently, Mr. Swanston held the role of Production Director at the GSK state-of-the-art Oral Solid Dose, Respiratory and Micronizing manufacturing facility in Ware, UK. Throughout his time at GSK, Mr. Swanston played a pivotal role in leading teams through significant transformational and cultural changes whilst improving capability, people / product development, business performance and employee engagement. Mr. Swanston holds a Bachelor’s in Engineering from the University of Salford in Salford, UK.

Tracy A. Kimmel, Ph.D., DABT 

Principal Toxicologist
SafeBridge Consultants, Inc.

Dr. Kimmel is currently Principal Toxicologist for SafeBridge Consultants, Inc. She has over 25 years of experience in the pharmaceutical industry, where she worked in various capacities in corporate occupational toxicology groups, culminating as a Manager of Hazard Assessment and Characterization at Pfizer Inc. Her primary responsibilities have included: management of programs for setting of Occupational Exposure Bands and health-based exposure limits for commercial and proprietary drug substances and other chemical compounds; communication of health hazard information to company facilities worldwide; development and maintenance of Material Safety Data Sheets; performing qualitative hazard assessments of pharmaceutical synthetic intermediates; assisting with environmental risk assessments; and monitoring of toxicology studies for worker safety. Dr. Kimmel is a Diplomate of the American Board of Toxicology since 1998 and is a member of ACGIH's TLV® Committee.  She is a member of the Society of Toxicology, National Chapter and Lake Ontario Regional Chapter. Dr. Kimmel is a guest lecturer on regulatory toxicology and toxicity testing methods at New York University Medical Center/Graduate School of Arts and Sciences.

Date:  Tuesday, October 12, 2021
Time:  11am ET / 8am PT
Duration:  1 Hour

Register now for this webinar