Webinar: Highly Potent API Drug Product Development and Manufacturing Using Micronization Technology

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

Phil Swanston

General Manager, Dartford


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.

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

Duration:  1 Hour

Now Available On-Demand

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