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

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

 

Overview

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

Tracy A. Kimmel, Ph.D., DABT 
Principal Toxicologist
SafeBridge Consultants, Inc.