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  4.  » A Stagewise Approach to High Potency Drug Product Clinical Development & Commercialization

​A Stagewise Approach to High Potency Drug Product Clinical Development & Commercialization

Date: December 8, 2022
Time: 11am EST  |  4pm GMT  |  5pm CET

High potency drugs are increasingly prevalent in the drug development pipeline. While highly potent compounds have benefits in treating medical conditions such as cancer, rare diseases etc., companies with promising high potency active pharmaceutical ingredients (HPAPIs) can face significant challenges in developing and bringing these innovative medicines to market. This is specially the case for virtual, small, mid-sized biopharmaceutical companies. Key challenges revolve around phase appropriate containment systems that ensure workers and the environment are protected, along with demonstrable and adequate controls to mitigate cross-contamination risks in a multi-purpose environment.

Some drug sponsors/developers do not always understand what potency implies or what it means to their proposed processes at a selected CDMO site. They may not know how much or what type of containment is needed and its impact on the development, scale-up and/or commercial manufacturing processes.

This webinar will examine:

  • Selection of level of containment needed for HPAPIs
  • Phase appropriate development to support early and late phase clinical demands at the same site
  • Impacts of using containment for product development activities
  • Strategies to control cross-contamination in multi-purpose facility

Catalent Greenville has developed and implemented a robust new product introduction (NPI) process that utilizes a broad cross-functional approach that brings together EHS, QA, product development and operations to drive consistency and thoroughness in choosing the optimum containment systems that protect people and prevent cross-contamination when introducing an HPAPI onsite.

FEATURED SPEAKERS

 

Thomas B. “Brad” Gold, PhD
Head of Pharmaceutical Development
Catalent

 

 

Anshul Gupte, PhD, RA-Drugs
Senior Director, Scientific and Technical Affairs
Catalent