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The evolving regulatory expectations for the pharmaceutical industry require early evaluation of sterile (or injectable) drug product packaging materials. Biologic drug products have seen increased growth and typically use parenteral drug packaging systems. The sensitivity of biologic/cell/gene therapy drug products drives the need to minimize the use of silicone and maximize the use of barrier films and coatings. Primary container component manufacturers have been working to improve these films and coating through multiple technologies. This webinar will discuss:

  • Market insights of biologic/cell/gene therapy drug product sensitivities that establish the need for using barrier films and coatings.
  • Scientific rationale for surface barrier technologies, comparison of processes, chemistry, and characterization techniques.
  • Case study comparison of the impact of two elastomer closures with different surface barrier technologies on a model protein, Immunoglobulin G. including differences of silicon levels and protein particle aggregation.

 

Peggy Frandolig

Peggy Frandolig

Technical Knowledge Manager, Scientific Affairs

Peggy Frandolig holds a Bachelor of Sciences in Biology from the University of Pittsburgh at Johnstown and has over 25 years of experience within the pharmaceutical industry. She currently is the Technical Knowledge Manager in Scientific Affairs where she conducts research and manages complex technical data for packaging and delivery systems and their applications, characteristics, features and claims. Peggy joined West Pharmaceutical Services in 2000, as Project Coordinator for the Analytical Laboratories; Peggy was promoted to Associate Manager of Project Management and Document Control in the Analytical Labs. She then further her career as Quality Assurance Manager, Customer Relations, her most recent position at West was Director of Technical Customer Support using her knowledge and experience working with customers to guide decisions for appropriate container closure systems for their drug products.
Fran DeGrazio

Fran DeGrazio

Chief Scientific Officer

Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry with extensive expertise in injectable drug products, including vial container closure systems and prefillable systems for combination products. Fran has held numerous technical roles at West, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories and Scientific Affairs. In her current role as Chief Scientific Officer she is responsible to leverage scientific and regulatory understanding across the enterprise. Fran received the Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Business Woman’s Association Luminary Award for West in 2017.