Speaker Bios and Abstracts
"The Impact of Deep Cold Storage Conditions on the Container Closure Integrity of Parenteral Vials"
Roger Asselta, Vice President (VP) of Technical Affairs, Genesis Packaging Technologies
Roger has 30 years working in the field of injectable drug packaging. In 2006, he joined Genesis Packaging Technologies as (VP) of Technical Affairs and Senior Advisor in 2008. Since 2009, Roger has been an active PDA member and volunteer. Roger leads the Parenteral Packaging Science Interest Group on PDA's pharmaceutical discussion forum - PDA Connect. As an Education Instructor, he has presented training courses globally on Container Closure, Pharmaceutical Packaging, and Glass Handling.
In 2017, Roger was awarded the Edward Smith PDA Packaging Science Award, for his contributions toward the advancement in the Pharmaceutical Packaging Science industry.
Roger earned a Bachelors of Science degree in Biology from Nasson College and received a Graduate certification in Quality Management from Pennsylvania State University
Advancement in the Cell and Gene therapies has grown significantly in the last several years.
These bio-pharmaceuticals classes present challenges to the Container Closure Systems used for their packaging and storage.
This presentation will discuss some of the challenges with Parenteral Vials concerning the frequently demanded Deep Cold Storage of these therapies and some of the work being done to meet those challenges.
"A Challenge with Single-Use Technology: Protecting Bulk Drug Substance during Cold Chain Handling, Storage and Transport"
Joe Cintavey, Product Manager, Gore PharmBIO Products
Joe is responsible for Product Management for Gore PharmBIO, a business within Gore that is focused on the pharmaceutical and medical device OEM markets.
For the last several years, he has been working on a new product line centered on protecting bulk drug substance during Cold Chain handling. Before Gore PharmBIO, Joe worked as a Connection Systems Product Manager in the automotive industry.
Joe holds a Bachelor of Science in Mechanical Engineering (BSME) and Masters of Business Administration (MBA) from the University of Connecticut.
The issue of Single-Use Container durability during Cold Chain handling is well known in the bio-pharmaceutical market, particularly at freeze and transport temperatures down to -80 degrees Celsius.
The extractables and leachables profile of materials commonly used in containers is another concern.
This presentation will discuss novel technologies that address both the durability and purity challenges that bio-pharmaceutical manufacturers face.