There are many different drug products that are administered to humans for a variety of different medical reasons. The selection of the primary container can have a profound effect on patient adoption and compliance and for many drugs, sponsors can have a profound impact on the successful penetration of the product in the marketplace. This webinar will discuss the considerations associated with pursuing either a vial or pre-filled syringe as the primary container for your small or large molecule development programs. We will explore the development considerations around characterization and supplier selection, facility requirements, manufacturing considerations, as well as CMC considerations and regulatory requirements as a combination product intended for the US market. Attendees will leave this webinar with a clear understanding of the activities and considerations required for each alternative presentation to integrate into their development program and a fundamental understanding of the time and effort required to address each requirement.
Considerations for Vials vs. Pre-Filled Syringes
- Why do people look at syringes vs. vials?
- Target markets
- Understanding what the advantage is to your target indication
- Cost Differences
- Characterization requirements
- Delivery methods over time
- A brief history of Parenteral Vaccines
- Primary container requirements
- Compatibility considerations
- Primary container characterization
- Regulatory requirements and testing
- Evolution of types of medicines packaged
- Aseptic Manufacturing Requirements and considerations
- Applications in 2021 beyond COVID
Course Leader: Allison A. Cacciatore, Executive Director Facilities Design and Engineering
Ms. Cacciatore has over 20 years of experience in facility design, engineering, and construction management. She has served in leadership positions in several multinational corporations including Sanofi and Genzyme. She has been responsible for leading multi-million-dollar renovation projects from feasibility and conceptual design through licensure including biologic and viral vaccine facilities. Allison has overseen engineering of filling, packaging, and sterilization equipment, motion control and machine design including leading the technical oversight of the startup of a filling line during the 2009 flu pandemic. Allison has extensive experience in commissioning, qualification and validation and a deep understanding of the criteria to successfully implement Risk Based Validation and ASTM E-2500. In addition to operating organization experience, Ms. Cacciatore has been in consulting leadership roles for the past four years. Prior to her career in Pharma/Biotech, Allison was a consultant to the plastics and specialty chemicals industry. Ms. Cacciatore is a graduate of Lehigh University in Bethlehem, PA with a BS in Chemical Engineering, and MBA in Management.
Registration Deadline: 25 Mar 2021
|Student Ticket:||$100.00||— Sold Out|
|Basic Member Regular:||$210.00||— Sold Out|
|Pro Ticket Regular:||$180.00||— Sold Out|