Injectable drug delivery: How to reduce time and risk in your project development
Sponsored by: Aptar Pharma
- Injectable Drug
- Elastomeric Component
- Coated Stopper
- Vial Compatibility
Date: 22 October
Time: 3.30PM London/4.30PM Paris/10.30AM New York
How high quality, film and coated elastomeric stoppers can accelerate and derisk your development
The race to develop vaccines and treatments for COVID 19 has re-emphasized the need to de-risk and accelerate packaging development for injectable drugs.
The risk does not just relate to the patient, but also regulatory risk that impacts quality and potentially the bottom line. No company wants to find its drug product listed on the FDA Recalls list due to contamination i.e. the presence of particulates, and yet, 11% of drug recalls in 2018 were due to foreign materials.
As formulations become more sensitive, the selection of elastomeric components that adapt to manufacturing processes as well as meet compatibility expectations, is a critical component in the product lifecycle.
In this webinar, we will discuss how high-quality film coated injectable components meet compliance expectations and maintain safety of supply for your drug product. This presentation will highlight how a proprietary film coating approach can improve product robustness and facilitate the development of a packaging solution for an injectable drug.
We will discuss how elastomeric components are the major contributor to leachables in the drug product and review how a coated stopper solution mitigates the presence of leachables in the formulation, not only preventing compatibility issues but also minimizing toxicity.
We will also review the results of a migration study performed over a 12 month period, which evaluated the impact of sterilization methods on the potential leachables from different coated and uncoated stoppers from different suppliers.
We will assess the impact of the choice of stopper on other properties such as the vial compatibility and other functional properties, and from a manufacturing standpoint, review how continuous process improvements have been implemented that reduce contamination to achieve a 1.3 PCI specification. In addition, 100% inspection via visual systems helps prevent defects from entering the supply chain.
By introduction of quality through technology, we will demonstrate the attributes of how film coated elastomer components improve managing component selection in a quality risk management environment.
Regional Market Development Manager, NAM
Arnaud Fournier is Senior Business Project Manager for Aptar Pharma. A graduate from IPAG Business School Paris, with a specialization in Marketing, he joined Aptar Pharma in 2004 as Marketing Project Manager. Arnaud then moved into Business Support and promotes Aptar Pharma’s range of elastomeric components for vials and Pre-Filled syringes. He is involved in new product development, especially PremiumCoat®, within Aptar Pharma’s coated range of products.
Julie D. Suman,
President, Next Breath, an Aptar Pharma Company
Julie D. Suman, R.Ph., Ph.D is the Founder of Next Breath, an Aptar Pharma business, and serves as its President. Dr. Suman holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). Dr. Suman is co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University. She is also a licensed Maryland pharmacist. Dr. Suman has published her research in peer-reviewed journals and has been presented during podium sessions at international meetings at the FDA Topics in Bioequivalence Seminar Series and has been an invited speaker at ANVISA in Brazil. Dr. Suman is also a member of the Parental Drug Association Visible Particulate Taskforce.
Director of Sales and Marketing, Gateway Analytical, an Aptar Pharma Company
Mr. Scatena has been with Gateway Analytical since 2010 and was responsible for helping establish their particulate identification laboratory. He has held the roles of scientist and laboratory manager, responsible for the day-to-day operations of the laboratory and the investigational testing for pharmaceutical clients. Today, Mr. Scatena oversees sales and business development operations and works as a scientific liaison between pharmaceutical clients and the laboratory for particulate matter and container closure investigations and testing. Mr. Scatena holds a Bachelor’s Degree in Biochemistry.
Key Learning Objectives
- How high quality film coated components address regulatory requirements
- How to de-risk component selection process
- Understand how process improvements can reduce contamination
- Evaluate the impact of steam and gamma sterilization on elastomer components
- CMC Scientist
- Director/Manager of Quality
- Director/Manager Drug Delivery
- Director/Manager/Team leader of R&D
- Analytical Chemists
- Director/Manager of Pharmaceutical Development
- Director/Manager/Team leaders of Formulation Development
- Manufacturing Scientist
- Director/Manager of Clinical Manufacturing
- Director/manager of Outsourcing