Evaluating risk to the product dominates injectable drug development discussions. 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
Presented by Adam Shain, Director, Global Business Development – Injectables, Aptar Pharma and Dr. Julie D. Suman, President, Next Breath, an Aptar Pharma company, this webinar discusses how high quality film coated elastomeric stoppers reduce patient and regulatory risk
Evaluating risk to the product dominates injectable drug development discussions. Risk not only means risk to the patient, but regulatory risk that impacts quality and possibly the bottom line. No company wants to find its drug product listed on the FDA Recalls list due to contamination such as the presence of particulates. Yet 11% of drug recalls in 2018 were due to foreign materials. As formulations become more sensitive, selection of elastomeric components that adapt to manufacturing processes as well as meet compatibility expectations are also a critical aspect of the product lifecycle. It took more 2 years to address a leachable interaction between an uncoated elastomer plunger and an erythropoietin formulation after it was withdrawn from the EU market and another four year commitment of immunogenicity monitoring to overcome this issue.
In this webinar, we discuss how high quality film coated injectable components meet compliance expectations and maintain safety of supply for your drug product. This presentation highlights how a proprietary film coating approach improves product robustness. From a manufacturing standpoint, 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.
Elastomeric components are the major contributor to leachables in the drug product. A coated stopper solution mitigates the presence of leachables in the formulation preventing not only compatibility issues but also minimizing toxicity. A migration study was performed to evaluated potential leachables from both steam and gamma irradiated coated components. The results from this study, which demonstrated comparability in leachable profiles, is presented during this webinar.
Presented By
Adam Shain
Director, Business Development, Global Digital Healthcare Systems
Adam Shain is responsible for driving the new business agenda with pharma, payers and hospital network partners to reinforce the division’s leadership in the digital healthcare space. Adam previously worked for Promius Pharma, a subsidiary of Dr Reddy’s Laboratories, where he was instrumental in the development, commercialisation, and launch of many of its branded combination products.
Dr. Julie D. Suman
PhD, President, Next Breath, an Aptar Pharma Company
Julie holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a 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. Julie is a Past-Chair of the AAPS Inhalation Technology Focus Group. She is also a licensed Maryland pharmacist. Julie has published her research in peer-reviewed journals, has presented during podium sessions at international meetings such as the FDA Visiting Professor Lecture Series, and has been an invited speaker at ANVISA in Brazil. Dr. Suman’s doctoral research, which focused on the relationship between in vitro tests for nasal sprays and in vivo deposition, has been recognized for excellence by a research award presented at the International Society for Aerosols in Medicine, 2001.
