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Good Medicine: Solutions for Sensitive Injectable Formulations

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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to address a leachable interaction between an uncoated elastomer plunger and an erythropoietin formulation after it was withdrawn from the EU market and another four year commitment of immunogenicity monitoring to overcome this issue.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 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 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, will be presented during this webinar

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. We hope that the content of this webinar is a dose of good medicine!

Presented by

Adam Shain Director, Global Business Development - Injectables
Adam Shain is the Global Business Development Director for Aptar Pharma's Injectables division and is responsible for driving the new business agenda with a particular focus on reinforcing the division's innovation proposition. Adam had previously worked for Promius Pharma, a subsidiary of Dr. Reddy's Laboratories, where he was instrumental in the development, commercialization, and launch of many of its branded products. Prior to his position at Promius, Adam was the associate director of business development for Aptar Pharma's prescription division.
Julie D. Suman President, Next Breath, an Aptar Pharma business
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.
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October 24, 2018 3PM London / 10AM New York 60 min
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Presented by
Adam Shain Director, Global Business Development - Injectables
Julie D. Suman President, Next Breath, an Aptar Pharma business
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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
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