Subscribe to Newsletter
Discovery & Development Formulation, Quality & Compliance, Standards & Regulation, Bioprocessing - Upstream & Downstream, Technology and Equipment, Small Molecules, Bioprocessing - Single Use Systems, Technology and Equipment, Analytical Science

Therapeutic protein products used for the differentiation and characterization of subvisible particulates

Introduction

The formation of protein aggregates is a particular concern for parenteral administration biopharmaceuticals due to the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for companies to monitor and, if required, reduce the levels of sub-visible particles present in therapeutic protein from manufacture through their complete shelf life. While immunogenicity can be induced by a variety of mechanisms, contamination by non-protein material is known to be a potential cause. The presence of silicone oil in parenterals has attracted considerable interest, due to its use in syringe-based administration systems and the difficulty in distinguishing oil droplets from protein aggregates. In addition to protein aggregates, non-biological contaminants may act as nucleation points for aggregate growth. Consequently, particle sizing alone is not sufficient.

Receive content, products, events as well as relevant industry updates from The Medicine Maker and its sponsors.
Stay up to date with our other newsletters and sponsors information, tailored specifically to the fields you are interested in

When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected].
If you wish to unsubscribe, you can update your preferences at any point.

  1. Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (2013): FDA
  2. Code of Federal Regulations; CFR21, Part211.65
  3. Characterization and Quantitation of Aggregates and Particles in Interferon-β Products: Potential Links Between Product Quality Attributes and Immunogenicity (2013): J. Pharm. Sci. (102) p.915
Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

Register