Ensuring Parenteral Biologics’ Quality And Safety


Integrating a holistic approach toward product quality and safety in the development of biologic drug products for parenteral use.

By Hanns-Christian Mahler, Ph.D., Satish K. Singh, Ph.D., Sven Stegemann, Ph.D., all Lonza AG

Biologics, also known as therapeutic proteins, are among the most innovative novel therapies currently being developed1 and account for approximately 25–30 percent of newly launched products in the U.S. over the past 10 years.2 Biologics include, for example, monoclonal antibodies, bispecific antibodies, fusion proteins, conjugates, and any other format that is specifically designed and engineered against a clinical target to provide superior efficacy and/or safety in patients.

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July 2018

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