Evaluation of the physicochemical and functional stability of diluted REMSIMA® upon extended storage--A study compliant with NHS (UK) guidance.

Benjamin L Young, Monika Ali Khan, Terry J Chapman, Richard Parry, Maria A Connolly, Andrew G Watts

文献索引：Int. J. Pharm. 496 , 421-31, (2015)

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摘要

A newly licensed biosimilar product containing infliximab as the active pharmaceutical ingredient has recently been marketed under the brand name Remsima®. We have evaluated the stability of Remsima® diluted in sodium chloride solution and stored in polyolefin bags at 2-8°C using a range of techniques to assess the physico-chemical and functional integrity of the drug over time. The methods and techniques employed are fully compliant with NHS (UK) guidance for evaluating the stability of biologicals, enabling the data to be used for the application of an extended shelf-life to Remsima products in the UK, when prepared under a Section 10 exemption or a Specials Licence. The results clearly demonstrate physico-chemical and functional stability of the drug over the 7 day period of the study, when prepared as described here under aseptic conditions in accordance with the Summary of manufacturers Product Characteristics.Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.