Evaluation of the physiochemical 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

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)

Abstract

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.
Original languageEnglish
Pages (from-to)421-431
Number of pages11
JournalInternational Journal of Pharmaceutics
Volume496
Issue number2
Early online date8 Oct 2015
DOIs
Publication statusPublished - 30 Dec 2015

Keywords

  • Remsima
  • Infliximab
  • Biosimilar
  • Antibody
  • Shelf-life
  • Extended storage
  • Compliance
  • Stability study

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