title: Evaluation of the physicochemical and functional stability of diluted REMSIMA® upon extended storage--A study compliant with NHS (UK) guidance.
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.
authors.affiliation: Department of Pharmacy & Pharmacology, University of Bath, Claverton Down, Bath BA2 7AY, United Kingdom.
authors.forename: Benjamin L
authors.initials: BL
authors.lastname: Young
authors.affiliation: Bath ASU, Unit A15 Fiveways Light Industrial Estate, Westwells Road, Corsham SN13 9RG, United Kingdom.
authors.forename: Monika Ali
authors.initials: MA
authors.lastname: Khan
authors.affiliation: Department of Pharmacy & Pharmacology, University of Bath, Claverton Down, Bath BA2 7AY, United Kingdom.
authors.forename: Terry J
authors.initials: TJ
authors.lastname: Chapman
authors.affiliation: Bath ASU, Unit A15 Fiveways Light Industrial Estate, Westwells Road, Corsham SN13 9RG, United Kingdom.
authors.forename: Richard
authors.initials: R
authors.lastname: Parry
authors.affiliation: Bath ASU, Unit A15 Fiveways Light Industrial Estate, Westwells Road, Corsham SN13 9RG, United Kingdom.
authors.forename: Maria A
authors.initials: MA
authors.lastname: Connolly
authors.affiliation: Department of Pharmacy & Pharmacology, University of Bath, Claverton Down, Bath BA2 7AY, United Kingdom. Electronic address: a.watts@bath.ac.uk.
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Watts
mesh_terms: D000911:Antibodies, Monoclonal / Q000737:chemistry*; D002460:Cell Line; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D000067493:Dynamic Light Scattering; D019983:Guideline Adherence; D006801:Humans; D006863:Hydrogen-Ion Concentration; D017433:Protein Structure, Secondary; D006113:United Kingdom
chemical_list: D000911:Antibodies, Monoclonal; C000591237:CT-P13
keywords: Antibody; Biosimilar; Compliance; Extended storage; Infliximab; Remsima; Shelf-life; Stability study