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1.
Int J Pharm ; 496(2): 421-31, 2015 Dec 30.
Article in English | MEDLINE | ID: mdl-26456268

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.


Subject(s)
Antibodies, Monoclonal/chemistry , Cell Line , Chromatography, High Pressure Liquid , Drug Stability , Drug Storage , Dynamic Light Scattering , Guideline Adherence , Humans , Hydrogen-Ion Concentration , Protein Structure, Secondary , United Kingdom
2.
Bioorg Med Chem Lett ; 19(6): 1749-52, 2009 Mar 15.
Article in English | MEDLINE | ID: mdl-19217283

ABSTRACT

Drug-like molecules with activity against Trypanosoma brucei are urgently required as potential therapeutics for the treatment of African sleeping sickness. Starting from known inhibitors of other glycosyltransferases, we have developed the first small molecular inhibitors of dolicholphosphate mannose synthase (DPMS), a mannosyltransferase critically involved in glycoconjugate biosynthesis in T. brucei. We show that these DPMS inhibitors prevent the biosynthesis of glycosylphosphatidylinositol (GPI) anchors, and possess trypanocidal activity against live trypanosomes.


Subject(s)
Chemistry, Pharmaceutical/methods , Mannosyltransferases/antagonists & inhibitors , Mannosyltransferases/chemistry , Trypanosoma brucei brucei/enzymology , Trypanosomiasis, African/drug therapy , Animals , Crystallography, X-Ray/methods , Drug Design , Drug Evaluation, Preclinical , Ethanol/chemistry , Humans , Models, Chemical , Molecular Conformation , Molecular Structure
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