Research and development services and related consultancy services

Tender description

The requirement is for venous administration in support of clinical trials for a nerve agent antidote as an emergency therapy. The buffer will be a 10ml fill of a 100mM citrate buffer and the Placebo will be colour matched to a 100mg/ml solution of HI-6 in diluent. Design and manufacture of a buffer for the dilution of an intra-venous (IV) administered powder filled vial of HI-6. The Placebo is required for intra-venous administration in support of clinical trials for a nerve agent antidote as an emergency therapy. The buffer will be a 10ml fill of a 100mM citrate buffer and the Placebo will be colour matched to a 100mg/ml solution of HI-6 in Diluent. The programme will be submitted to National Regulatory Agencies in the United Kingdom, Canada and The Netherlands, and consequently, the development of these sterile products must comply with all relevant quality guidelines. This includes, manufacture and preparation of drug product, stability measurements and release activities as required. The final Diluent is intended to be treated as a medicinal product for regulatory approval and the Placebo should be suitable for use in clinical trials at all phases.