Provision of Fasudil Hydrochloride Capsules

Description

The University of Exeter requires an end-to-end solution for Fasudil Hydrochloride Capsules. The product will be used as clinical supply for a Phase IIa study. The clinical trial will likely be conducted in the USA and/or Europe (United Kingdom and Norway), therefore all formulation components and finished product must meet the regulatory requirements of USP/EP/BP and any required Norwegian pharmacopeia standards. The supplier must also comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and ensure that all supplies are released for clinical use by a duly certified Quality Person (QP). Lot 1: The University of Exeter requires an end-to-end solution for Fasudil Hydrochloride Capsules. The product will be used as clinical supply for a Phase IIa study. The clinical trial will likely be conducted in the USA and/or Europe (United Kingdom and Norway), therefore all formulation components and finished product must meet the regulatory requirements of USP/EP/BP and any required Norwegian pharmacopeia standards. The supplier must also comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and ensure that all supplies are released for clinical use by a duly certified Quality Person (QP). The supplier will undertake an evaluation of 3rd party suppliers for the procurement of the Drug Substance (DS) Fasudil Hydrochloride. It is anticipated that approximately 8.5kg of DS will be required for use in Drug Product development and manufacturing activities. This includes approximately 1kg DS for non-GMP activities and 7.5kg DS for GMP activities related to the project. The supplier will perform development activities in order to establish suitable capsule formulations for 20mg and 40mg active dose strengths and matching placebo. These development activities will include the manufacture of up to six development batches at a batch size of approximately 750g -1.5kg. The lead and back-up formulations will be subjected to a short-term stability evaluation. The purpose of this effort is to manufacture sufficient supplies of prototypes to illustrate the likely process for clinical supply, and to prepare samples for accelerated stability testing so that suitable formulations of active and placebo tablets can be identified. To fulfil clinical supply, the CTM active and placebo batches will be manufactured in three separate campaigns. First Campaign: one CTM Placebo batch at approximately 43,000 units one CTM Active 20mg dose strength batch at 6,000 units one CTM Active 40mg strength batch at approximately 40,000 units Second campaign: one CTM Placebo batch at approximately 43,000 units one CTM Active batch at approximately 40,000 units Third campaign: one CTM Placebo batch at approximately 43,000 units one CTM Active batch at approximately 40,000 units Each CTM batch will be bulk packaged, labelled (in English and Norwegian) and shipped to enable delivery of the final QP released batches to the locations requested by Client (anticipated to be in the UK and Norway, 3 or 4 sites in total). The supplier will be responsible for any customs clearance required. The supplier will be required to provide all necessary supporting services including, but not limited to, sourcing materials and the active pharmaceutical ingredient/drug substance, production, storage, labelling, packaging, quality control, qualified person release, packing, transport, loading/unloading, import/export, delivery and waste disposal.