UK Derived & Manufactured Dried Plasma Component

Tender description

This Prior Information Notice (PIN) is presented on behalf of National Health Service Blood and Transplant (NHSBT). This PIN intends to understand the market interest in relation to the Feasibility of a UK Derived & Manufactured Dried Plasma Component (DPC).<br/>This Prior Information Notice (PIN) is separate to any tender opportunity and not <br/>related in any form whatsoever to any subsequent activity that NHSBT may wish to pursue. <br/>The purpose of this PIN is to inform the market of NHSBT’s intention to improve NHSBT’s knowledge on the status of manufacturer(s) or economic operator(s) that can supply a UK derived and manufactured Dried Plasma Component (DPC). <br/>In addition, NHSBT would like to gauge market interest in the provision of this new product and understand the willingness of the market to form a strategic partnership and a collaboration with NHSBT in order to ensure that the DPC has an approved CE/UKCA mark for use of the DPC within the UK market. Lot 1: NHSBT requires a direct and enhanced contractual relationship with either a manufacturer or an economic operator for a complete end-to-end integrated solution for a UK derived and manufactured dried plasma component (DPC). The solution must include all the necessary product research, design and development, product specification creation, manufacturing (pilot and scale-up), clinical trials, equipment provision, installation, planned and preventative maintenance, consumables, reagents, software including an interoperability provision with NHSBTs existing IT infrastructure and data sharing mechanisms, and overall on-going support provision for the safe and effective operation of the end-to-end solution in a real time operational environment. <br/>The manufacturer(s) or economic operator(s) may already have this integrated solution and technology either fully or partially developed and must be willing to commit to a transparent, collaborative working relationship with NHSBT to produce a UK derived and manufactured DPC product for initial use within the domestic market.<br/>Furthermore, the manufacturer(s) or economic operator(s) must be willing to co-develop a DPC specification and undertake laboratory studies to demonstrate that the final product meets all UK requirements for a CE/UKCA mark.<br/>NHSBT intends to offer operational and commercial support to the manufacturer(s) or economic operator(s) such as collaboratively working on clinical trials and research studies, provide access to UK collected plasma and co-write clear plans for obtaining the clinical data needed to meet UK’s clinical guidelines (or equivalent standards) for obtaining a CE/UKCA mark. <br/>It is NHSBT's intention to therefore engage with the market to understand its capabilities and interest in participating in a collaboration for this service and the desire to develop the DPC product. The format for further engagement associated with this unique programme will be communicated to those manufacturer(s) and economic operator(s) who respond to this PIN. The engagement meetings will take place on the 26th of January 2022 and 8th February 2022 and time slots will be offered on a first come first served basis and prioritised according to the level of interest demonstrated by the respondents.<br/><br/>Expressions of interest should be e-mailed to tennille.madigan@nhsbt.nhs.uk by no later than 1200 hours on 24th January 2022. Interested manufacturer(s) and economic operator(s) are requested to provide the following information: <br/><br/>• Company name <br/><br/>• Address<br/><br/>• Contact details (e-mail and a mobile number)<br/><br/>• A brief paragraph to i) summarise their company’s information outlining the principal line of business; ii) an explanation of the company’s suitability and experience to provide this new service and product to NHSBT; and iii) confirmation of the interest in participating in this highly innovative and ground-breaking collaborative programme.