Supply of GMP-grade custom-made reagents for Production

Description

NHSBT Clinical Biotechnology Centre (CBC) has an MHRA licence for the manufacture of sterile investigational medicinal gene therapy and recombinant protein products for clinical trials. The intended use of the reagents is for the GMP production of these types of products in manufacturing processes. Lot 1: Supply of GMP-grade custom-made reagents for Production<br/><br/>NHSBT Clinical Biotechnology Centre (CBC) has an MHRA licence for the manufacture of sterile investigational medicinal gene therapy and recombinant protein products for clinical trials. The intended use of the reagents is for the GMP production of these types of products in manufacturing processes.<br/><br/>NHSBT now wishes to commence a formal procurement process and is seeking to engage with suppliers and understand the market. <br/><br/>Business Requirements <br/>• The Supplier MUST work with NHSBT closely, to work up the Product Specification(s) for manufacturing each of the reagents and be able to provide technical knowledge where required to support the selection of materials and any pre- and post-testing requirements to best practice. <br/>• The Product Specification MUST be version-controlled and approved by both the Supplier and NHSBT for the production and Quality Control (QC) testing of the reagent. <br/>• All raw materials used MUST be of a grade compatible for the GMP reagent production in accordance with the Product Specification. <br/>• All raw materials MUST be fully traceable to the Supplier, manufacturer, and product code. <br/>• Reagents MUST be sterile filtered using a 0.2-micron sterilising-grade filter to remove bioburden.<br/>• Detailed specification will be shared while scheduling the premarket engagement call.<br/><br/>It is NHSBT's intention to hold pre-procurement supplier engagement meetings the week of 21st October 2024 to 15th November 2024. The meetings will be held remotely, the dates are to be confirmed. To enable NHSBT to finalise arrangements (e.g., send meeting details and agree time slots) for the meeting’s, interested organisations are required to send an expression of interest via email to Sahithi Bandi sahithi.bandi@nhsbt.nhs.uk by no later than 17:00 hrs (GMT) on 11th November 2024. This should include a list of your potential attendees and a brief overview (or a website link) of the Goods / Services which might be offered. Please include options, if available, for a managed service contract.<br/><br/>No business whatsoever is guaranteed under any resulting framework agreement or contract, and there is no guarantee that any framework agreement or contract will be put in place in relation to this notice. No compensation etc. will be paid if a tender or resulting framework agreement is withdrawn for any reason. Bidders should take part in this process only on the basis that they fully understand and accept this position.<br/><br/>It should be noted that this procurement exercise may allow other Health authorities to use any agreements awarded.