Tender Details

Country: United Kingdom
Summary: Batch Manufacture of High Titer/Titre Gmp (U.S.A.) Compliant Lentiviral Vector for Fda Approval
GBT Ref No: 123612480
Deadline: 01 Sep 2025
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: GBP 900000.00
Notice Type: Tender
Document Ref. No.: JUL535766
Purchaser's Detail:
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Description:
Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval
We are planning a phase I/II clinical trial to treat a rare genetic disease that causes progressive dementia in children. Our therapy will use autologous CD34+ haematopoietic stem progenitor cells (HSPCs) which are modified ex vivo with LVV to express supraphysiologic levels of a secreted enzyme.In order to progress this therapy, we require a high titre LVV produced to good manufacturing practice (GMP) standard. The supplier must have extensive previous experience manufacturing LVVs to this specification which have achieved regulatory approval for phase I/II clinical trials, ideally for use in human CD34+ HSPC transduction.The QC defined must be performed in compliance with FDA regulations. The product of the initial delivery will be delivered directly to the University of California, LA, USA.Note that throughout the document the British spelling ‘Titre- has been used; this is analogous to the American English term ‘Titer- and the spellings may be used interchangeably.The University anticipates initially awarding for;- Manufacture of concentrated lentiviral vector (LVV) from a 30L viral harvest- Such award to include any warranties on quality, product replacement (for spoilage), transport, and other supplier project costs such as (but not limited to) quality control testing and audit.The cost estimate of the procurement reflects the anticipated cost of the initial requirement p...
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Batch Manufacture of High Titer/Titre Gmp (U.S.A.) Compliant Lentiviral Vector for Fda Approval - Unitedkingdom Tender

The UNIVERSITY OF EDINBURGH, a Government sector organization in United Kingdom, has announced a new tender for Batch Manufacture of High Titer/Titre Gmp (U.S.A.) Compliant Lentiviral Vector for Fda Approval. This tender is published on UnitedkingdomTenders under GBT Ref No: 123612480 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-09-01.

The estimated tender value is GBP 900000.00, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.