Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval
Buyer: University Of Edinburgh
- Published
- 29 July 2025
- Estimated value
- £900,000
- Place of performance
- UKM75
- Lots
- 1
- Notice number
- 043991-2025
- Reference
- ocds-h6vhtk-056864
- Official source
- Official source
Description
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 spoila…
Official publications
- FTS · 043991-2025 · 29 July 2025
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Frequently asked questions
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- The estimated value published by the buyer is £900,000.
- Who is the buyer of this tender?
- The contracting authority is University Of Edinburgh (United Kingdom).
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