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 hav...
Buyer
UNIVERSITY OF EDINBURGH
Value
£900,000
Published
29 Jul 2025
Closes
29 Jul 2025
Procurement details
Source
Pcs
Region
United Kingdom
Procurement method
Not provided
Category
Services
Contract starts
Not provided
Contract ends
Not provided
CPV classifications
85121200
Medical specialist services
Lots
Lot 1 Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval
£900,000
DEFINITIONS FDA is the U.S Food and Drug Administration (FDA); the regulator for new clinical drugs GMP means ‘Good Manufacturing Practice’; U.S.A. IND is an “Investigational New Drug Application”; a request to the FDA to be permitted to administer a new prototype drug on human patients for research purposes Lentiviral vector (LVV) is a type of virus (retrov...
Delivery: UKM75, US
Documents
Unlock document linkBatch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval
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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...
Planned procurement notice · Web page
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