Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval
What the buyer wrote
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…
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Details
- What the buyer calls it
- Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval
- How they are buying
- Advertised, then negotiatedThe buyer talked terms with bidders rather than taking fixed offers.
- Type
- goods
- Where
- in Scotland
- Kind of work
- Clinical and healthcare services, Pharmacy and medicines
Who the buyer named
Suzanne Toole was the named contact on this notice.