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 plus contingency, for (for example but not limited to), 1. Scope extension, 2.

Additional ad-hoc delivery to support further trials.

The time frame of the agreement – 3 years, reflects an initial delivery period expected to be no longer than 12 months post signature, and the option to buy additional deliveries for two years thereafter. The University may award additional deliveries to the awarded supplier via the Negotiated Procedure Without Prior Call for Competition.

For transparency we have a budget appetite of approximately USD560k for the delivery of the initial services. We may review this estimate from time to time.

Having posted this notice we reserve the right to repost any subsequent notice (including if the ultimate procurement procedure is re-run) under reduced timescales as set out in the regulations.