Procurement

Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval

Procurement identifier (OCID): ocds-h6vhtk-0568ca

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 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.