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

What this is

The University of Edinburgh seeks a supplier to batch manufacture high-titre, GMP-compliant (FDA) lentiviral vector for FDA approval, supporting a phase I/II clinical trial for a rare genetic disease. The supplier must have proven experience producing regulatory-approved LVVs; the three-year agreement covers an initial 30L harvest delivery plus optional further deliveries.

Key points

• GMP lentiviral vector batch manufacture
• FDA-compliant for a phase I/II trial
• Estimated value GBP 900,000

Who can bid

Supplier must have extensive prior experience manufacturing GMP lentiviral vectors that achieved regulatory approval for phase I/II clinical trials.

Money

Budget appetite around USD 560k for the initial delivery; three-year agreement.

Classification

CPV 85121200 — Medical specialist services Scotland