The Cancer Research UK Biotherapeutics Development Unit (BDU) was constructed in 2010 at South Mimms near Potters Bar. It is a modern, MHRA licensed, fully cGMP-compliant, 2000 sq metre facility that is engaged in the process development and GMP production of novel Investigational Medicinal Products (IMPs) for phase I clinical trials sponsored by Cancer Research UK.

Recent Challenges

Recent challenges at the BDU included the introduction of an automated filling and stoppering procedure, which was previously performed manually using a dosing pump. This method was very "hands-on" and labour intensive which resulted in a slow process throughput.

This manual procedure was unsatisfactory for such a leading edge facility and a reliable automated vial filling process was required for the delivery of future BDU projects.

Best practice solution

"We wanted a vial filling and stoppering process more in step with our modern facility," explains Tim Hillyer, Senior Scientific Officer at the BDU. "To help deliver this we set out to source a machine capable of rapid, repeatable filling but without any compromise to process quality and control."

The answer arrived in the shape of a Flexicon FP50 tabletop filling and stoppering machine from Flexicon Liquid Filling, part of the Watson-Marlow Pumps Group. Capable of filling up to 25 vials a minute (up to 100ml capacity) the system also offers quick and easy change-over between batches.

"As a multi-product facility producing small batch size, high-value IMPs the flexibility offered by the FP50 was ideal for our purposes," says Mr Hillyer. "Our most recent batches involved not more than a few litres in quantity so having a reliable method for product filling and stoppering enables us to bring new drugs into the clinic in a controlled and reproducible manner."