Cancer Research UK facility celebrates first GMP batch
pharmafile | July 30, 2010 | News story | Manufacturing and Production | Biotherapeutic, Cancer Research UK, biologics
Cancer Research UK has produced the first batch of product from its recently-completed biologics manufacturing unit, and hopes to release it for clinical testing in the coming weeks.
The £18 million Biotherapeutics Development Unit (BDU) is thought to be unique among medical charities, and dramatically reduces the organisation’s reliance on contract manufacturers, according to CRUK’s Heike Lentfer.
Lentfer, who was appointed to run the facility last October, told Pharmafocus that the unit replaces a much smaller manufacturing unit which could only handle small-scale production of phase I clinical trial materials.
The BDU will allow CRUK to tackle much bigger production projects – handling most phase I and some phase II testing requirements – at a lower cost and in a shorter timeframe.
“[The unit] provides us with the infrastructure to bolster our drug manufacturing capabilities, enabling our scientists to translate their findings from the laboratory into trials of new treatments in the clinic,” said Lentfer.
The first product to be made at the BDU is an antibody called Chi Lob 7/4, designed to boost the immune system of people with cancer. Developed at the University of Southampton, it is currently in phase I testing in patients who no longer respond to conventional cancer treatment.
Based at CRUK’s site in Clare Hall, Hertfordshire, the BDU has 300 sq.m. of Grade C/D cleanroom space, housing 2,50l bioreactors for mammalian cell culture and 70l reactors for microbial production. It also boasts its own aseptic filling suite, allowing CRUK to make finished doses for trials in-house, according to Lentfer. That should reduce the time it takes to get new treatments into the clinic.
“It’s a real boost being able to make the products that our world class scientists need for life-saving research into cancer,” she said. “It is more cost effective and efficient, allowing us to work in a more innovative way to find exciting new treatments to beat cancer.”
The unit can make antibodies, plasmids and recombinant proteins and even has a dedicated suite for making viral products. Staff-wise it has 16 staff in place and another two being recruited.
Capacity depends very much on the mix of work being undertaken, but as a guide the BDU should be able to handle four or five concurrent projects, providing there is a mix of early-stage, pilot and pre-commercial jobs.
CRUK estimates that the BDU will pay for itself if it produces two GMP batches for clinical trials a year, compared to ongoing contract manufacturing costs, said Lentfer. Meanwhile, there is also scope for capacity not taken up by CRUK projects to be offered to third parties.
“We would give priority to non-commercial operations such as academic groups, but would also consider projects from small biotech companies,” she said.
At present the BDU has five live projects – the Chi Lob 7/4 antibody, three development/scale-up biologics – which should move onto GMP batch production stage next year, and one early-stage project.
The unit was designed by eXmoor Pharma, which carried out the original concept study and calculated the required size of the unit, and constructed by Austin. It successfully passed an inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA) at the end of June.
Phil Taylor
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