PRESS RELEASE...

SMALL-SCALE BIOMANUFACTURING ‘ALIVE AND WELL’,

NOW TO UNLOCK THE POTENTIAL

Leading figures from the field of cell and gene therapy gathered at Bristol Zoo Gardens to address issues surrounding the development of pioneering patient treatments through small-scale bio-manufacturing.

There was particular emphasis on the regulatory regime and the need to develop Good Manufacturing Practice in small-scale biomanufacturing facilities, but without stifling innovation.

The conference was organised by BioApproaches South West, the representative body for the bio-technology sector in the region, and sponsored by the national bioProcessUK Knowledge Transfer Network.

Gill Lewis, of Cancer Research UK, which is developing its own bio-therapeutic facilities and has the nation’s third largest product pipeline in cell and gene therapy behind GSK and Astra-Zeneca, was in no doubt about the event’s value in showcasing clinical pharma-manufacturing.

“It showed that this branch of bio-manufacturing sector is very much alive and well,” said Gill, one of the keynote speakers.

“At Cancer Research, we have a proven track record in early drug development and clinical trials. The charity is committed to ensuring that patients continue to benefit from the latest research into cancer treatments.  People have been very interested in how we have tackled the issues of design and validation of a multi product bio-manufacturing facility.

“In particular, this event has allowed us to tackle regulatory issues – the regulatory environment is a huge obstacle. We need more help in that area, particularly in how the regulations are applied and how the costs for academia are being increased under the guise of regulation.”

Ian Rees, of the Medicines and Healthcare products Regulatory Agency, one of the speakers, was on hand to respond on behalf of the regulators, explaining afterwards: “We do want to engage with industry – especially those parts that are new and developing – and to make sure that in conjunction with the UK’s Better Regulation agenda that medicines regulation is proportionate and that there are no unintended consequences from the introduction of new legislation.

“Much of medicines regulation comes from Europe, so when implementing new legislation, such as the Advanced Therapy Regulation, we have to ensure that we set the bar high

enough to prevent unsafe products onto the market but not so high that there are no products at all.  We have to strike a pragmatic balance.

Of course, our regulations are not the only ones that industry has to deal with – there are also those relating to Health & Safety, genetically modified organisms. Tthe Better Regulation agenda is intended to minimise that burden.”

Olivier Danos, Director of the Gene Therapy Consortium at University College London, was able to provide an academic perspective.

“These are fast-evolving technologies but they need to be anchored in academia. Yet there is a paradox – people in academia running GMP bio-manufacturing facilities need the disciplines of industry, but these are not easily found in an academic environment.

“Academics are very often isolated from hard core bioprocess and regulation. They can come up with great projects but which get delayed because they cannot make the right connections. The technology is a moving target in that you can start with a given bioproduct but find out at the end that it’s not the most suitable one – so you need a working process.

“This kind of gathering does very well, however, in getting people together to share views. The regulators want to listen to us too. It’s very much a proactive process.”

The event was attended by over 90 delegates from across the UK, representing all aspects of the bio-pharma industry. Mark Bustard, Technical Manager at bioProcessUK, was delighted to be involved in the meeting which gave prominence to this specialist group of UK manufacturers. 

Pauline Lee, manager of BioApproaches South West, said: “Although there are a number of issues surrounding the development of small-scale GMP biomanufacturing facilities, there is a collective will to unlock the potential of research in cell and gene therapies.

“Bringing like-minded people together in this way will, I am sure, speed this process.”

ENDS

Notes to editors:

BioApproaches South West is a biotechnology and life sciences support group for the South West of England, a programme funded by the South West of England Regional Development Agency (SWRDA) and currently managed by GWEBusinessWest.

It provides targeted activities in response to the emerging biotech sector’s needs.

BioApproaches South West supports the biotechnology and life sciences sectors in the region by:

• Facilitating knowledge transfer and disseminating best practice
• Promoting the strengths and successes of the sector
• Helping companies source expertise and information and network
• Actively supporting business collaborations in the sector
• Promoting new market opportunities within the region and beyond.
• Hosting and collaborating on  sector-specific seminars and other events (both regional and national)
• Sponsoring sector -focused regional events
• Promoting the region’s businesses and research institutes both nationally and internationally

ENDS