NBC helps Onyvax out in cGMP contract with Eden
Biomanufacturing Centre (NBC), biotech firm Onyvax has hired
contract manufacturer organisation (CMO) Eden Biodesign to supply
it with clinical current good manufacturing practice (cGMP)
services for its cell vaccine programme in ovarian cancer, in the
first contract at the site to have received public funding.
Not only will Onyvax have access to the NBC's £34m biomanufacturing facilities in Liverpool, but it will also be entitled to Eden's consultancy services, including strategic development guidance and international regulatory affairs advice.
However, money from the governmental fund is only available to small British companies and academic groups which have a good product idea but need assistance in purchasing services from the NBC; SR Pharma, a European biopharmaceutical company specialising in RNAi therapeutics, got no public funding for its contract with Eden in December.
Still, the centre is available to any biotech company that can afford the initial manufacture of biopharmaceuticals, which could then be used in early trials.
"If you consider that nine out of ten drugs fail in clinical trials, you appreciate that developing a new drug is a risky business," Derek Ellison, Eden's director of business development, told In-PharmaTechnologist.com.
"There are some great projects out there, particularly in the academic world, which need funding and the NBC offers them an opportunity to realise their potential."
The NBC spans approximately 4,100 square metres and comprises three GMP pilot plants, catering for mammalian, microbial and live virus products, three process development suites with dedicated upstream and downstream areas, an extensive analytical laboratory area, office accommodation and a central services and facilities area.
Its quality control and analytical development laboratories are capable of performing most techniques required for biopharmaceutical batch release and in-process testing.
"The NBC has an excellent set of factories and we are delighted to have access to these facilities," Onyvax's CEO Anthony Walker told In-PharmaTechnologist.com.
"Eden is a quality GMP manufacturer and we are confident our collaboration with them will lead to the quick and successful development of our ovarian cancer vaccine."
Onyvax's ovarian cancer vaccine is based on the same technology as Onyvax-P, the company's lead product for prostate cancer that has generated encouraging results in Phase IIa clinical trials.
The company has asked Berna Biotech in Switzerland to make batches of the prostate cancer vaccine for use in Phase II/III trials.
Each of Onyvax's vaccines consists of a combination of multiple cell-lines that represent different stages of the particular cancer.
Because there is only one vaccine formulation for each cancer type, these vaccines can be manufactured in bulk under optimised conditions.
During the manufacturing process the cells are inactivated so they cannot reproduce in the human body.
The company said it is hoping to roll out the technology to a range of other cancers over the next few years and start clinical trials in ovarian cancer in 2007/2008.
More information and an application form for the NBC access fund is available online >here.
