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Angel to scale up ReNeuron's stem cell lines

By Gregory Roumeliotis, 15-Feb-2006

Related topics: Regulatory & Safety

British biotechnology firm Angel has won a manufacturing contract from stem cell therapeutics expert ReNeuron Group to produce a master cell bank for Huntington's disease, as the company's demand for stem cells increases.

ReNeuron 's lead ReN001 cell line for chronic stroke disability has already been scaled up to good manufacturing practice (GMP) standards with another contract manufacturer in the UK.

 

Under the new contract Angel will manufacture a GMP cell bank for ReNeuron's ReN005 programme which is currently in pre-clinical development and has already generated positive pre-clinical efficacy data.

 

Details of the contract have not been disclosed, but the deal strengthens Angel's relationship with ReNeuron, which started when the companies joined forces in a consortium that was awarded a 3-year grant of £2.2m (€3.2m) by the UK Department of Trade and Industry (DTI) in January 2005.

 

In the bioprocessing project in the consortium, entitled 'Therapeutic Products from Human Stem Cells', Angel is working to establish the capability to manufacture and scale-up stem cell technologies to GMP standards for clinical trials and for their application as therapeutic products.

 

Angel's COO, Gordon Sherriff, told In-Pharmatechnologist.com the new contract was a natural fit for the two companies.

 

"We have a relationship with ReNeuron, we have qualified facilities, we have the skills, so the contract made good sense since we were already working with them.

 

"It's not clear yet how the technology [for ReN005] will scale up but we are looking at a number of options and will we decide on the best one with them."

 

ReNeuron's stem cell platform technology, c-mycERTAM, allows for the efficient creation of hundreds of stem cell lines from an individual tissue sample.

 

The cells are tested for cell characteristics, growth and bankability, as well as their capacity to engraft, with minimal immune rejection by the host, in the relevant disease model.

 

Angel's licenced facility in Edinburgh, specialising in the manufacture of cell based therapies, will be utilised for the contracted GMP manufacturing work.

 

This facility, located at Pentlands Science Park, Edinburgh, was licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in July under the European Clinical Trials Directive.

 

"Angel is an emerging leader in the out-sourced GMP manufacture of cellbased therapies," commented Michael Hunt, ReNeuron's CEO.

 

"Their capabilities play well to one of ReNeuron's key competitive strengths: the ability to generate stable and efficacious stem cell lines which are capable of rapid and early scale-up for the clinic and beyond."

 

In addition to these programmes, ReNeuron is developing stem cell therapies for Parkinson's disease, Type 1 diabetes and diseases of the retina.

 

Huntington's disease is an uncommon, inherited, progressive and fatal neurodegenerative disorder with no available treatments.

 

In the US, approximately 35,000 patients show overt signs of the disease, with a further 75,000 carrying the abnormal gene.