Pepceuticals wins approval to manufacture APIs

Published: 1-Sep-2011

UK MHRA gives green light to Leicestershire firm

Synthetic peptide manufacturer Pepceuticals has been given UK MHRA approval to manufacture APIs following a £2m investment in new premises and modern manufacturing facilities in Leicestershire.

Pepceuticals says it is now the largest peptide cGMP manufacturer in mainland UK and the Research Council UK’s (RCUK) preferred supplier of peptides and antibodies.

The 10,000ft2 (929m2) industrial unit has been equipped with eight cGMP laboratories, enabling Pepceuticals to support research and in-process projects from pre-clinical toxicology studies through to early stage clinical trials, and eventually to full manufacturing of approved APIs for larger clinical trials.

Managing director Kamal Badiani, who founded the company 13 years ago, said: ‘The peptide industry is booming and we have been achieving 20% year-on-year growth for the past two years. We now have the capacity and capability to deliver a complete chemistry manufacturing solution to the pharmaceutical industry.’

Pepceuticals has appointed Daniel Milek as a new head of sales to open up opportunities with universities, pharmaceutical manufacturers and research bodies. Milek was previously a project leader at Thermo Fisher Scientific in Loughborough.

Pepceuticals’ facilities in Enderby, Leicestershire have recently seen the installation of a Quatro Premier Xe mass spectrometer, a Synapt G1 high definition mass spectrometer, 2 Symphony 12-channel peptide synthesisers and an Overture robotic peptide library synthesiser.

The company has also applied to the MHRA for a specials licence, allowing it to manufacture unlicensed products for use in early studies and clinical trials, and is awaiting a decision.

Pepceuticals has a five-year contract worth £400,000–£500,000 a year with the Research Councils of the UK, which encompasses organisations including the Medical Research Council, and the Biotechnology and Biological Sciences Research Council.

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