Cobra Biologics to Scale Production of Growth Hormone

November 23, 2015
Pharmaceutical Technology Editors
PTSM: Pharmaceutical Technology Sourcing and Management
Volume 11, Issue 12

The University of Sheffield has appointed Cobra Biologics to advance novel fusion protein technology into Phase 1 clinical trials.

Cobra Biologics has been appointed by the University of Sheffield, UK, to provide manufacturing service for a potential growth hormone (GH) antagonist created using ProFuse Technology originally developed by the University of Sheffield. This work will allow Sheffield University to progress toxicology trials and prepare for Phase 1 clinical trials, with the help of the Medical Research Council (MRC): Developmental Pathway Funding Scheme (DPFS) provided by the UK Biomedical Catalyst.

ProFuse Technology is a fusion technology in which hormones are fused to the extracellular domain of their receptors. The resulting fusion protein has a longer circulation half-life than the native hormone as it is larger in size, and is able to compete with the natural hormone for receptor binding.

Cobra will be using its cell line development service, maxXpress, to produce the GH antagonist fusion protein. By disrupting GH binding and thus preventing the cellular changes normally initiated by the hormone, it is hoped that the protein will be successful in the treatment of patients suffering from Acromegaly, a condition of excessive body growth due to GH over-production. This condition results in increased morbidity and mortality, as reported in a Nov. 23, 2015 press statement.

As part of the service, Cobra will be providing scale-up and non-GMP manufacture at 250 L, formulation development, and fill-finish.

Source: Cobra Biologics