Partner
A number of companies with an approved human growth hormone (hGH) on the market are seeking to develop higher dose presentations in order to differentiate the highly competitive market. Majority of the existing formulations cannot support concentration to levels desired.
Problem
At concentrations of hGH above 5 mg/ml the levels of aggregates present is usually greater than 4%, a level acceptable to the European Pharmacopeia. Furthermore, as the storage temperature is raised above 2-8ºC the formation of high molecular weight species (HMWS) as measured by size-exclusion HPLC, increases significantly.
Strategy
Arecor has observed this problem with aqueous formulations of several therapeutic proteins. It is therefore in a position to resolve the problem quickly through the application of Arestat-T™ buffers and excipients.
Results
• A formulation of hGH containing a concentration greater than 5 mg/ml was developed using Arecor’s displacement buffers with a significantly improved the stability profile compared to some existing formulations based upon Phosphate or Histidine.
• Arestat-T formulation of high dose hGH, based upon the Arecor’s displacement buffers demonstrated less than < 0.5% HMWS after 4 weeks of storage at 40ºC.
• The formulation developed creates an opportunity for delivery of hGH via multi-dose pen which after the first use could be stored at 40ºC for 1 week.