Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing.

Unlabelled: We report on the stability assessment of a recombinant human epidermal growth factor (rhEGF) freeze-dried formulation for wound healing by intra-lesional injections. The suitability of packaging material for the light protection of finished dried powder was evaluated after stressed exposure conditions. Degradation kinetics of powder for injection was investigated at concentrations of 25-250 μg/vial and temperatures of 45, 60, and 70 °C.

Procurement of reference materials against recombinant HBsAg surface antigen.

Mabs against HBsAg have been used for structural analyses, development of diagnostic tests, and for antigen immunopurification. Resultant products obtained from current methods of genetic recombination demand reference materials to test their potency, identity, purity, and the biological and immunological specific activity corresponding to their manufacturing processes. In this paper, we present a method for the qualitative and quantitative characterisation of CB.