Building on Novozymes Biopharma’s recombinant human albumin Recombumin, Denmark-based Serendex Pharmaceuticals’ leading drug candidate Molgradex — a Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) — has entered Phase I clinical trials.
Molgradex leverages Novozymes Biopharma’s recombinant human albumin, Recombumin to enable development of a stable drug formulation for novel pulmonary (inhalable) delivery. Recombumin, acting as a stabilizer, prevents unwanted derivatization of the labile therapeutic protein by scavenging against generation of reactive species, thereby helping reduce risk of unwanted immunological responses.
Novozymes’ rAlbumin Human USP-NF* Recombumin is the world’s first and only commercially available, animal-free, recombinant human albumin, approved for use in the manufacture of human therapeutics. Recombumin is an effective and versatile stabilizer particularly suited for use in the formulation of protein and peptide drugs that are not readily stabilized with standard excipients. Through various modes of action, Recombumin protects biological products from degradation, adsorption and aggregation. For example, Recombumin has been shown to reduce particle formation in high-concentration protein formulations as well as stabilize various peptide and protein therapeutics by hindering fibrillation and protein aggregation, respectively.
Read more: http://bronchiectasisnewstoday.com/2015/05/21/inhalable-biological-drug-treating-bronchiectasis-severe-pulmonary-diseases-enters-clinical-trials/