Recombumin®: A Pharmaceutical Excipient In The Stabilization Of Therapeutic Protein Products

By Phuong Tran, Tatyana Mitina, Larissa Chirkova, Phil Morton, Darrell Sleep, Anthony Simula and Geoffrey Francis

Introduction

• Albumin has been used to stabilize APIs safely for many years
• Recombumin® (rAlbumin Human) is the world's first cGMP and animalfree recombinant human albumin.
  • Purity >99%
  • Homogeneous
  • Stable; 5yr @ 2-8°C
  • Batch-to-batch consistency
• Current applications:
  • Manufacture of approved vaccines (FDA and EMEA)
  • Drug-conjugation partner for short-lived peptides; successfully completed clinical phase II