Human serum albumin has long been used in pharmaceutical manufacturing and as a therapeutic protein. Traditionally, albumin has been obtained through fractionation of donated human plasma. Recombinant human albumin provides an alternative manufacturing approach based on recombinant expression and fermentation.
A recombinant platform can offer controlled manufacturing, defined raw-material provenance, consistent production, scalable fermentation, reduced dependence on plasma supply and a non-human production system. Shilpa's FY2024–25 Annual Report states that its recombinant human albumin was developed through a patented, environmentally friendly process, with an emphasis on consistent quality, scalability and cost competitiveness. The company also reported filing its first US FDA Drug Master File for 20% recombinant human albumin.
Shilpa Biocare's Kadechur facility is reported to have more than 200 KL per annum fermentation capacity, with product vessels ranging from 5 KL to 50 KL and buffer vessels from 5 KL to 15 KL.
Recombinant albumin has potential applications in biopharmaceutical manufacturing, cell culture, vaccine manufacturing, pharmaceutical formulation, advanced therapy manufacturing and other therapeutic applications.
The development of recombinant human albumin represents a shift toward scalable, controlled and non-plasma-based manufacturing. For biopharmaceutical manufacturers, this can provide an additional option for managing raw-material provenance and supply requirements.
