Shilpa Biocare's dedicated recombinant human albumin and fermentation-based manufacturing facility at Kadechur Industrial Area, Yadgir District, Karnataka.
Shilpa Biocare Private Limited, a wholly owned subsidiary of Shilpa Medicare, is developing a dedicated manufacturing facility at Kadechur Industrial Area, Yadgir District, Karnataka, focused on recombinant human albumin and fermentation-based manufacturing.
Corporate disclosures identify the Kadechur site at Plot Nos. 286, 287 and 288, Kadechur Industrial Area, Yadgir, Karnataka – 585221. The project has received Environmental Clearance for establishment of an API, intermediates and recombinant human albumin manufacturing industry.
Shilpa’s recombinant human albumin is developed using a non-human expression system, providing a virus-free production approach and avoiding the limitations associated with human-plasma-derived albumin. The technology is intended as an alternative to conventional plasma-derived albumin for biopharmaceutical manufacturing, cell culture, vaccine formulation, pharmaceutical formulation, regenerative medicine, and cell and gene therapy-related manufacturing.
The key manufacturing proposition: yeast-based expression → fermentation → downstream purification → recombinant human albumin. The major advantage is that the process does not depend on human plasma collection.
Field | Value |
|---|---|
| Total fermentation capacity | 200+ KL |
| Product vessels | 5–50 KL |
| Buffer vessels | 5–15 KL |
Plasma-Derived Albumin | Recombinant Human Albumin |
|---|---|
| Derived from human plasma | Produced through recombinant fermentation |
| Dependent on plasma collection | Scalable through fermentation |
| Donor-pool variability | Controlled and consistent production |
| Human-derived starting material | Non-human production system |
| Plasma-related supply considerations | Scalable manufacturing platform |
| Adventitious-agent concerns associated with human-derived material | Virus-free / non-human production approach |
Cell Culture — a defined albumin source for cell-culture and biopharmaceutical manufacturing processes.
Vaccine Manufacturing — albumin as a stabilizing component in vaccine formulations.
Biopharmaceutical Formulation — supports protein stability and reduces adsorption and aggregation-related challenges in formulation.
Cell & Gene Therapy / Regenerative Medicine — a non-human-source raw material helps manufacturers address animal/human-origin material considerations in advanced-therapy manufacturing.
In May 2025, Shilpa Biocare and Finland-based Orion Corporation entered into an agreement for commercialization of Shilpa's recombinant human albumin in Europe. Under the agreement, Orion has exclusive rights to distribute, market and sell the product in Europe, while Shilpa is eligible for development and regulatory milestone payments. The product remains under development.
The Kadechur project has received Environmental Clearance for the API/intermediate/recombinant human albumin manufacturing project. The facility is being developed to support global regulated-market requirements, with the required quality and regulatory systems being established for international markets.
