Product Description
Exbumin® is a high-purity recombinant human serum albumin (rHSA) designed to enhance stability, biocompatibility, and performance across biopharmaceutical and cell therapy applications. Manufactured under ISO 9001:2015-certified, cGMP-compliant conditions in the United States, Exbumin is a chemically defined, blood-free, and animal-origin-free alternative to plasma-derived HSA.
As one of the few excipients approved for injectable therapeutics, Exbumin has been used in hundreds of thousands of clinical injections worldwide. Its exceptional stability, ultra-low endotoxin levels, and biocompatibility make it ideal for applications such as vaccine and gene therapy formulation, cryopreservation, regenerative medicine, and cell therapy manufacturing.
Advantages
- Regulatory & Manufacturing Excellence
- Approved as an excipient for injectable therapeutics by regulatory agencies.
- Manufactured in the United States in an ISO 9001:2015-certified, cGMP-compliant facility.
- Complete end-to-end supply chain control, ensuring batch-to-batch consistency and secure availability.
- Purity & Performance
- 100% blood-free, chemically defined, and animal-origin-free – eliminating risks associated with plasma-derived albumin.
- Ultra-low endotoxin levels – ensuring safety and stability for biopharmaceutical and cryopreservation applications.
- Controlled sodium specification – enabling precise sodium content management for final formulations.
- Stability & Versatility
- Proven to improve viral stability in vaccine and gene therapy formulations.
- Enhances cell and tissue viability for cryopreservation, regenerative medicine, and cell therapy applications.
- Maintains protein activity and formulation integrity over extended storage periods.
Applications
- Vaccine & Gene Therapy Formulation
- Enhances stability and shelf-life of viral vectors such as AAV and LV in gene therapy applications.
- Approved excipient for injectable biologics, supporting regulatory compliance.
- Cryopreservation & Cell Therapy
- Maintains tissue and cell viability during long-term cryopreservation and storage.
- Used in cell therapy and regenerative medicine to protect cells from stress-induced damage.
- Biopharmaceutical Manufacturing
- Provides a stable protein environment for sensitive recombinant protein formulations.
- Used in antibody-drug conjugation to enhance solubility and bioavailability.
- Regenerative Medicine & Tissue Storage
- Supports ex vivo tissue preservation, ensuring functional integrity before implantation.
- Protects cell membranes from oxidative stress, enhancing therapeutic efficacy.
Technical Specifications
- Formulation: Sterile, ready-to-use recombinant albumin
- Manufacturing: Produced in a state-of-the-art, ISO 9001:2015-certified facility in the USA
- Quality Assurance:
- Fully recombinant and animal-origin-free production system
- Stringent quality control processes ensure high batch-to-batch consistency
- Regulatory Compliance & Safety:
- cGMP-compliant manufacturing
- Approved as an excipient for injectable therapeutics
- Aligned with regulatory expectations for biopharmaceutical and cryopreservation applications
Why Choose Exbumin?
Exbumin is a recombinant, chemically defined alternative to plasma-derived albumin, offering unparalleled purity, stability, and regulatory compliance. Whether used in vaccine and gene therapy formulation, cryopreservation, or regenerative medicine, Exbumin provides a safe, scalable, and high-performance solution for biopharmaceutical manufacturers and researchers.