Exbumin^® – Recombinant human albumin excipient

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.

See the Terms page for more information about the trademarks and patents covering this product.