Optibumin® 25 – Recombinant human albumin

Product Description

Optibumin® 25 is a high-purity, recombinant human serum albumin (rHSA) at 25% concentration, designed to replace plasma-derived HSA in cryopreservation, cell therapy, and biomanufacturing applications. As the first recombinant, animal-origin-free 25% HSA solution available in a ready-to-use liquid format, Optibumin 25 eliminates the risks associated with blood-derived albumin, ensuring batch-to-batch consistency, pathogen safety, and regulatory compliance.

Free from stabilizers and preservatives, Optibumin 25 provides a chemically defined, scalable, and sustainable solution for industries requiring superior protein quality in critical workflows.

Advantages

• Superior Purity and Performance
  • Highest purity albumin available – free from stabilizers and preservatives.
  • Low lipid content and high mercaptoalbumin (Cys34 free thiol) – essential for drug formulation, viral vector stabilization, and cryopreservation applications.
  • Lowest product-related high molecular weight impurities – ensuring superior consistency and bioactivity.
• Animal-Origin-Free Assurance
  • 100% chemically defined and animal-origin-free (AOF) – eliminates regulatory risks associated with blood-derived HSA.
  • Manufactured using a non-animal, non-human host system, ensuring purity and reproducibility.
  • Raw materials, manufacturing equipment, and packaging are fully animal-free, aligning with regulatory and ethical standards.
• Manufactured in the United States
  • Produced in a tertiary-level, ISO 9001:2015 certified, animal-origin-free facility in the USA.
  • Complete supply and manufacturing chain is owned and operated by InVitria, ensuring unmatched traceability and quality control.
  • Consistent global supply, free from plasma donation limitations.
• Ready-to-Use Format
  • Supplied as a sterile 25% liquid formulation in 100 mL closed-system friendly bags, eliminating the need for reconstitution.
  • Seamlessly integrates into closed-system biomanufacturing workflows, reducing contamination risks and streamlining processing.
  • Long-term stability and scalability for high-volume manufacturing needs.

Applications

• Cryopreservation & Cell Therapy
  • Enables up to 40% DMSO reduction, improving cell viability and patient safety.
  • Enhances T cell recovery and expansion, maintaining critical CAR-T memory phenotypes (Tscm, Tcm) post-thaw.
  • Provides batch-to-batch consistency, ensuring reproducibility in cell therapy manufacturing.
• Gene Therapy & Vaccine Development
  • Stabilizes viral vectors, supporting AAV, LV, and vaccine production.
  • Prevents aggregation and loss of biological activity during long-term storage.
• Stem Cell Expansion & Regenerative Medicine
  • Supports iPSC, MSC, and ESC culture, providing a chemically defined alternative to serum-derived albumin.
  • Enhances cell growth and differentiation, eliminating concerns about plasma variability.
• Biopharmaceutical Formulations & Drug Conjugation
  • High mercaptoalbumin (Cys34 free thiol) allows for superior small-molecule solubilization and drug conjugation.
  • Ensures greater stability in recombinant protein formulations.
• In Vitro Fertilization (IVF) & Assisted Reproduction
  • Ultra-low lipid content improves embryo culture conditions and developmental outcomes.
  • Eliminates pathogen concerns associated with blood-derived albumin.

Technical Specifications

• Formulation: Sterile, ready-to-use 25% liquid solution
• Packaging: 100 mL closed-system friendly bags
• 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
  • Plasma-free, pathogen-free, and chemically defined
  • Aligned with regulatory expectations for closed-system biomanufacturing

Why Choose Optibumin 25?

Optibumin 25 sets a new standard for high-purity albumin solutions, offering unparalleled consistency, purity, and regulatory compliance compared to plasma-derived HSA. Whether for cryopreservation, cell therapy, vaccine production, or biopharmaceutical manufacturing, Optibumin 25 provides the safest, most scalable, and highest-performing alternative on the market.

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