Exbumin® – Recombinant human albumin excipient

Product Description

Exbumin® is a high-purity recombinant human serum albumin (rHSA) approved as an excipient in injectable human vaccines by the FDA, EMA, and PMDA. Produced using InVitria's animal-free ExpressTec expression platform at an ISO 9001:2015-certified, cGMP-compliant facility in Junction City, Kansas, Exbumin is a fully defined, blood-free, animal-origin-free alternative to plasma-derived human serum albumin.

Exbumin is a formulation component in Merck's ERVEBO® Ebola vaccine — the first licensed injectable human vaccine to incorporate recombinant albumin as an excipient — and has been administered in hundreds of millions of doses worldwide since ERVEBO's FDA, EMA, and PMDA approvals in 2019.

With ≥98.0% purity, endotoxin levels ≤0.02 EU/mg, and no added preservatives or stabilizers, Exbumin supports viral vector stabilization, vaccine formulation, cryopreservation, cell therapy manufacturing, and regenerative medicine applications requiring a defined, traceable, injectable-grade protein. Exbumin is available with full regulatory documentation — Certificate of Analysis, Safety Data Sheet, Animal-Free Statement, TSE/BSE Statement, ISO 9001 certificate, cGMP Statement, and regulatory-supporting packages — to accelerate IND, BLA, and supplier qualification workflows.

Advantages

Regulatory Precedent and Compliance

• Approved as an injectable excipient by the FDA, EMA, and PMDA — the recombinant albumin excipient in Merck's ERVEBO Ebola vaccine (approved 2019)
• Tested with consideration to the USP-NF monograph for recombinant human serum albumin
• Manufactured under a cGMP-compliant Quality Management System aligned with 21 CFR Part 210/211 at an ISO 9001:2015-certified US facility
• Full regulatory documentation available: Certificate of Analysis, Safety Data Sheet, Certificate of Origin / Animal-Free Statement, ISO 9001 certificate, cGMP Statement, and IND-supporting packages

Purity and Defined Composition

• ≥98.0% purity
• Endotoxin level ≤0.02 EU/mg
• No added preservatives or stabilizers — unlike most plasma-derived albumin
• 100% animal-origin-free and blood-free — eliminates risks of adventitious viral, prion, and bacterial pathogens associated with plasma sourcing

Supply Chain Reliability

• End-to-end vertically integrated US-based manufacturing
• Consistent lot-to-lot performance enabled by recombinant expression, not donor-dependent sourcing
• Scalable to metric-ton production volumes without supply constraints from blood donation or fetal bovine serum availability
• 4-year shelf life when stored at –20°C

Performance in Biomanufacturing

• Demonstrated improvement in viral vector stability for vaccine and gene therapy formulations (documented in peer-reviewed Virus Research, 2023)
• Maintains cell and tissue viability during cryopreservation, including in reduced-DMSO T-cell protocols
• Preserves protein activity and formulation integrity over extended storage

Applications

Vaccine Formulation and Stabilization Exbumin is used as an injectable excipient in licensed human vaccines, including Merck's ERVEBO Ebola vaccine. It improves the thermal stability, shelf life, and cold-chain performance of live-attenuated, recombinant vector, and subunit vaccine formulations. Typical use concentration: 0.1–2% w/v as a stabilizing excipient.

Gene Therapy and Viral Vector Manufacturing Exbumin enhances the stability of AAV, lentiviral, and recombinant viral vectors during formulation, downstream processing, and storage. Published data demonstrate improved downstream virus purification yields using Exbumin as a process additive (Cytotherapy, 2023). Compatible with serum-free and chemically defined biomanufacturing workflows.

Cell Therapy Manufacturing and Cryopreservation Exbumin supports T-cell, stem cell, and other advanced therapy manufacturing workflows, including CAR-T expansion and cryopreservation media. Demonstrated performance in reduced-DMSO cryopreservation protocols for T cells, preserving post-thaw viability and functional recovery.

Biologics Formulation and Drug Stabilization Exbumin stabilizes therapeutic proteins, monoclonal antibodies, and antibody-drug conjugates by reducing aggregation, preventing surface adsorption, and maintaining protein activity in lyophilized and liquid formulations. Used as an excipient in injectable drug products requiring a defined, non-blood-sourced stabilizer.

Regenerative Medicine and Tissue Preservation Exbumin supports ex vivo tissue storage and organ preservation protocols, protecting cell membranes from oxidative stress and maintaining functional integrity prior to implantation or clinical use.

LNP and Liposome Therapeutics Exbumin is used to optimize the performance of lipid nanoparticle and liposome-based therapeutics, supporting formulation stability and in vivo performance (see InVitria white paper  - Optimizing the Performance of LNP and Liposome Therapeutics with Blood-Free Recombinant Albumin).

Exbumin Frequently Asked Questions (FAQs)

Product Overview 

What Is Exbumin and What Is It Used For in Biopharmaceutical Manufacturing?

Exbumin is an excipient-grade recombinant human serum albumin supplied as a lyophilized powder for biopharmaceutical and advanced therapy applications. It is produced using a non-mammalian expression system with no blood-derived inputs, providing a defined, traceable albumin source for drug formulation, stabilization, and downstream processing.

Why Use Recombinant Albumin Instead of Plasma-Derived Albumin for Drug Formulation?

Plasma-derived albumin introduces adventitious agent risk, donor variability, and increasing regulatory scrutiny around blood-derived excipients. Exbumin eliminates these risks with a fully defined, non-blood-sourced protein that delivers comparable stabilization functionality with a cleaner, more consistent profile.

Regulatory and Quality

Is Exbumin Suitable for Use in Injectable Drug Products?

Yes. Exbumin meets excipient-grade specifications making it appropriate for evaluation in injectable formulations. cGMP manufacturing and ISO 9001:2015 certification support the documentation and quality requirements for IND/BLA-stage and commercial pharmaceutical programs.

Has Recombinant Albumin Been Approved as an Excipient in an Injectable Vaccine?

Yes. Exbumin is the recombinant albumin excipient used in Merck's ERVEBO Ebola vaccine, which received FDA, EMA, and PMDA approval in 2019. It was the first recombinant human serum albumin approved as an excipient in an injectable human vaccine and has been used across hundreds of millions of doses.

Does InVitria Provide a Drug Master File (DMF) or Equivalent Regulatory Documentation for Exbumin?

InVitria provides a product-specific Technical Summary for Optibumin 25 containing CMC-style documentation — including manufacturing process, raw material controls, characterization data, release specifications, and lot analysis — designed to support customer regulatory submissions globally, including IND, BLA, and comparable filings under FDA, EMA, and other regulatory authorities. Unlike a Drug Master File, the Technical Summary is provided directly to the customer for incorporation into their own regulatory documentation, giving customers full visibility into the CMC information and supporting global filings without being tied to a single regulatory pathway. The Exbumin Technical Summary is supported by per-lot Certificates of Analysis, Animal-Origin-Free / TSE-BSE statements, ISO 9001 certification, cGMP statements, and change notification under defined policies. Contact us to request the Technical Summary.

Is Exbumin USP Grade?

Exbumin specifications are tested with consideration to the USP monograph for recombinant albumin (USP "rAlbumin Human"). Its excipient-grade release specifications are aligned with the expectations of the USP monograph and the regulatory standards applied to injectable biologics.

As an FDA-, EMA-, and PMDA-approved excipient with precedent in a licensed injectable human vaccine (Merck's ERVEBO), Exbumin has been evaluated against the quality attributes relevant to compendial recombinant albumin specifications. Contact InVitria for full regulatory and compendial documentation.

Is Exbumin cGMP-Manufactured and Animal-Origin-Free?

Yes. InVitria manufactures Exbumin under cGMP-compliant Quality Management System (QMS) with respect to 21 CFR Part 210/211 at its ISO9001:2015 certified facility in Junction City, Kansas, USA.

What Are the Purity and Endotoxin Specifications for Exbumin?

Exbumin is supplied as a lyophilized powder with purity ≥98.0%, endotoxin ≤0.02 EU/mg, and pH 6.50–7.50 upon reconstitution.

What Quality Documentation Is Available for Exbumin?

Exbumin is supported by a CoA, SDS, Guidelines for Use, Certificate of Origin and Animal-Free / TSE-BSE Statement, ISO9001 certificate, and cGMP Statement. Additional Quality and Regulatory documentation is available on request — including materials for IND-supporting packages and supplier qualification.

Selection and Comparison 

What Is the Difference Between Exbumin and Cellastim® S?

Exbumin is the excipient-grade albumin designed for biopharmaceutical formulation, drug stabilization, and injectable applications. Cellastim S is the cell culture-grade albumin designed for serum-free media supplementation, with specifications appropriate for that application.

If you are formulating a drug product or stabilizing a therapeutic, Exbumin is the correct product. If you are supplementing cell culture media, Cellastim S is appropriate.

What Is the Difference Between Exbumin and Optibumin®?

Application and Use

Can Exbumin Be Used to Stabilize Viral Vectors or Vaccines?

Yes. InVitria's application note titled Exbumin – Stabilizing Virus with Albumin to Improve Yield shows Exbumin improving viral stability in vaccine and gene therapy contexts by providing a defined stabilizing protein environment. Inclusion level and compatibility are validated during formulation development based on the specific virus and target product.

What Is the Reconstitution Protocol for Exbumin?

InVitria's Exbumin reconstitution application note  as well at the reconstitution video provides a reproducible protocol to prepare a sterile 10-20% stock solution using gentle mixing and sterile filtration. This supports consistent, aseptic preparation for in vitro workflows and formulation use.

Packaging and Ordering

What Packaging Options Are Available for Exbumin?

Exbumin is available as a lyophilized powder in 10 g and 100 g formats. Contact InVitria for bulk and custom packaging options to support clinical and commercial biopharmaceutical manufacturing.

How Can I Order Exbumin?

Exbumin is available worldwide through multiple purchasing pathways. Most customers work directly with InVitria for full access to the Exbumin product portfolio, bulk and commercial-scale supply, favorable volume-tier pricing, faster supply chain turnaround, GMP supply commitments, and regulatory documentation support. Exbumin is also available through Fisher Scientific, VWR, and the Labviva procurement platform (which integrates with Ariba, Coupa, Oracle, and Jaggaer) for customers whose institutional procurement systems require integrated supplier ordering. European customers can order with direct fulfillment from InVitria's Rotterdam, Netherlands facility. All customers receive the same product, Certificate of Analysis, and technical support regardless of channel. Contact InVitria or request bulk pricing to place an order.

Storage and Handling

How Should Exbumin Be Stored?

Store lyophilized Exbumin at –20°C, protected from light. Follow the Guidelines for Use for aseptic reconstitution and sterile filtration prior to use in sterile workflows. Shelf life is 4 years from date of manufacture.

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