Excipients for Final Formulation

Excipients for Final Formulation of Vaccines, Cell Therapies, Gene Therapies, and Biologic Therapies

Maintenance of stability and potency from manufacturing to patient delivery is a critical aspect of development for biologics, cell therapies, vaccines, and gene therapies. These medicines are highly susceptible to degradation and loss of potency during storage, transportation, and delivery. Formulating a stable product requires excipients to preserve therapeutic viability, but there are few approved excipients available for these applications. Because excipients are eventually administered to the patient in conjunction with the therapeutic ingredients, they must pass rigorous regulatory and safety standards for the clinical route of delivery.

Exbumin® is the only excipient-grade recombinant human serum albumin approved for use in final formulation. It is manufactured in an animal-free host and has been approved for use in the final formulation of injectable biologics by both the FDA and the EMA. As an example, Exbumin is included as a final formulation component of the first FDA and EMA approved Ebola vaccine – ERVEBO produced by Merck. As a vaccine final formulation component, Exbumin has demonstrated safety in over 250,000 human injections.  Exbumin can be used not only in the final formulation of a viral vaccine, but can also be supplemented into virus-producing cultures to increase virus titer without the addition of any animal-derived components.

Inclusion rates for Exbumin are specific to the application. InVitria’s product specialists are available to provide expert advice regarding inclusion rates and optimization of Exbumin in your application.

Optibumin® is the highest purity albumin on the market with high mercaptoalbumin and low aggregate content. It is ideally suited for hydrophobic molecule solubilization, small molecule stabilization and for surgical adhesives. It can also be used in diagnostics to stabilize samples and as a component in diluents. Optibumin is supplied as a 10% solution.

To learn more about specific applications of Optibumin, please contact InVitria Product Applications Team.

InVitria’s recombinant human serum albumin products designed for final formulation usage are:

  • cGMP grade
  • Fully recombinant
  • Fully human in sequence
  • Expressed in a non-animal host
  • Free of animal-derived contaminants and adventitious pathogens
  • Free of IgG
  • Eliminates concerns about donor-to-donor variability
  • Manufactured, processed, and packaged in the USA

InVitria’s animal-free rHSA products are suitable for:

  • Stabilization of cell therapies during cryopreservation
  • Stabilization of RNA viruses for vaccines and therapies
  • Stabilization of DNA viruses for vaccines and therapies
  • Stabilization of therapeutic proteins
  • Stabilization of therapeutic antibodies
  • Solubilization of hydrophobic molecules
  • Cryopreservation of cells and tissues for cell therapies, regenerative medicine, and IVF
  • Other clinical applications of albumin

Related Resources

Resource Type Title Cell Lines Relevance
Application Note High-Resolution Analytical Characterization of Optibumin®: Structural Homogeneity and Functional Consistency Compared to Plasma-Derived HAS — <0.5% aggregates, 99% reduced Cys34, 3x higher binding affinity vs plasma HSA — supports drug conjugation.
Application Note A Binding Advantage: Optibumin® Demonstrates Enhanced Drug Binding and Consistency over Plasma Albumin — Optibumin 25 demonstrates ~3x higher warfarin binding affinity vs plasma HSA — supports drug conjugation precision.
Application Note rHSA Reconstitution Video Protocol — Video walkthrough of rHSA reconstitution.
Application Note Thiol by Combat: Enhanced Covalent Conjugation with Recombinant Albumin Compared to Human Plasma-Derived Albumin — Optibumin 25 is 99% mercapto-albumin (free Cys34 thiol) vs ~60% in plasma HSA — 3x higher conjugation efficiency.
Application Note Exbumin – Reconstitution Application Note — Reconstitution protocol for Exbumin as a final formulation excipient.
White Paper Optimizing the Performance of LNP and Liposome Therapeutics with Blood-Free Recombinant Albumin — Literature review on rHSA in LNP and liposome therapeutic formulations.
White Paper Emergence of Blood-Free Recombinant Human Albumin — Foundational rHSA white paper covering final formulation applications.
Poster Advancing Vaccine Excellence VERO Excipient role of recombinant proteins in vaccine cold-chain stability.
Poster Addressing Vaccine Stability And Cold Chain Challenges With Recombinant Human Serum Albumin To Enable Global Administration — rHSA as an excipient for vaccine cold-chain stability — relevant for live attenuated and viral vector formulations.
Poster Virus Yield Improvement for Downstream Processing: Exbumin®, Excipient Recombinant Albumin — Exbumin as excipient and stabilizer in viral final formulation.
Case Study How Merck Used Recombinant Albumin in ERVEBO to Establish a Novel Excipient Pathway — Regulatory pathway for qualifying rHSA as a novel excipient in injectable formulations.
Journal Articles (DOI Links) Rapid Quantitation of SARS-CoV-2 Antibodies Using an Electrochemical Sensor — Peer-reviewed application of Exbumin as a BSA replacement in electrochemical biosensor assays.
Blog Replacing the “Necessary Evil”: Recombinant Human Serum Albumin as a Chemically Stable Alternative to Polysorbates in Biopharmaceutical Formulation — Polysorbate degradation mechanisms and the case for rHSA as a chemically stable alternative.
Blog Albumin in Drug Delivery: Cancer’s Unexpected Achilles’ Heel — How albumin nanoparticles bypass MDR1 efflux pumps in cancer cells — Abraxane, GLP-1 agonists, and siRNA conjugates.
Blog Why Do Some Biologics Cross the Finish Line—While Others Crash and Burn? — Why CMC stability and excipient choices derail late-stage biologics.
News InVitria Launches Optibumin 25 rHSA — Optibumin 25 launch announcement.