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