Albumin for Vaccine Stabilization

Recombumin^®: A Multipurpose Stabilizer

Recombumin^® recombinant human albumin (rAlb) can coat surfaces, inhibiting non-specific adsorption of vaccines throughout manufacture, formulation and storage. It also protects against aggregation and particle formation in vaccines. The free thiol group defends against oxidative stress stemming from free radicals.

Suitable for a Variety of Vaccines

Essentials of the Vaccine Production Procedure

Recombumin^®, an adaptable stabilizer, boasts the following properties:

• Freely coats surfaces and inhibits non-specific adsorption of sticky vaccines during downstream processing (DSP) and final formulation
• Inhibits aggregation formation throughout DSP and final formulation
• Shields fragile particles against shear stress during processing
• Maintains stability of vaccines during freeze and thaw
• Has the capacity to boost long term stabilization and enhance cold chain process

Prevention of Non-Specific Adsorption

• Albumin freely absorbs to both hydrophobic and hydrophilic surfaces and maintains its attachment, even after washing and over extended time periods.
• Coating of the surface is usually managed with just one layer of recombinant albumin
• Loss of material can result in lack of confidence in administered dose
• Adverse effects may occur as a result of imprecise dosing, surface induced aggregation or variations in higher order structure of the drug
• More hydrophobic surfaces lead to more pronounced adsorption
• Lowered efficacy is also a risk

Albumin has a predisposition to cover surfaces and the protein will cover both hydrophobic and hydrophilic surfaces. Historically, albumin has been used to cover the surfaces of medical devices to increase their biocompatibility. Studies have shown spontaneously formed albumin coverage to be in the order of a single albumin molecule in height, with only 1-2 mg albumin needed to cover 1 m2 of surface. This property is utilized for low dose/high potency drugs, where the dose could otherwise be difficult to control due to its surface adsorption during production, handling and storage. Another effect of albumin covering the surfaces is that it can reduce surface-induced unfolding and aggregation events of the API.

The following experiment showcases the effect of Albumedix’ rAlb on non-specific adsorption to increase API recovery.:TGF-β3 at 0.2 µg/mL was incubated in polypropylene containers with variable quantities of Recombumin^® showing that even at very low concentrations of Recombumin^® the recovery of TGF-β3 was significantly increased.

The analysis method for determining API recovery was reverse-phase HPLC.

Suppression of Aggregation

Recombumin^® possesses two important properties for the prevention of biotherapeutic aggregation.

• Firstly, it binds promiscuously using both ionic and hydrophobic interactions protecting otherwise exposed surfaces eligible for aggregation.
• Secondly, by dispersing uniformly throughout solution Recombumin^® affords an insulating quality which minimizes unwanted protein-protein interactions.

Its properties in this respect are illustrated in below graph by the reduced generation rate of insoluble aggregates, compared to other excipients.

Suppression of aggregation - Malaria example: rAlbumin suppresses FC27 aggregation more effectively than polysorbate 80, glycine or PEG

Recombumin^® boasts commercially established stabilization performance in both marketed and late-stage clinical and vaccine candidates. It is an adaptable stabilizer, suitable for challenging vaccine products, and has been validated by leading regulatory agencies.

It offers unmatched quality in meeting USP-NF and cGMP standards. With its consistent and assured production from a dependable manufacturer, it delivers long-term supply security for users, and comes with expert regulatory and technical guidance.

Customer Case Story: Merck

Recombumin^® is employed to produce Merck’s M-M-R^® II and ProQuad^® vaccines for inoculation against measles, mumps, rubella, and varicella virus infections in children ranging from 1 to 12 years. As a result, an extremely high level of safety is considered compulsory for this product by the regulatory authorities.

With every dose containing up to 0.3 mg of albumin, Merck chose to integrate Recombumin into the M-M-R II vaccine in 2006. Over 120 million doses of the vaccine have since been administered across the globe.

About Albumedix Ltd.

Too many people battle with diseases that keep them from living a full life. Healthcare professionals work hard every day to provide these people with better therapies. Together with partners, Albumedix utilize its albumin-based drug enhancing products and technologies to enable the development of more effective treatments.

With more than 30 years of experience, we are proud to be recognized as the world leader in recombinant human albumin products and technologies.

As the highest quality recombinant human albumin products ever developed, Albumedix enables the effective formulation of otherwise hard-to-stabilize drugs, cell therapies, and vaccines.

Our albumin-based technologies offer new ways of optimizing drug dosing and enhancing therapeutic performance by increasing the half-life, payload capacity, and tissue specific delivery of active pharmaceutical agents. This results in simpler treatment regimens, better performance, and, ultimately, improved patient outcomes.

Albumedix is headquartered in Nottingham, UK, with both research and large-scale manufacturing facilities. We are all committed to improving patient quality of life and are just as passionate about albumin and albumin-enabled therapies today as we were when we started 30 years ago.

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