Maximizing the stability of a therapeutic protein, peptide or vaccine is not an easy task and therefore, a critical objective of any drug development program. Physical and chemical instability of biological drugs and vaccine formulations are a source of dosage form inefficacy and also undesirable immunogenic responses. Therefore, optimizing the stability of a therapeutic drug during final drug formulation, handling and storage is imperative to producing a safe final product with an appropriate shelf-life. 

Albumedix's ground-breaking Recombumin®, recombinant human albumin products provide drug formulators with a unique alternative to traditional stabilizers when working with challenging molecules such as complex drug conjugates, high-concentration biotherapeutics, highly potent drugs or instable therapeutic peptides. By utilizing the versatile properties of Recombumin®, drug developers can overcome several critical formulation challenges:

• Formation of aggregates and sub-visible particles during product storage is a major concern for formulation scientists due to the potential for loss, reduced efficacy, and increased immunogenicity of the product. Through various modes of action, Recombumin® protects drug and vaccines from aggregation and particle formation. For example, the unique technology has been shown to reduce particle formation (2-100um size) in high-concentration monoclonal antibody formulations and to stabilize various peptide and protein therapeutics by hindering fibrillation and protein aggregation, respectively.

• Binding of biotherapeutics to surfaces during manufacture and storage can lead to structural changes in drug and vaccine products, resulting in self-association and/or aggregation. As drug developers know, the resultant effect is a decrease in drug concentration in solution, which potentially may alter the pharmacokinetics, stability, and immunogenicity of the product. To limit active pharmaceutical ingredient loss due to non-specific adsorption, Recombumin® acts to prevent active product adsorption due to its high interfacial activity, binding to both hydrophobic and hydrophilic surfaces.

• Oxidation of biological drug products can lead to a range of functional changes such as altered binding activities, increased susceptibility to aggregation and proteolysis, and increased or decreased uptake by cells, as well as altered immunogenicity. Using the conserved free thiol on Recombumin® the reductive pool available in solution is significantly increased, protecting co-formulated biological drugs against oxidative stress.

Through working closely with partners and collaborators, and using our collective scientific, technology and regulatory expertise, Albumedix strives to bring valuable yet initially unstable drug candidates to market. By combining Recombumin® with our partners' innovative drug candidates, the technology has been established as a commercially validated, safe stabilization solution across a broad range of drug types and indications. Read more.