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Protein & peptide formulation

Given the unstable nature of proteins and peptides, optimizing the stability of such therapeutics is a critical yet challenging objective of any drug development program. Resolution of such challenges enables their full therapeutic potential to be exploited, thereby ensuring optimal treatment options.

Formulation challenges

Safety and activity can be impaired by loss of “integrity” of the formulated product. Proteins and peptides indeed are only marginally stable and can undergo degradation via several mechanisms:

  • Hydrophobic interactions and peptide fibrillation may lead to aggregates and sub-visible particles, resulting in reduced efficacy and increased immunogenicity.
  • Binding to surfaces can cause structural changes resulting in self-association and/or aggregation. Further to this, non-specific adsorption to drug containers may cause material loss and incorrect dosing.
  • Chemical stress, such as degradation by oxidative species, can result in 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.

Choosing the right formulation strategy

Companies often work within a standard toolbox of excipients for formulation development. Although many of these agents are effective stabilizers, their use requires careful consideration in terms of local toxicity and potential immunogenicity. Often the outcome is a cocktail of excipients. In some instances, it is quite difficult to combine the various “ingredients” to reach the levels of stabilization needed. As formulation becomes increasingly complicated to achieve, there is an equally increased need for advanced solutions.

Albumin is nature’s own stabilizer, with in vivo functions to transport and protect vital molecules. Our recombinant human albumin, Recombumin® exploits albumin’s multifunctional properties as an effective, versatile stabilizer. It is particularly suited as a leaner formulation approach of biological drugs, such as proteins or peptides, not readily stabilized using traditional formulation strategies.

Read more about albumin in protein or peptide formulation in our scientific library

 

CONTACT

Albumedix Ltd.
Mabel Street
The Meadows
Nottingham
NG2 3ED, United Kingdom
Tel: +44 115 9553379
info@albumedix.com

 

Albumedix - Dedicated to Better Health

Albumedix is a science-driven company and recognized leader of best-in-class albumin-enabled solutions. Established in the UK in 1984, with a mission to empower excellence, Albumedix has supported its life-science partners to deliver hundreds of million safe doses of clinical and marketed therapeutics, globally. Albumedix’ solutions include the world’s only USP-NF compliant recombinant human albumin (Recombumin®), client-centric development and compliance services and drug-enhancing technologies (Veltis®). By always striving for more and collaboratively challenging status quo, Albumedix enables the development and commercialisation of advanced therapies and next-generation biopharmaceuticals to the benefit of people worldwide.

 

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