Maintaining vaccine stability
Vaccines continue to be an important field of pharmaceutical research, offering valuable therapeutic and prophylactic patient benefits. As more viral vector based as well as cancer vaccines are reaching patients, complexities are increasing and more wide spread diseases are being addressed - Now developers are facing a new set of production, manufacturing and stability challenges.
Like other biologics, vaccines are susceptible to environmental stress, such as temperature changes and physical strain. Therefore, maintaining stability during manufacturing, storage and delivery of vaccines to patients can be a difficult task.
For example, vaccines targeting developing countries often face elevated temperatures, making thermal stability very important. The ability to maintain stability in such conditions may lead to reduction in cost and more effective vaccination programs to people worldwide. Even when freeze-drying is chosen as a formulation option, reduction of cell viability and vaccine efficacy can occur for temperature sensitive vaccines.
The choice of excipients is therefore critical to minimize the detrimental effects responsible for vaccine inactivation [Life Science Journal 6 (2009) 13-17].
Overcoming vaccine challenges using albumin
- Protection from sheer stress: Recombinant human albumin provides an insulating effect on viral vector vaccines, protecting against physical damage during manufacturing and handling, ultimately maintaining potency and efficacy.
- Prevention of surface adsorption: Loss of vaccine particles on surfaces during downstream processing can cause significant loss of yield. Furthermore, adsorption to final vaccine containers may result in inadequate dose control. By coating surfaces with Recombumin, these issues may be prevented.
- Thermal stability: Thermally sensitive vaccines can lose viability and efficacy during freeze-thaw and/or fluctuating temperatures under transportation. Driven by albumin’s high thermal stability, Recombumin has shown to extend this quality to co-formulated vaccines.
These properties of Recombumin® have been shown to be applicable across a broad range of vaccine constructs, such as live attenuated vaccines, whole-inactivated, sub-unit vaccines, viral vector vaccines, virus like particles (VLP’s) and enveloped vaccines.