VACCIPRO®: The gold standard in vaccine stabilisation

July
24, 2024

3 min

#AmazingGelatin

Vaccinations are among the most successful tools at the medical profession’s disposal, helping to prevent numerous infectious diseases such as measles, hepatitis and, more recently, Covid-19. The effectiveness of vaccinations relies heavily on their stability. Depending on the type of vaccine, the inclusion of stabilizing agents can be crucial for the protection of the active pharmaceutical ingredient. Many stabilizers in live, attenuated vaccines are enriched with protein excipients such as gelatin and human albumin. Gelatin is classified as GRAS (Generally Recognized As Safe) and is generally known to have an extremely rare incidence of anaphylaxis (one per 2 million cases) and is therefore considered to be a safe stabilizer [1]. As a key component for the lyophilization process, it helps safeguard vaccines from temperature-related effects. That’s why we at GELITA have developed a unique solution: VACCIPRO^®, a gelatin hydrolysate that is used by our customers to protect and thus enhance the stability of vaccines.

VACCIPRO^®: a unique solution

VACCIPRO^® is used for stabilizing antigens and other proteinaceous components. Through the triple-helical structure of collagen peptides, the fragile antigens are protected from denaturation and aggregation caused by environmental stresses such as temperature fluctuations and mechanical agitation. As well as this structural support, VACCIPRO^® offers another set of unique properties, which make it the preferred stabilizer for lyophilised vaccines:

Exceptional biocompatibility: by nature well-tolerated by the body, with low allergenic potential, making it safe for human and animal vaccine formulation.
Moisture control: acts as a hygroscopic agent, absorbing excess moisture from the vaccine and preventing crystal formation. This efficient moisture control helps to preserve vaccine stability over extended storage periods.
Protection: provides strong structural support, protecting antigens from damage.
Compatibility: compatible with diverse vaccine formulations.
Pure and consistent: produced with high levels of purity and consistent molecular weight control, it ensures reliable antigen stabilization
Sustainable and biodegradable: its biodegradable nature aligns with sustainability and safety principles. It undergoes enzymatic degradation, creating harmless byproducts within the body, thus ensuring safe use.

We produce VACCIPRO^® following relevant GMP guidelines. Analysis and release is in accordance with the requirements of the US Pharmacopeia and European Pharmacopoeia, and even exceed standards of the Federal Drug Administration for implantable devices. This level of compliance ensures that the vaccine stabilizer is recognised as the gold standard by leading global vaccine producers.