Inventprise’s proprietary scalable conjugation technology based on the Hydrazide-PEG-Hydrazide (Hz-PEG-Hz) linker designed to create specific, highly immunogenic, and broad-spectrum conjugate vaccines.
Our technology addresses the reduction in immunogenicity observed with high-valency PCVs by increasing the availability of antigenic polysaccharide epitopes. In addition, the PEG linker increases the carrier function, and suppresses the immune response towards the carrier by means of steric shielding.
The first step is the size reduction of the purified target capsular polysaccharide. The polysaccharide must be of a known molecular size prior to conjugation. The PS-to-carrier protein ratio is critical to the success of conjugation.
The purified carrier protein is derivitized using a proprietary process. We first activate the carrier protein preparing it for PEGylation, or the attachment of *PolyEthyleneGlycol. A a proprietary Hz-PEG-Hz linker is then attached to the carrier protein.
*PEG is a water-soluble, nontoxic, non-antigenic, biocompatible polymer that has been approved by the FDA for human intravenous, oral, and dermal applications.
The purified size-reduced polysaccharide is activated by means of *CDAP. CDAP activates the polysaccharides by reacting with carbohydrate hydroxyl groups (pH 7-9). The activated polysaccharide can now be functionalized with the dihydrazide linker thus completing the conjugation.
*CDAP - 1-cyano-4-dimethylaminopyridinium tetrafluoroborate
A buffer is added to maximize stability during storage.
Rotavirus is the leading cause of severe gastroenteritis among young children and is responsible for approximately 37% of deaths from diarrhea among children younger than five world wide. In low-resource settings, the lack of a cold chain for transport and storage affects the vaccine’s efficacy due to degradation of active material. Increasing the dose volume is undesirable for a pediatric vaccine.
We have developed an innovative thermostable low-volume oral rotavirus vaccine formulation that does not require refrigeration, is more stable, easier to administer and transport.
A proprietary blend of excipients are added to protect the rotavirus and confer thermostability during the freeze-drying cycle.
Lyophilized virus is ultra-milled to under 20 microns, in an inert atmosphere (N2).
This is an oral platform, and so a buffer system is required counteract stomach pH. The buffer and the lyophilized material is then suspended in MCT oil for further long-term stability and moisture-prevention. The final formulation is then homogenized.