The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional Vaccines - Preclinical and clinical trials have demonstrated proof-of-concept for the LT-IS patch. - BioPharm

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The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional Vaccines
Preclinical and clinical trials have demonstrated proof-of-concept for the LT-IS patch.


BioPharm International



Figure 8. Thermal cycling study for packaged dry LT patches. Conditions were modeled for products targeting both refrigerated and room temperature storage. The temperature cycling regiment is listed in the table. LT was extracted from patches and quantified by SE-HPLC (top panel) and assessed for potency by Y-1 cell assay (bottom panel). SE-HPLC results are reported as the LT percent of the label claim and are the average of 3 patches. Potency results are reported as log, μg-1. Four control groups held at a constant temperature for the study duration were run. HPLC and Y-1 results from thermal cycled samples were not significantly different from those reported for control samples kept at 2-8 C (as determined by student t-test, data not shown).
Figure 8 also shows the results of the thermal cycling study as measured by the SE-HPLC content assay (top panel) and Y-1 cell potency assay (bottom panel). After 12 days of thermal cycling between -20 and 25 C and -20 and 40 C, the averaged data shows no statistically significant decrease in Y-1 cell potency or LT content in the patches. The results of this study suggest the possible use of expanded shipping conditions for this product (beyond 2–8 C).

Water Activity of The Dry Patch

Water activity, rather than moisture content, is used commonly by microbiologists and food technologists to assess criteria for safety and quality of food products.21–23 Water activity, aw, measures the free water in a product (i.e., in our case, the dry LT patch); whereas, moisture content measures both free and bound water. According to USP <1112>,24 when the water activity of a product decreases below 0.60, microorganisms cannot obtain the water necessary to support their growth. Most bacterial growth is inhibited below aw~0.91; most yeasts cease growing below aw=0.87, and most molds do not grow below aw=0.80. The aw of the dry IS patch was determined by LabMaster-aw (manufactured by Novasina Instruments) and found to be around 0.35.03, which is significantly lower than the absolute limit of microbial growth of aw=0.60. Thus, the dry IS patch formulation will not support microbial growth during storage in a nitrogen-purged sealed foil pouch.


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