Reasons for dating biological immunization preparations
A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins.The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and recognize and destroy any of these microorganisms that it later encounters.Abstract: In spite of enormous efforts there have been no solutions to date for preventing/terminating chronic disorders of humans by vaccination or drugs.Yet it is well understood that if the target antigen (ag)...This document supplements the ICH Harmonised Tripartite Guidance, , as well as the Health Canada Guidances for Industry on the preparation of various types of drug submissions in the CTD format.In addition, this document references other available domestic Quality guidances that can be useful in preparing the technical or scientific information required for certain sections of the submission.
Stand-alone units that only refrigerate or only freeze are recommended by CDC.
Furthermore, the review addresses the issue of local reactions in the context of injection route and local tissue disturbance.
Possible new applications of aluminium adjuvants in, for example, combined aluminium-adsorbed protein and DNA oligonucleotide vaccines as well as the possible use of aluminium adjuvants in combination with IL-12 to stimulate Th1-type immune responses are mentioned.
Combination refrigerator/freezer units are less capable of simultaneously maintaining proper storage temperatures in both compartments.
If a combination refrigerator/freezer must be used, only refrigerated vaccines should be stored in the unit, and a separate stand-alone freezer should be used for frozen vaccines.