Pre-clinical studies are the cornerstone of drug development, laying the groundwork for clinical trials and eventual regulatory approval. Alta Stomatology is a leading research and development company specializing in developing drugs for oral diseases. Our multidisciplinary team with extensive experience in vaccine research and development, can design a series of pre-clinical studies to evaluate the safety, efficacy, and pharmacokinetics of potential vaccines. If you have any needs, please feel free to contact us.
Immunogenicity studies represent a crucial component of vaccine development, aiming to assess the immune response elicited by candidate vaccines. At Alta Stomatology, our immunogenicity studies meticulously evaluate the ability of oral disease vaccines to stimulate robust immune responses, particularly targeting pathogens associated with prevalent oral diseases such as periodontitis and dental caries. Our research teams simulate conditions identical to when the vaccine is introduced into the human body. This approach lets us understand the kind and extent of immune response the vaccine triggers, and the duration of immune responses.
Toxicity studies are imperative for ensuring the safety profile of vaccine candidates before advancing to clinical trials. Alta Stomatology can provide you with comprehensive toxicity studies, including acute toxicity studies, subacute and subchronic toxicity studies, genotoxicity and mutagenicity studies, and reproductive and developmental toxicity studies. During these studies, we determine the dosage that causes a toxic response, the nature of the harm, recovery patterns, and potential factors affecting these patterns. Through meticulous toxicological assessments, we mitigate potential risks and help our customers develop safe and well-tolerated oral disease vaccines.
Biodistribution studies elucidate the absorbed, distributed, metabolized, and excreted of vaccines within the body. At Alta Stomatology, our biodistribution studies employ state-of-the-art imaging techniques and molecular tracking methodologies to monitor the distribution of vaccine antigens following administration. By understanding the pharmacokinetic profiles of oral disease vaccines, we can optimize dosing regimens and enhance therapeutic efficacy while minimizing off-target effects.
Efficacy studies serve to validate the vaccine candidate's capacity to confer protection against oral diseases in relevant animal models. At Alta Stomatology, we use clinically relevant endpoints such as reduction in bacterial load, inhibition of biofilm formation, and preservation of periodontal tissue integrity, we demonstrate the vaccine's ability to prevent infection, attenuate disease progression, and promote oral health outcomes. Our holistic approach to efficacy assessment integrates microbiological, immunological, and histopathological analyses, yielding robust evidence of vaccine efficacy and guiding subsequent clinical development efforts with precision and purpose.
Our team comprises world-class scientists and researchers with unparalleled expertise in oral microbiology, immunology, pharmacology, and toxicology, enabling us to execute pre-clinical studies with precision, insight, and innovation.
We boast state-of-the-art facilities equipped, enabling comprehensive evaluation of vaccine candidates across multiple pre-clinical endpoints, from immunogenicity and toxicity to biodistribution and efficacy.
We prioritize translational relevance in our pre-clinical study design, utilizing clinically relevant animal models and endpoints to generate data that is predictive of human outcomes, thereby facilitating seamless transition to clinical development.