Prophylactic Vaccine Safety and Efficacy Studies

Pharmacology

We have wide-ranging expertise in vaccinology-focused pre-clinical models where immunogenicity can be assessed, and efficacy tested in disease models. Challenge/protection studies can be performed with a range of infectious agents; both viral and bacterial, including influenza, HSV, RSV, and Streptococcus pneumoniae. Pre-clinical/pharmacology studies are non-GLP and can be conducted up to Biosafety Level 2 (BSL2) conditions. A broad spectrum of in-life and complex endpoint analyses can be performed to assess efficacy and to identify biomarkers, which can be personalized and refined based on your requirement. Our studies support all vaccine technologies used to target pathogens, oncology, or autoimmune disease including live/attenuated viruses, proteins/peptides, polysaccharide/conjugates, AAV, DNA/plasmid, mRNA/SaRNA (LNP), and adjuvant testing.

Bioanalysis (Method Development and Validation)

Non-Clinical Safety Evaluation

We have a large amount of experience with prophylactic vaccines intended to fight infectious disease, with a large number of studies that are conducted in accordance with World Health Organization (WHO) vaccine guidelines. Our vaccine toxicology studies include:

These studies can be conducted under non-GLP or GLP conditions and up to Biosafety Level 2 (BSL2) conditions, delivering results under high regulatory standards and at a competitive price. Our team has experience with the different vaccine technologies used to target pathogens including live/attenuated viruses, proteins/peptides, vectors, DNA/plasmid, mRNA/SaRNA (LNP), and +/- adjuvant.

Prophylactic Vaccine to Safety Timeline

vaccine timeline

 

Routes of Administration in Prophylactic Vaccines

Majority of prophylactic vaccines are given through the intramuscular route. However, we support all routes of administration including subcutaneous, intradermal, patch, and intranasal. Other routes we support are intravenous and inhalation which are rarely used for prophylactic vaccines.

Species

Species are selected on the basis of the immune system and for prophylactic vaccines are often performed in rabbits. Although other species may be used, including rats. We have technical capabilities across all species including, rabbit, rat, mice, hamster, and large animals.

Prophylactic Vaccine Capabilities:

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