Our project managers are dedicated, full-time, experienced scientists
Get end-to-end support from our committed teams through the planning and implementation of your custom vaccine and biologics testing. Working directly with you, project managers are on hand to advise on study design and review protocols to ensure adherence to regulatory guidelines.
- Scientific consultation
- Protocol development
- Study implementation
- Data collection
- Internal regulatory approval
- Report preparation
- IND-application support
In Vivo Immunogenicity Studies
A variety of molecules and cellular therapeutics can be immunogenic, so it is vital to conduct immunogenicity testing as part of your preclinical safety program. Indeed the FDA, EMEA and other regulatory agencies recommend thorough immunogenicity assessment of your compound’s immunogenic potential. We can help you to assess the immunogenicity of your biologic in a three-tiered strategy:
- Screening
- Confirmatory
- Titer assessment
In Vivo Challenge—Efficacy Studies
A challenge—efficacy study is the acid test for showing the efficacy of your vaccine, and we know how important it is to get them right. Choose a partner with a wide range of capabilities for quantitative assessments of immune response, including analysis of in-life and post-life samples.
Validated stocks of well-characterized infectious challenge agents and models are constantly expanding. Recently added are:
Indication
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Model
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Endpoints
|
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Staphylococcus aureus (MRSA)
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Mouse kidney abscess
|
Clinical symptoms
Bacterial load
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Clostridium difficile
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Hamster
|
Clinical symptoms
Bacterial load
Histopathology
|
Influenza
|
Ferret
|
Clinical symptoms
Viral load
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Respiratory syncytial virus (RSV)
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Cotton Rat
|
Clinical symptoms
Viral load
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