Vaccines Development Testing

Access a comprehensive suite of discovery vaccine testing services, enabling the development of human and veterinary vaccines against viral and bacterial pathogens. With more than four decades of experience working with a variety of vaccine types within a full range of in vivo and in vitro services, Covance can be an ideal partner for all your vaccine development needs.

Vaccine development & solution-based discovery capabilities

We work with all common vaccine types: subunit, live/attenuated, inactivated and toxoid.

  • In-vitro capabilities
    • Humoral immune response analysis:  Analyze various antibody response types in the well-equipped laboratories using ELISA, neutralization assays, HAI and other tests
    • Cell-mediated immune response: Decipher Th1 and Th2 responses by ELISpot in a dedicated tissue culture facility 
  • In-vivo capabilities
    • Immunogenicity studies: Select from a variety of host species ranging from rodents to NHPs with rapid study starts and scalability from a few to a large number of animals
    • Efficacy/challenge: Evaluate your vaccine's efficacy in our vivariums supporting up to BSL2 pathogens in custom-developed or standard research models
close up of scientist hand with test sample in lab

Immunogenicity Studies

Immunogencicity studies are a combination of in-vivo and in-vitro services providing you with a complete evaluation of the immunogenicity of your test vaccines. We work with you as part of a comprehensive development plan to identify a suitable host species (based on the nature of the vaccine) and to recommend sample analysis methods. 

Efficacy/Challenge Studies

Following satisfactory immunogenicity results, efficacy or challenge studies can be conducted using a standard or custom animal model. Pathogens up to BSL2 can be tested in our state-of-the-art vivariums in studies ranging in size from small, pilot studies to larger, complex designs. Samples originating from these in-vivo studies can be transferred to our laboratories for further analysis.     


Need to establish proof-of-concept?

Need to induce a specific immune response?

Need to find the most effective adjuvant for your vaccine candidate?

Need to maximize study reproducibility?

Access the following studies:

  • Animal model selection
  • Animal model development
  • Minimum protective dose (MPD) determination
  • Adjuvant selection and safety

Need to confirm proof-of-concept?

Need to qualify and validate facilities, technicians, animals and procedures for regulatory compliance?

Access the following studies:

  • Immunogenicity
  • Dose titration
  • Efficacy
  • Immunotoxicology safety
  • Stability
  • Qualification
  • Validation
  • Equivalency testing
  • Preparation of quality serum

Need to use qualified facilities staffed with validated technicians?

Need to ensure uninterrupted release of your vaccine to the market?

Need to maximize batch-to-batch reproducibility of your vaccine?

Access:

  • Potency testing
  • Stability testing

Your vaccine studies will take place at our two state-of-the-art, ABSL 1 & 2-certified vivariums. You will benefit from significant capacity to start thousands of research models concurrently with 24/7 security and advanced control systems to regulate environmental parameters. Our vivariums are all AAALAC-accredited and staffed with specialized and highly trained team members. Learn more about our committment to animal welfare. 

Choose from small model or large model species or work with us to identify a custom model. Scientists and technicians are experienced with tissue culture and immunology, and in working with:

  • NZW Rabbit
  • Dutch Belted Rabbit
  • Horse
  • Cattle
  • Sheep
  • Non-human Primates
  • Dog
  • Cat
  • Goat
  • Chicken
  • Guinea Pig
  • Mouse
  • Rat
  • Hamster
  • Ferret
  • Pig

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

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

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

Model

Endpoints

Staphylococcus aureus (MRSA)

Mouse kidney abscess

Clinical symptoms

Bacterial load

Clostridium difficile

Hamster

Clinical symptoms

Bacterial load

Histopathology

Influenza

Ferret

Clinical symptoms

Viral load

Respiratory syncytial virus (RSV)

Cotton Rat

Clinical symptoms

Viral load

“I want to extend my sincere thanks to Covance for your performance demonstrated during the challenge phase of our preclinical vaccine study. By all accounts the quality and workmanship of the service provided has been exceptional. The efforts of your management team to work expeditiously, intelligently and honestly has been key for successful execution of this challenging experiment. It has truly been a pleasure to work with Covance and we look forward to continuing this practice in the future.” 

– Large Pharma Client