Skip links

Vaccine Development

Empowering Immunity: Enabling Breakthroughs in Vaccine Development for a Healthier Future

From traditional vaccines to an era of novel approaches to preventive and therapeutic vaccine-like products, coupled with new adjuvants and delivery systems, knowing the right approach to demonstrate nonclinical proof-of-concept and safety is essential. Our team of expert immunologists, toxicologists, and program managers will help you develop a tailored nonclinical program for your vaccine candidate.

vaccine development challenges

Challenges Within Vaccine Development

Because our team has been in the industry for so long, we understand that vaccine development programs have many challenges. The following roadblocks are frequently encountered during the development:

  • Different vaccine types follow different regulatory pathways and require customized nonclinical programs.
  • Developing a suitable in vitro potency assay is challenging.
  • Toxicology programs for vaccines are often streamlined vs. other modalities but always require ‘case-by-case’ thinking and relevant endpoints based on the vaccine type.
  • Selecting the appropriate species depends on the vaccine candidate’s immunological mechanisms and the species’ permissiveness or relevance.
  • While vaccines are generally well tolerated locally and systemically, theoretical and actual risks require consideration and assessment depending upon the mechanism(s) of action.
  • Efficacy models are neither standardized nor validated and may produce conflicting results.
  • Immunogenicity models are of limited informative power for humans.
  • Surrogate markers of efficacy are to be identified to ensure the feasibility of pivotal clinical trials.
Contact Us


Infectious Diseases or Cancer Vaccines, Strengthen Your Application Path With KreaMedica’s Solutions

  • Our experts understand the regulatory requirements for nonclinical and clinical development of your candidates.
  • We assist you in selecting the appropriate model(s) for your program based on the composition, mechanism, and indication of your vaccine candidate by integrating relevant immunological and safety endpoints to enable key decision-making.
  • Our team of experts will help you design your preclinical and clinical studies for efficient vaccine development up to NDA/MAA.
  • Our scientific project managers align potential multisite activities, foresee challenges, and align solutions collaboratively with relevant stakeholders.
Contact Us
vaccine development consultants

Truth in Numbers


Development Programs


Sponsors Who Trust Us


Years Combined
Industry Experience


Don’t take our word for it.

Contact Us

Start Your Biotech Journey

Learn More