Comprehensive support for vaccine development programs.
Specialized bioanalytical support across vaccine generations — from infectious agent-based vaccines to the latest nucleic acid and vector-based platforms. We combine deep scientific expertise with regulatory know-how to deliver the critical data you need to characterize immune responses, assess potency, and ensure safety throughout your vaccine’s lifecycle.
Vaccine development: support for a broad range of formats
With over 100 years of collective experience, our GLP, GCLP, and GMP-compliant scientists bring unmatched expertise in immune-based methods and cell-based assays. We support:
- Generation 1 Vaccines: Infectious agent-based vaccines requiring immunologic characterization and potency testing.
- Generation 2 & 3 Vaccines: Including recombinant proteins, virus-like particles (VLPs), nucleic acid and vector-based vaccines, as well as monoclonal antibodies targeting viral agents.
- Virus Neutralization & Mode of Action: Cell-based assays using primary cells or cell lines to demonstrate mechanism of action.
Our team develops, optimizes, and validates assays to ICH standards, providing phase-appropriate support from early development through pre-commercial and Phase III studies.
Assessments
BioAgilytix, working with an array of both emerging and large pharmabio customers, provides robust, compliant bioanalytical assessments for the diverse range of vaccine varieties in development today. With leading expertise in complex biologics and a broad suite of advanced platforms, we can apply the optimal, phase-appropriate method to meet your unique vaccine program needs.
Expertise
BioAgilytix’s GLP, GCLP, and GMP staff have more than 100 years of collective experience in developing immune-based methods and cell-based assays to measure potency, efficacy, and safety endpoints which we leverage in testing for a myriad of vaccine types. We validate assays to ICH standards and apply phase-appropriate criteria to support your vaccine program lifecycle from early phase development through pre-commercial/Phase III efforts. We’ll work closely to define your specific assay requirements and facilitate selection of the best platform for everything from short-term feasibility studies to long-term robust product release testing.
Full range of phase appropriate methods for vaccine assessments
Our experience is deep across the range of assays below performed under GxP regulations. Through these comprehensive assessments we are able to help ensure your vaccine products are well-positioned to successfully advance down the development and approval pathways.
Optimal platforms for vaccine assays: plate-based methods
The science behind vaccines has advanced substantially in recent years – as have regulatory expectations. Potency assays have evolved from simple titers to relative potency determinations to demonstrate appropriate control of the product. The 3Rs initiative is also driving more vaccine testing to move from in vivo animal models to in vitro using epitope-targeted ELISAs or cell-based assays with immune-pertinent systems.
BioAgilytix’s expertise in developing a range of ELISA and cell-based assays for biologics and gene & cell therapies on a broad set of platforms, paired with our specialization in immunology and with ADA and NAb assays, ensures your vaccine products are well-positioned to successfully advance down the development and approval pathways.