Immunogenicity testing unveils the capacity of a biotherapeutic to elicit an immune response triggered by antigens, and these crucial evaluations demand a tailored approach. From crafting study designs to developing, validating, and analyzing methods, Vipragen possesses specialized expertise and capabilities to execute thorough immunogenicity testing across all stages of your specific therapy's development.

Development of Immunogenicity Assays

The imperative nature of immunogenicity testing spans from preclinical models to clinical samples, constituting a crucial aspect throughout the development process. Whether in the development of vaccines, biologics, or gene therapies, immunogenicity testing plays a pivotal role in gauging the antibodies produced in response to your drug. This comprehensive assessment enables a confident evaluation of efficacy and safety. Our seasoned team employs a tailored approach to your immunogenicity testing program, considering your drug's mechanism of action (MOA), regulatory mandates, and overall program requirements.

Capabilities in Immunogenicity Services

As the demand for immunogenicity testing persists throughout the developmental stages of your therapeutic, it becomes crucial to have access to testing facilities that align with your specific requirements. Vipragen is well-equipped to facilitate studies based on your timelines. Our capabilities extend to various platform technologies, including:

• » Enzyme-Linked Immunosorbent Assay (ELISA)
• » Meso Scale Discovery (MSD)/Electrochemiluminescence (ECL)
• » Flow cytometry
• » Gyrolab

This diverse array of platforms ensures the flexibility and adaptability needed to address the unique aspects of your immunogenicity testing, providing comprehensive support throughout your therapeutic development journey.

Immunogenicity Testing Team Advantages

Our team combines extensive immunology expertise, a wealth of drug development experience, and a high degree of flexibility to tailor and implement the optimal testing program for your therapeutic. Here are the advantages of collaborating with our specialists:

Diverse Array of Immunogenicity Assays:

Our proficiency covers a broad spectrum of immunogenicity assay types, ensuring a comprehensive evaluation.

Adaptive ADA Strategies:

We possess the capability to adapt Anti-Drug Antibody (ADA) strategies, allowing for flexibility and responsiveness to evolving needs.

Specialization in Neutralizing Antibodies (nAb) Assays:

Our team excels in conducting specific Neutralizing Antibodies (nAb) assays, offering precision in evaluating therapeutic responses.

Statistical Support for Cut Point Calculation:

We provide robust statistical support for the calculation of immunogenicity testing cut points, enhancing the reliability of assessments.

Immunogenicity Testing as an Efficacy Measure for Vaccines:

Recognizing the pivotal role of immunogenicity testing, particularly in the context of vaccines, we ensure its application as a key measure of efficacy.

By choosing to collaborate with our specialists, you gain access to a well-rounded team capable of navigating the complexities of immunogenicity testing, ensuring a tailored and effective approach for the success of your therapeutic development.