During drug discovery and development, it is essential to understand and define how molecules interact with the immune system. As a drug moves through the discovery process, AmplifyBio’s scientists use information and insights gained through immunology and immunotoxicology assessments to provide vital support and strategic guidance for any drug development program from discovery to clinical.
Immunogenicity poses a significant concern for biologic drugs, potentially impacting safety and effectiveness. When considering immune-mediated adverse effects of biological drugs, a comprehensive understanding of the interplay between adaptive and innate immune responses is paramount. Therefore, finding a partner capable of supporting your immunogenicity testing strategy and keeping it up to date with stringent safety and regulatory standards is imperative. At AmplifyBio, our team understands the complexities of the immune system that can affect a product’s pharmacokinetics, pharmacodynamics, safety, and efficacy.
Even therapeutics with mechanisms of action independent of the immune system can have off-target effects on immune function. As such, it is crucial to identify potential modulation of the immune system and de-risk compounds during the drug development journey. AmplifyBio offers a wide variety of immunological tests that can be tailored fit for purpose and expertise. Our scientists will work with you to collaborate on projects to share data and ideas, altering the plan as needed. Amplifybio can also onboard the customized assays for use in the study and a plan to collect data for future use in generating models.
Even therapies with mechanisms of action unrelated to the immune system can induce off-target effects on immune function. Therefore, detecting potential modulation of the immune system is essential to mitigate risks associated with compounds throughout the drug development process.
AmplifyBio boasts the expertise and an extensive technology portfolio spanning basic discovery research to precise immune monitoring applications. Our methods are qualified and standardized across all AmplifyBio sites to ensure accuracy and reproducibility.
Comprehensive service programs for developing Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial and offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing in an integrated, innovation-rich environment that exceeds the value proposition offered by traditional CDMO and PDMO contract models.