At Anilocus, we provide preclinical allergy CRO solutions for evaluating the safety and efficacy of immunotherapies. Our team understands the vital role of nonclinical studies in drug development. With a focus on detail and reproducibility, we provide comprehensive efficacy and safety assessments to support the discovery and development of innovative therapeutics.

FDA Review Process for Nonclinical Studies

We are well-versed in the FDA’s expectations and requirements for nonclinical studies. We can guide you through the process, ensuring your studies meet the necessary standards and regulations.

Our Preclinical Food Allergy CRO Services

We offer a range of preclinical contract research services tailored specifically for the assessment of immunotherapies. Our services include:

Study Design and Protocol Development

Our team of immunologists will work closely with you to develop a comprehensive study design and protocol that meets your specific research objectives. We take into consideration factors such as allergen selection, dosing regimens, and study endpoints to ensure the most accurate and reliable data collection.

Animal Model Selection for Allergy Research

We have extensive experience in utilizing animal models of immunoglobulin-mediated food allergyand evaluate the safety and efficacy of monoclonal anti-immunoglobulin antibody treatments. Our team can help you select the most appropriate animal models, whether it’s mice, rats, or other relevant species, to ensure the translation of your research findings in preparation for clinical trials.

In Vivo Experiments for Allergen Research

We conduct in vivo experiments to assess the safety and efficacy of immunotherapies for food allergies. Our services include allergen challenge studies, immunotherapy administration, monitoring of clinical symptoms, and collection of relevant biological samples for in-life and terminal analysis.

Immunological Assessments

We conduct immunological assessments that provide a comprehensive understanding of the immune response to immunotherapies. We offer a wide range of immunological techniques, including antibody assays, cytokine profiling, flow cytometry, and histopathological analysis.

Data Analysis and Reporting

Our team will perform data analysis using standard statistical methods. We provide detailed Nonclinical Study Reports summarizing the study findings that can be included in the Common Technical Document (CTD). The reports include data interpretations, conclusions, and recommendations for future directions.

Why Choose Anilocus?

Choosing Anilocus as your allergy CRO offers several advantages:

  • Expertise: Our team possesses extensive knowledge in the field of food allergies and immunotherapy.
  • Quality Assurance: We adhere to strict quality assurance protocols to ensure the integrity of all research findings.
  • Regulatory Compliance: We are well-versed in FDA regulations and guidelines for nonclinical studies, ensuring the research meets the necessary standards for Good Laboratory Practices (GLP).
  • Customized Solutions: We tailor our services to meet your specific research objectives, providing personalized solutions for your immunotherapy development.

Contact us for a free quote! Let us develop a study plan designed for your research needs.

References

  1. Andrade EL, Bento AF, Cavalli J, et al. Non-clinical studies in the process of new drug development – Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies. Braz J Med Biol Res. 2016;49(12):e5646. Published 2016 Dec 12. doi:10.1590/1414-431X20165646.
  2. Strovel J, Sittampalam S, Coussens NP, et al. Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies. 2012 May 1 [Updated 2016 Jul 1]. In: Markossian S, Grossman A, Brimacombe K, et al., editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences.
  3. Andrade EL, Bento AF, Cavalli J, et al. Non-clinical studies in the process of new drug development – Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies. Braz J Med Biol Res. 2016;49(12):e5646. Published 2016 Dec 12. doi:10.1590/1414-431X20165646.
  4. Maggi E, Vultaggio A, Matucci A. Acute infusion reactions induced by monoclonal antibody therapy. Expert Rev Clin Immunol. 2011;7(1):55-63. doi:10.1586/eci.10.90.