Immunogenicity

Synergy Bioscience stands as a bastion of safety and efficacy in the realm of therapeutic development, particularly through our unmatched expertise in immunogenicity risk assessment. Our commitment to understanding and mitigating the immunogenic potential of therapeutic modalities is paramount in our operations, safeguarding patient well-being, and ensuring regulatory compliance.

Critical Immunogenicity Risk Assessment

Immunogenicity presents a complex challenge in drug development, with potential consequences ranging from negligible to life-threatening. At Synergy Bioscience, we prioritize the assessment of immunogenicity to ensure that therapeutic interventions are both safe and efficacious.

Comprehensive Immunogenicity Services

Our services encompass a full suite of immunogenicity assessments for an array of therapeutic modalities:

• Robust Testing for Large Molecules and ATMPs: We specialize in the immunogenicity testing of large molecules and Advanced Therapy Medicinal Products (ATMPs), addressing their unique challenges with precision.
• Detection of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs): Our assays are finely tuned to detect both ADAs and NAbs, offering insights into the potential for immune reactions to therapeutic agents.
• Cellular Immunogenicity Assessments: We employ advanced techniques to evaluate cellular immune responses, ensuring a holistic understanding of immunogenicity.
• Cytokine Production Measurement: By quantifying cytokine production, we can predict and evaluate the inflammatory response elicited by therapeutics.
• Control Antibody Generation and Reagent Labeling: Our meticulous oversight of surrogate positive control antibody generation and reagent labeling supports the integrity of our assays.
• Statistical Analysis for Cut Point Generation: Our data analysis rigorously supports cut point generation, ensuring the differentiation between immune response significance and background noise.


Your Immunogenicity Experts

Synergy Bioscience’s team of scientists are pioneers in characterizing immunogenicity in therapeutics, with deep expertise in both cell-mediated and antibody-mediated immune responses. Partnering with us means gaining access to:

• Regulated Data for Comprehensive Risk Assessment: We provide stringent, regulated data to back immunogenicity risk assessments across all therapeutic modalities.
• Global Trial Support: Our reach extends globally, with laboratories in the U.S., Europe, and Australia to support international trials.
• Decades of Immunogenicity Experience: With over 10 years in the field, our experience in immunogenicity risk assessment is extensive and continually evolving.
• Multi-Species Study Support: Our experience encompasses a variety of species, from rodents to humans and non-human primates, enabling cross-species insights and translational research.


Advanced Analytical Platforms

To keep pace with the complexity of modern therapeutics, we utilize specialized platforms for immunogenicity assessment:

• Sophisticated ELISA and MSD-ECL Systems
• High-throughput Gyrolab and Biacore
• Sensitive ImmunoCAP
• Comprehensive Flow Cytometry and Luminex Analysis


The Importance of Immunogenicity in Drug Safety

The implications of immunogenicity are significant in the development of biological drugs. Understanding the nuances of immune response — from the incidence and kinetics of Anti-Drug Antibodies to their clinical ramifications — is not just scientific rigor; it’s a patient-centric approach that enhances clinical management and therapeutic success.

At Synergy Bioscience, we are not just conducting assays; we are setting the standard for immunogenicity assessment. Allow us to be your trusted partner in navigating the complexities of immunogenicity, ensuring your therapeutics are synonymous with safety and efficacy.

To discuss how Synergy Bioscience can help you, please contact us