PARTNERING SOLUTIONS
Partnering Opportunities
We are proud of and committed to our collaborative efforts with biopharma partners, clinical leaders and researchers, laboratorians, regulators and other healthcare partners—and of course, patients. As we aggressively take on the most effective and informative ways to measure and monitor immune system activity and help our current and future partners advance important work on immune-related conditions, we offer the following custom product development, clinical trials and research-related partnering solutions.
Biopharma Partnering
Custom Assay / Panel Development & Manufacturing
Clinical R&D
Clinical Trials Testing / Support (All Phases)
Study Design / Biospecimen / Workflows
Data Analysis & Interpretation
Regulatory & Commercial Strategy (Including CDx)
Clinical Research Collaborations
Clinical Studies
Biomarker Evaluation / Validation
Study Design / Biospecimen / Workflows
Data Analysis & Interpretation
Grant & Contract Proposals
With the advent of more sophisticated drugs and cellular therapies, our systems and insights will help more precisely determine who is likely to benefit and who may be at risk.
Biopharma Partnering
Clinical Trial Support
Because complement activation, cytokine/chemokine release, and other immune processes are unstable in vitro and susceptible to artificial activation by numerous preanalytical factors, multi-site bioanalytical services require a different approach. Distributing a decentralized and integrated sample management/test system across sites is the best way to standardize immune activation testing. Kypha’s systems are deployed to deliver reliable blinded exploratory biomarker analysis or immediate unblinded results for rapid patient screening.
Custom Development and Manufacturing
Kypha’s development program is informed by years of experience studying workflows in diverse clinical settings from emergency rooms to ICUs. Our in-house assay development and manufacturing team is available for custom assay development and deployment to support your program’s bioanalytical, safety monitoring, and companion diagnostic requirements. All projects are performed under ISO 13485, GMP and CLSI guidelines for in vitro diagnostic tests.
Contact us to see how partnering with the Kypha team can improve your strategy
Despite decades of research on the complement system, much of its clinical potential remains unfulfilled. But we’re working every day to help actualize the diagnostic potential of that system and make meaningful, clinically relevant advances.
Clinical Research Collaborations
We have extensive experience with and optimized multiple clinical workflows to overcome the pre-analytical challenges that have long hindered precise immune monitoring. This experience is enabling comprehensive immune monitoring with dramatically increased frequency to provide better insights into disease processes and treatment effects.
We’re proud of our ongoing and impressive collaborative efforts with major medical centers, supporting clinical research studies in diverse immune-mediated conditions and establishing true reference ranges for healthy individuals. In addition, these relationships and the resulting data are facilitating a better understanding of clinical algorithms, reimbursement, pricing, politics and healthcare economics.
We continue to offer consultative, analytic, and operational support for on-site or centralized laboratory monitoring of immune system activation. For more information on how we can help and support you, please contact us directly.
Contact us to see how partnering with the Kypha team can improve your clinical studies