NibaPlex® Genome Integrity Solution
NibaPlex is a digital dPCR assay platform offering ready-to-use multiplex assay for viral vector genome integrity quantification. Designed for precision, ease of use, and scalability, NibaPlex empowers scientists in the cell and gene therapy (CGT), to accurately characterize their products, thereby ensuring their safety and potency.
Watch how NibaPlex works
Explore the molecular mechanism of action behind NibaPlex multiplex assays and the insights they deliver in the video below.
Why Choose NibaPlex?
FIRST dPCR GENOME INTEGRITY SOLUTION
All-in-one assays simultaneously detecting four target genome regions.
CUSTOMIZED MULTIPLEX dPCR ASSAYS
Designed to target specific viral vector genome regions.
COMPREHENSIVE GENOME INSIGHTS
Precise absolute quantification of complete and incomplete genomes.
PRECISE & ACCURATE
Expertly designed and wet-lab qualified for peak performance.
RAPID TURNAROUND
Multiplex assays streamline workflows and reduce hands-on time.
PROCESS CHARACTERIZATION AND VALIDATION
Batch-to-batch comparability data for AAV populations.
Revolutionizing Genome Integrity Analysis in Cell and Gene Therapy
The NibaPlex platform includes first-of-its-kind multiplex dPCR assays capable of simultaneous detection of four target regions on the viral vector genome, setting a new standard in viral vector analytics. These all-in-one assays provide unmatched insight into complete and incomplete genome profiles, delivering quantitative data on genome integrity that correlates strongly with results of cell-based biopotency assays.
The multiplex NibaPlex assays are designed to target four key viral vector genome elements essential to the therapeutic efficacy of CGT products: the enhancer and promoter regions, the gene of interest (GOI), and the poly-A tail. This four-point detection approach enables precise identification of the presence or absence of each element, offering broader coverage of the vector genome compared to standard simplex dPCR assays. The result is a more accurate and reliable assessment of genome integrity, even in complex, heterogeneous viral vector populations.
Each combination of the four targeted genome elements produces 15 unique vector genome fragment profiles, all of which can be precisely detected and quantified with NibaPlex. This results in accurately determined titers and a comprehensive understanding of your CGT product quality.
“NibaPlex, a new standard in viral vector genome integrity quantification—multiplex, precise, and designed for the future of cell and gene therapy development.”
Designed for the Future of Cell and Gene Therapy
The NibaPlex platform is more than a product—it's a commitment to scientific excellence. Its comprehensive product portfolio and user-centric design reflect our mission to provide high-quality, innovative solutions that meet the growing demands of cell and gene therapy development and regulatory requirements.
Custom Designed NibaPlex Assays for Targeted Genome Integrity Analysis
At NibaLabs, we prioritize the safety and potency of CGT products by enabling robust genome integrity analysis across all viral vectors. To support this goal, NibaPlex assays can be tailored to your specific vector genome elements upon request, ensuring precise, fit-for-purpose results that align with your development needs. Please contact our team to explore how our custom-designed solutions can advance your CGT workflows.