Niba Labs develops quantitative digital PCR assays for nucleic acid constructs, including viral vector genome quantification. They also create custom multiplex approaches to investigate sequence integrity, advancing analytical methods for genome integrity evaluations.
Funding
Funding not disclosed
Founders
Product
Problem
The development and manufacturing of cell and gene therapies require precise and reliable analytical methods to ensure the safety, purity, and efficacy of viral vectors. Traditional methods for quantifying viral vector genomes and detecting impurities often lack the sensitivity and multiplexing capabilities needed for comprehensive characterization. This can lead to inaccurate assessments of vector integrity and potential safety risks.
Solution
Niba Labs provides advanced analytical services and assays for cell and gene therapy development, focusing on viral vector characterization. Their core offering includes custom digital PCR (dPCR) assay development, validation, and sample testing for quantifying vector genomes and detecting impurities such as host cell DNA, host cell proteins, and plasmid DNA. Niba Labs' proprietary NibaPlex® platform enables high-resolution multiplex dPCR, allowing for detailed evaluation of vector genome integrity and expedited custom assay development. They also offer comparability and bridging studies between different dPCR platforms, as well as other viral vector characterization activities like Next-Generation Sequencing (NGS) and Transmission Electron Microscopy (TEM).
Target Audience
Niba Labs serves biopharmaceutical companies, particularly those involved in cell and gene therapy development, clinical research, and manufacturing, who require precise and reliable analytical methods for viral vector characterization.
Features
- Custom dPCR assay development and validation for AAVs, LVVs, and AVs
- NibaPlex® platform for multiplex dPCR, enabling simultaneous detection of multiple target regions on the viral vector genome
- GMP method validation and analytical testing to support process development, clinical supply, and market launch
- dPCR comparability and bridging studies between different platforms (Bio-Rad's ddPCR system and Qiagen's nanoplate-based dPCR)
- Quantification of DNA impurities (hcDNA, pDNA) using qPCR or dPCR
- ELISA-based quantification of host cell proteins (HCP)
- NGS services for identifying and quantifying nucleic acids, detecting mutations, and performing metagenomics analysis
- TEM evaluation of viral particles for full/empty ratio, particle integrity, and identification of sub-visible impurities