Our ddPCR & ELISA Services
- ddPCR Sample preparation
- Viral vector quantity
- Residual DNA quantity
- Host cell protein
- Viral particle quantity and integrity
DNA / RNA extraction protocol development and qualification
Extraction of nucleic acids is a challenging and one of the most crucial steps influencing reliable and accurate quantification of the target DNA/RNA in the sample. We develop custom DNA/RNA extraction protocols, optimise and evaluate. Finally, the protocol can be qualified and used in subsequent analyses.
Viral vector copy number quantification by digital PCR
Viral vector copy number determination digital PCR offers most accurate quantification. We develop new custom assays and/or optimise existing assays, evaluate their performance and qualify and/or validate best performing assays. Different platforms for digital PCR can be employed e.g., Bio-Rad’s ddPCR system, Quantstudio 3D, Fluidigm, Qiacuity).
Host cell DNA and plasmid DNA quantification
Residual cell line DNA and plasmid DNA in the final product raise safety concerns. Accurate and sensitive approaches are need to determine their presence and quantity. We develop new custom assays or use existing protocols for quantification of hcDNA and pDNA with qPCR or dPCR.
Host cell protein (HCP) ELISA based quantification
Proteins originating from cell line culture also present a big safety concern. We offer optimisation of the ELISA-based protocol for accurate quantification of proteins.
ELISA based quantification and electron microscopy
ELISA based viral particle quantification can be used to supplement molecular data on viral genome quantity, while negative staining electron microscopy offers unique opportunity to observe the viral particles and possible impurities - the latter assays are performed in collaboration with experts at National Institute of Biology (NIB).
NibaPlex®
The importance of multiplex dPCR assays for the quantification of complete genome populations in your AAV product
The importance of multiplex dPCR assays for the quantification of complete genome populations in your AAV product
Niba Labs is pioneering the development of multiplex dPCR assays and has been sharing and promoting the results of the innovative NibaPlex® analysis tool to the AAV community for the past several years.
We are excited about the results on the use of multiplex dPCR for the evaluation of vector genome integrity in a recent publication by Eisenhut et al.
The authors have shown an excellent correlation between the quantity of complete genomes (by multiplex dPCR) and biopotency results. Furthermore, they explained the differences in the biopotency results of two samples, in which different transfection protocols were used.
In addition, the commonly used simplex dPCR vector genome titer (targeting only a small region of the genome) did not explain the differences in biopotency between the samples tested.
These results highlight the importance of multiplex dPCR assays for the assessment of vector genome integrity and characterization of the AAV vector genome.
Our portfolio of NibaPlex® assays is designed for both the quantification of complete vector genomes and the distribution of incomplete populations.
The NibaPlex® results, especially the quantity of complete genomes as suggested in the mentioned publication, can be used as a direct indication of biopotency and could provide much better guidance in process development and optimization than the ratio of empty to full capsids or the classical simplex vector genome titer.
For more information on how NibaPlex® can help you achieve better yields of potent AAV vectors, please contact us by clicking the “Request Free Sample” button.
We are excited about the results on the use of multiplex dPCR for the evaluation of vector genome integrity in a recent publication by Eisenhut et al.
The authors have shown an excellent correlation between the quantity of complete genomes (by multiplex dPCR) and biopotency results. Furthermore, they explained the differences in the biopotency results of two samples, in which different transfection protocols were used.
In addition, the commonly used simplex dPCR vector genome titer (targeting only a small region of the genome) did not explain the differences in biopotency between the samples tested.
These results highlight the importance of multiplex dPCR assays for the assessment of vector genome integrity and characterization of the AAV vector genome.
Our portfolio of NibaPlex® assays is designed for both the quantification of complete vector genomes and the distribution of incomplete populations.
The NibaPlex® results, especially the quantity of complete genomes as suggested in the mentioned publication, can be used as a direct indication of biopotency and could provide much better guidance in process development and optimization than the ratio of empty to full capsids or the classical simplex vector genome titer.
For more information on how NibaPlex® can help you achieve better yields of potent AAV vectors, please contact us by clicking the “Request Free Sample” button.
Our recent collaboration with Niba has helped to progress our Genome Integrity platforms forward with dPCR technology. Working with Niba Labs Team has given us valuable insight and background into the mathematics of this cutting-edge analysis platform.
Niba is knowledgeable, passionate, and they worked diligently to develop and provide results promptly. Upon completion of their development, Niba took the time to walk us through their NibaPlex technology and ensured that we were confident in these new techniques and mathematics. We now view Niba as a reliable and long-term resource for collaboration and industry insight. Utilizing NibaPlex as a characterization assay of one of our programs has given us valuable insight to the quality of our products and we aim to continue exploring applications.
We have been working with Niba Labs for about three years, focusing on gene therapy analytical methods to support clinical programs. We have been impressed with their performance, especially their work relationship with us, analytical results, and assay performance documentation for our projects. They have provided outstanding customer service, updated us promptly on the progress of the projects and always met the agreed upon timelines. We continue to work with Niba Labs due to this past experience and our expectation that they provide innovative services for gene therapy within the agreed deadlines.
Our Services