Niba Labs offers custom dPCR assay development, validation and sample testing focused on quantification and detection of vector genomes and impurities (DNA, protein). We are qualified to analyse AAVs, LVVs, AVs and SV40s ÔÇô most widely used virus vectors for delivery of therapeutic genes to target cells and tissues.
Our experienced analytical development team works with customers through all stages of development, qualification, and validation of the assays with most recent addition of GMP testing.

Niba Labs mission is to provide customers with high quality results and attractive turnaround time whilst addressing and solving new challenges. Furthermore, we offer scientific support throughout the whole process development phase.
Multiplex assay platform for genome integrity evaluation
Key benefits of our advanced multiplex approach

  1. Process optimisation that leads to higher yield of full-length viral genomes in the capsids
  2. Better characterised product
  3. Lower production costs per dose
  4. Improved process management & control
  5. Improved safety attributes for the patient
  6. Fully customised for your vector genome (upon request)
The presence of a complete vector genome and the absence of impurities play a critical role in assessing the purity, efficacy and safety of gene therapies. Niba Labs experts have addressed the issue of AAV vector genome integrity by developing an advanced dPCR multiplex approach. NibaPlex® multiplex assay is an upgrade of the simplex vector genome titer assay and provides accurate quantitative genome integrity results.

The result of our development efforts is NibaPlex® 4-plex dPCR assay mix, designed to quantify viral vector integrity and assess the presence of different fragment populations. NibaPlex® 4-plex assay provides greater insight into the percentage of full-length genomes and other fragment populations.

The use of such an assay can better guide process development to produce AAV products with higher yields of complete, full-length vector genomes.

In addition, Niba Labs offers custom development of multiplex assays for different platforms (dPCR, ddPCR) to assess the integrity of viral vector genomes and nucleic sequences for all other applications.
dPCR Assay development & validation
Viral vector copy number is determined by molecular methods, with digital PCR (dPCR) providing the most accurate quantification. One of the most important steps besides sample preparation is the development of an appropriate assay and its qualification and/or validation. Depending on the target sequence and structure, multiple assays may be required for reliable quantification. Niba Labs can develop new custom assays and/or optimize existing assays (e.g., qPCR assays for use in dPCR), evaluate their performance, and qualify and/or validate the best assays. Niba Labs currently has Bio-RadÔÇÖs ddPCR system, and QiagenÔÇÖs ndPCR system, but also has experience working with other digital PCR systems.

Niba Labs has experience with AAVs, LVs, AVs and SV40s vector platforms.
dPCR Comparability and bridging studies
Niba Labs works with two of the most widely used dPCR platforms (Bio-RadÔÇÖs droplet digital PCR system and QiagenÔÇÖs nanoplate-based dPCR).

With access to and experience with other dPCR platforms, Niba Labs can perform any type of comparability study between different platforms or between dPCR and qPCR methods. If you are thinking about switching between platforms, Niba Labs can also offer a range of bridging studies to test and optimise current assays for the second platform even before new equipment is installed in your laboratories.
Niba Labs also offers other, non-dPCR-based techniques for viral vector characterisation. These methods focus mainly on the identification and quantification of vector capsids and impurities. .

DNA impurities in the final product, such as host cell line DNA (hcDNA) and plasmid DNA (pDNA) are one of the most important safety concerns. In addition to different sample preparation methods, different approaches can be used to quantify hcDNA and pDNA.

Niba Labs offers development of new custom assays (e.g., customer specific pDNA) or use of existing protocols for quantification of hcDNA and pDNA with qPCR or dPCR.

Process related impurities such as host cell proteins (HCP) can also be a major safety concern. Currently, ELISA-based quantification is the most widely used and allows easy quantification of the HCP in various samples. Niba Labs offers ELISA-based quantification of HCP.
High-throughput sequencing can identify all nucleic acids present in the sample. By selecting the type of pre-treatment Niba Labs can identify their origin (e.g. encapsidated or non-encapsidated nucleic acids). We can confirm the uniformity of the vectorÔÇÖs genome sequence or detect and determine the frequency of any mutations that may be present. By mapping to the reference sequences, Niba Labs experts can determine the amount of impurities and identify their origin.

In addition, Niba Labs can perform metagenomics analysis on unmapped sequences or even in-depth analysis of chimeric sequences that may be present in samples. Niba Labs offers the entire workflow from sample preparation to data analysis for both short-read and long-read sequencing.
When deeper insight into final sample quality is required on the level of viral particles, they can be quantified and observed to determine the presence of abnormalities. ELISA-based quantification is a simple and rapid system for quantifying the assembled viral particles, while transmission electron microscopy (TEM) with negative staining offers unique ability to observe the particles themselves. Niba Labs offers ELISA-based quantification of viral particles and TEM evaluation of full/empty ratio, particle integrity, and identification of possible sub visible impurities.
Niba Labs has expanded its services to include GMP method validation and analytical testing. The goal is to seamlessly support our partners in process development, clinical supply and market launch of their gene therapy drugs.
Our activities can support process development at different stages
  • Sample analysis in support to pre-clinical and clinical studies in accordance with international testing guidelines and regulations,
  • support in short-term and long-term stability studies,
  • down-stream process optimization support.
We operate under Biosafety level 2 conditions and according to SIST EN ISO/IEC 17025:2017.
We are equipped with state-of-the-art equipment. In addition, our close connection with NIB and Life Science Park Mengeš allows us to use state-of-the-art institutional infrastructure. All devices and laboratory equipment are controlled and maintained in line with the requirements above.
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