News / Décembre 2024 - Clean Mails - Next-Generation Sequencing
NEW: Clean Cells expands its cGMP identity tests by integrating NGS !
Clean Cells, already known for its wide range of tests, continues to expand its offer by integrating Illumina® technology into its services, enabling high-throughput sequencing for identity purpose.
NGS: a revolution in genetic sequence analysis
Next-Generation Sequencing (NGS) is a revolutionary technology that enables DNA and RNA sequences to be decoded rapidly and with great precision.
NGS offers the possibility of sequencing millions to billions of nucleic acid fragments in parallel, reducing analysis time and cost while increasing the amount of data generated.
The ability to characterise mutations at genome or exome level is key to accelerate the research, development and production of innovative treatments. That’s why NGS plays a central role in the discovery of new drugs and the analysis of biomarkers in the biotechnology and pharmaceutical research sectors.
Clean Cells, your reliable partner for Identity test under GMP & non-GMP grade
Clean Cells is delighted to add NGS to its identity test panel! Available for your plasmids, viruses, bacteria, vectors and vaccines (RNA & DNA), we can now support you for Next-Generation Sequencing identity test under GMP and non-GMP grade.
Our offer is divided into several steps:
- Nucleic Acid Extraction
- Library construction
- Sequencing
- Bioinformatic analysis
This assay is fully validated according to ICHQ2 guidelines.
Our routine testing Turn Around Time are 3 weeks for assays in non GMP conditions & 4 weeks in GMP conditions.
Our track record has already enabled us to support our partners in the identification of their research projects, as well as in the release of clinical batches of vaccines and viral vectors.
The implementation of this new technology for identity purposes is a step in the proposal of innovative solutions that will be complemented in the future by a viral safety panel using NGS.
Expert team & High-quality deliverables
At the end of these various steps, our expert and qualified teams will be able to provide you with reports including:
- Consensus sequence,
- Coverage percentage relative to a reference sequence,
- Sequencing depth,
- Variant detection (SNP, INDEL).
We attach great importance to the interpretation of data and the clear communication of results to our partner.
This data will enable you to meet the requirements of Eur.Ph 5.14 and ICHQ5B regulations.
In any biological-based project, particularly in industrial or regulated contexts such as drug development or clinical trials, additional quality control is a crucial step in guaranteeing the quality of your materials.
Clean Cells has been specialising in the quality control of biological materials for over 20 years and can also support you for Biosafety testing, Purity, Potency & Cytotoxicity assays.