Assessing Nucleic Acid-based Therapeutics – Fully Integrated Laboratory Workflow for Regulated Bioanalysis

Assessing Nucleic Acid-based Therapeutics – Fully Integrated Laboratory Workflow for Regulated Bioanalysis

Abstract
TATAA Biocenter supports the biotech/pharma industries and academic researchers with molecular analysis and regulated bioanalysis since more than 20 years. Our customers rely on us to provide answers to complex biological challenges leveraging on knowledge in the fields of genomics, transcriptomics, and proteomics. Starting out as a training organization TATAA developed into a Contract Research Organization (CRO) offering standard as well as customized solutions based on the Polymerase Chain Reaction (PCR) and its more advanced versions: quantitative PCR (qPCR), digital PCR (dPCR), and Next generation sequencing (NGS).
With the emergence of cell and gene therapies new analytical tools and workflows are needed for clinical studies like biodistribution, pharmacodynamics and pharmacokinetics that rely on the characterization of nucleic acids. While classical drugs based on small organic molecules, peptides and proteins are analysed by relatively insensitive methods such as chromatography, NMR, and spectroscopy, the new drugs rely on precision nucleic acid analysis based on amplification, where a single molecule is a potential contaminant. This is TATAA’s specialty. TATAA has contributed to more than twenty industry (CEN & ISO) guidelines for molecular analyses as well as the MIQE and dMIQE guidelines for scientific publications. The service requires strict regulatory compliance according to Good Laboratory Practice (GLP), with emphasis on traceability and data integrity. Projects must be performed efficiently in high throughput, which relies on Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) optimized for the purpose.
Customized, cloud-based integrated LIMS and ELN systems provide the capability to capture and store data in a notebook, tracing the entire process from the arrival and storage of samples in freezers, to nucleic acid extraction, dilution, addition and tracking of reagents, instrument setups and communication, and the final recording of results.
Using custom templates, representing a virtual guide to our top modern purpose-built laboratory, allows tracking of all experimental steps and gives full control of the workflow, including historical access to all processes through an audit trail.