LIMS and GLP – the benefits to our customers

TATAA Biocenter has been working hard over the last 12 months implementing a new LIMS (Laboratory Information Management System) for their new state-of-the-art laboratory in Gothenburg. We talk with Jens Björkman, TATAA’s Chief Operating Officer, about the needs for a LIMS, GLP compliance and how these will benefit TATAA’s customers.

Hi Jens, give us some background to why TATAA Biocenter wanted to invest in a LIMS

TATAA Biocenter is growing, and increasingly working with new industry clients. As a result, we needed to invest in our processes to increase the efficiency of our laboratory and projects.

We needed to connect all our instruments, data and projects – keep them under one roof. We wanted to track our projects rather than the individual samples. With a LIMS you can now follow projects from start to finish – including all the samples in that project, and all the data regarding qPCR, dPCR and extraction methods – everything involved in the project.

We also wanted to remove all the manual data interventions within a project, all the paperwork, make the data security much tighter and more controlled to decrease the risk of human error. Take away the need for handling large data in Excel files, where the push of a wrong button can lead to errors.

Did you have difficulties with managing data beforehand?
Not difficulties but challenges. We had many SOPs (Standard Operating Procedures) to ensure the data was intact and uncorrupted, but this was complex and time-consuming. Now we can interpret the raw data much better, which saves a lot of time, and again, you get higher security and traceability.

We needed full data traceability to become GLP (Good Laboratory Practice) compliant. This was a key reason we chose Benchling LIMS, it allows you to log everything, full traceability of all the steps in a project and the lifecycle of a sample.

We will be the first CRO fully dedicated to molecular analysis for cell and gene therapy with LIMS

Jens Björkman, COO

Has this been a difficult implementation process?
It has taken approximately 12 months to implement, and it has been totally unique. We are working with RNA and advanced therapeutics, using dPCR and qPCR, and to my knowledge there is no “out of the box” solution from any LIMS providers.

It’s one thing to just capture qPCR data and then store it in a notebook, everyone is doing that but tracing the sample through the entire process – from the sample being put in freezers, to extraction, dilution, and inclusion to master mixes for qPCR or dPCR – is unique.

We have 30 customized templates or workflows, a virtual guide to the lab, predefining what we are going to do in the experiment – when we add a plate, when the input file for an instrument ran, the processing of data. All these steps are logged in an audit trail, and we can see when every step was taken.

Has this been a difficult implementation process?

Our LIMS will give customers more confidence in their data as we drastically reduce the risk of human error. We will handle the data more efficiently, transferring it in an intact way, so we can spend more time on processing and analysing the data. We can offer an end-to-end solution with traceability with very high-quality and full integrity of the data.

The customer will also get a more standardized output of data, raw instrument data, QC data, concentrations, how intact the mRNAs, and the transcripts. And for us, it is easier to extract and manage the data from all our instruments.

Will this help with the delivery of the project?
I think we will be able to work faster, increase the speed of delivery. Our customized templates take out a lot of the manual work, data entry for example. We will not only be tracking samples, but we’ll also be tracking reagents – how much reagent is left, where they are. You be able to see the needs of the project live, so again, less manual work.

The whole process also gives us is a very tight layer of security and data protection. I can’t emphasize enough how important it is and how beneficial it is to have all our data hosted in the LIMS cloud, a European cloud that is very well protected and fulfils all the requirements for GLP and is GDPR compliant – respectively important for pre-clinical studies and patient confidentiality, pivotal for meeting GCP (Good Clinical Practices) requirements, which we will also reach in 2023.

This all sounds very promising for the future of TATAA Biocenter
It really is. There are three main drug modalities: small molecules, (chemically synthetised drugs), protein-based drugs (such as monoclonal antibodies) and the third modality, nucleic acid-based drugs, cell and gene therapy, and this is the future of drug development.

It is these nucleic-acid encoding proteins, that drug developers aim at administering to modify cells to produce certain proteins with therapeutic effects. This development relies heavily on precision nucleic acid analysis, and this is what we specialise in – we have a very robust knowledge of dPCR, qPCR and other molecular tools for analysing these nucleic acids.

For other CROs [Contract Research Organizations] performing GLP-compliant bioanalytical analysis, such as mass spectrometry or ligand-binding assays, the transition to advanced PCR, to a technical level we are at, will take a lot of time, work and experienced personnel – you can’t do it overnight. We have over 20 years of experience in the molecular analysis field, and we are therefore uniquely positioned to efficiently support this new drug modality.

With GLP compliance early next year, we will be the first CRO fully dedicated to molecular analysis for cell and gene therapy – capable of supporting the entire drug development pipeline with a LIMS covering the whole sample lifecycle for PCR analysis.

If you would like more information about TATAA Biocenter please contact us