The Solentim platform provides streamlined workflows for the creation, isolation and characterisation of high value cells. For over a decade, the Solentim platform has enabled workflows, validated through Regulatory submission, in key areas including gene therapy. Solentim’s unrivalled VIPS and Cell Metric instruments work to provide high efficiency single cell seeding and to capture evidence and provide assurance of clonality.
Gator Bio’s rapid assays and reusable probes offer a cost effective and efficient solution for AAV titre and analytics testing. Based on Gator Bio’s next generation BLI technology, their bioanalytical tools for AAV characterisation are rapid, flexible, sensitive and robust. Gator Bio’s AAV kits are accurate and precise, with a wide dynamic range to cater for samples across the AAV production workflow.
Halo Labs BMI technology measures subvisible particles, a quality metric that predicts stability to minimise risk and enable more informed decisions about viral vector formulations and quality assessment. Halo Labs Aura GT systems allows high-throughput subvisible imaging, counting and size distribution, and fluorescence applications ID capsids, aggregates and track DNA leakage to determine viral vector stability.
Clonality and improved outgrowth
of HEK 293 cell lines for GT
Assurance of clonality; a key regulatory requirement
Adeno Associated Viruses (AAV) are one of the prime modalities to deliver genes of interest for treatment. Detailed characterisation AAV capsids is critical for high efficacy and safety. Gator Bio’s rapid assays and reusable probes offer a cost effective and efficient AAV analytical method.
Gator Bio has developed solutions to monitor AAV critical quality attributes, offering a selection of assays for:
Based on Gator Bio’s next generation biolayer interferometry (BLI) technology, their bioanalytical tools for AAV characterisation are rapid, flexible, sensitive and robust. Being fluidics free, Gator BLI accurately measures crude samples and matrices used in viral vector process development and manufacturing. Gator Bio’s AAV assay kits are accurate and precise, with a wide dynamic range to cater for samples across the vector production workflow.
Comparing BLI and ELISA for AAV quantitation
High sensitivity quantitation of AAV titre
AAV empty / full ratio determination
As parenterally administered drugs, gene therapies must undergo the same rigorous safety testing required by the FDA for protein therapeutics. This includes characterising the stability of the vector by monitoring the formation of subvisible particles that can also lead to adverse immunogenic events.
Subvisible particle measurements are a stability predictor that minimises risk and enables more informed decisions about viral vector formulations and quality assessment. Backgrounded Membrane Imaging (BMI) on the Aura GT system detects how parameters like freeze-thaw cycles, ionic strength, and different additives influence vector stability to determine optimal formulation and storage conditions for your gene therapy product.
Additionally, compromised capsid integrity can result in DNA leakage which promotes aggregate formation, potentially lowering product purity and significantly reduce drug efficacy. Understanding how capsid proteins interact with leaked DNA payloads is essential to avoid vector aggregation and ensure high quality drug product development, control, and shelf-life.
Aura GT’s BMI technology allows high-throughput subvisible imaging, counting and size distribution, and fluorescence applications ID capsids, aggregates and track DNA leakage to determine viral vector stability.
PLC 2050 and PLC 2250 Purification Systems with Autosampler are configured with a GX-241 Liquid Handler and VERITY 4020 Single Syringe Pump for automated sample injections for increased throughput. These systems allow you to queue samples and create multiple, unattended runs.
PLC Purification Systems contain a variable dynamic mixing chamber and feature two or four independent solvent inlets for binary or quaternary gradients.
PLC Purification Systems include a conductivity / pH monitor and four-wavelength UV/VIS detection, with an optional upgrade to a diode array detector (DAD) or evaporative light scattering detection (ELSD).
PLC Purification Systems have a large fraction capacity, containing a three-rack fraction collector with unlimited collection cycles. These systems support purification from 10 – 100 mm HPLC columns, 100 – 1000 mL CPC columns and 2.5 g – 1.2 Kg flash cartridges.
PLC Purification Systems feature a dual reciprocating pump technology, with a built-in automatic injection valve.
