Why does automating immunoassays change your timeline?

Answer first: because the slow part of an immunoassay is rarely the chemistry — it is the pipetting, the dilutions, the incubations, and the reruns. Gyrolab runs the assay inside a disc with nanoliter-scale microstructures, instead of a microtiter plate. The instrument automates liquid handling and detection, and short flow-through times replace long plate incubations. You start the run and come back to data.

How does automation reduce variability in immunoassays?

Fewer manual steps mean less variability. When Gyrolab® automates liquid handling, your assay precision depends far less on each analyst's pipetting technique.

At VIVEbiotech, a p24 assay used to quantify lentiviral vectors moved from a manual ELISA to Gyrolab. Total assay time fell from more than 6 hours, about 4 of them hands-on, to under 2.5 hours. Precision improved from up to 20% CV to below 10% CV, with recovery of around 99%. 

Why are Gyrolab assays easier to transfer between labs?

An automated assay is easier to transfer because there is less manual technique to hand over. Gyrolab® performs each step the same way in every lab, so your method behaves more consistently at the receiving site.

Panelists in a Cell and Gene Therapy Insights discussion made the same point. Absolute response values can differ slightly between instruments, but the standard curves, and the concentrations you calculate from them, stay consistent.

How much throughput can you plan for with Gyrolab?

Gyrolab gives you throughput you can plan around. As a rule of thumb, the single-disc Gyrolab xPlore system handles about 6 discs a day, roughly 570 datapoints. The five-disc Gyrolab xPand system handles about 10 discs a day, up to 960 datapoints, depending on how you schedule your runs.

Runs are unattended, so you can load the instrument in the evening and collect your data in the morning.

All microstructures on a disc are processed in parallel. That avoids the edge effects and time-dependent drift that can affect plate-based assays

Why use an open platform with ready-to-use kits for bioprocess testing? 

An open platform with ready-to-use kits lets you run both trending assays and targeted assays on one system. Trending assays show how your process performs over time, and targeted assays confirm that your critical quality attributes (CQAs) are met.

Ready-to-use Gyrolab® kits for HCP, AAV and Lentiviral capsid titer, endonuclease and other process-related impurities let you start trending without developing an assay first. When a CQA calls for a product-specific target, you can run in-house assays with your own antibodies.

Both run with the same automation and software, so your data stays consistent. Methods can also move from non-GMP trending to GMP testing without changing platforms.

Viral titer testing: can you measure AAV capsid and lentiviral titers reliably—including in crude lysate?

Answer first: yes. Gyrolab quantifies AAV capsid titer across serotypes using ready-to-use kits, and because the affinity column separates the capsid from the matrix, it supports quantification in non-diluted, complex material such as clarified crude lysate. Depending on the disc and titer range, the assay has covered about 10⁸ to 10¹².

What you can measure

• AAV capsid titer across serotypes with the Gyrolab AAVX Titer Kit, with a dedicated kit for AAV9. Together they cover the serotype range.
• Lentiviral p24, a key lentivirus marker, with a ready-to-use kit.
• Your own assay, if you prefer. The platform is open: use reagents from Gyros Protein Technologies, your own, those from your existing ELISA kits, or a combination.

Impurity testing: kits, or your own assay?

Answer first: both work, and it rarely has to be either/or. Start with a kit if one exists — supply and control are simpler, and validation groups tend to be more confident in a widely used kit. Develop a custom assay when you need lower quantitation, cell-line-specific coverage, or independence from a single supplier.

Why impurity data carries weight

Residual host cell proteins, nuclease, resin ligand traces and other process-related contaminants can drive immunogenicity, contribute to toxicity, and affect product stability. Keeping them in check is a core part of showing that a drug product is safe — and you often have to measure all of it from very little material.

In-house and custom HCP assays

When does building your own HCP assay pay off? When cost per sample, supply risk, or sensitivity are limiting you — and when you want the deep method understanding that helps during out-of-specification investigations.

The analytical development team at a gene therapy biopharma retired a commercial HCP kit for exactly those reasons: roughly $800 per plate, and the exposure of depending on a single vendor for a regulated assay. They produced their own antigen from a null cell line, confirmed it was representative on 2D gels, and had a polyclonal antibody raised against it — reaching 75–82% coverage of the custom antigen.

They then ran the same custom reagents on two platforms, and kept both:

Run on the same samples, both assays gave comparable results and showed the same HCP clearance from harvest to drug substance—the sign that the reagents, not the format, were doing the work. And because antibody production was the long pole at close to nine months, the honest planning lesson is that the reagents are the project, not the assay.

If a kit is close but not quite right, there is a middle path. Our custom assay service has built kits around proprietary or commercial reagents since 2021, quality-controlled for consistent performance and supplied as complete kits or individual reagents. One customer with high lot-to-lot variability in a commercial HCP ELISA sourced their own antibodies; our team labeled them and developed an optimized Gyrolab protocol. Custom assays also cover cell-line-specific HCP, AAV capsid, and ligand leakage assays.