Therapeutic proteins

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Therapeutic proteins

Automated immunoassays for therapeutic protein development

Therapeutic proteins, including monoclonal antibodies (mAbs), hormones, cytokines, enzyme replacement therapies, and coagulation factors, require rigorous bioanalytical support throughout development and manufacturing. From early cell line selection through clinical trials to batch release, teams need reliable data on drug concentration, immunogenicity, and process-related impurities. Each of these measurements places different demands on assay sensitivity, dynamic range, and matrix tolerance. Gyrolab automated immunoassays support PK, immunogenicity, and impurity testing across therapeutic protein programmes, delivering consistent, reproducible results from nanoliter sample volumes, from early discovery through regulated bioanalysis.

Cell line development

Select high-performing clones based on productivity and impurity profiles. A wide dynamic range and high throughput allow you to screen more candidates with fewer assay adjustments.

Purification and processing

Detect host cell proteins (HCP), nucleic acids, and chromatography contaminants such as Protein A across varying sample types. High matrix tolerance helps maintain data quality even in complex samples.

Quality control

Monitor impurities and confirm product consistency in manufactured batches. Automated workflows support reproducible results aligned with regulatory expectations.

For therapeutic proteins, PK assays typically measure total drug concentration using a capture-and-detect immunoassay format, most commonly with an anti-target or anti-idiotype reagent for capture and a species- or isotype-specific detection antibody. The assay must be sensitive enough to quantify drug concentrations at the tail of the concentration-time curve, where levels may be very low, while also handling the high concentrations seen shortly after dosing, often a range spanning three to four orders of magnitude.
Gyrolab is well-suited to PK work across the full concentration range. The platform's wide dynamic range reduces the number of dilution steps needed to bring samples into the assay window, which is a practical advantage when processing large numbers of samples from multi-timepoint PK studies. Automated sample handling eliminates much of the manual pipetting that introduces variability in plate-based PK assays, and the nanoliter-scale format means as little as 1–4 µL of sample is consumed per measurement - relevant in preclinical studies where serial sampling from rodents or other small animals is volume-limited, and in early clinical phases where patient sample availability is restricted.
For programmes requiring toxicokinetic (TK) analysis alongside PK, standard in GLP-regulated preclinical safety studies, Gyrolab supports the throughput and reproducibility requirements that regulated studies demand. The same assay platform used in research can be transferred and validated for GLP use without a change in instrumentation, reducing the method transfer burden as programmes advance