Supporting modern biotherapeutics
Drug development today encompasses a broad range of therapeutic approaches. A monoclonal antibody, a viral vector, and an antibody-drug conjugate (ADC) are all biologic medicines, but they are fundamentally different in structure, mechanism, and behaviour in the body. In bioanalysis, the term modality refers to this class of molecule, the type of therapeutic being developed. Understanding the modality is not just a scientific classification exercise. It directly determines what needs to be measured, what assay format is appropriate, and what regulatory expectations apply.
A monoclonal antibody is a large, relatively stable protein that can be quantified with well-established immunoassay formats. An antibody-drug conjugate carries a cytotoxic payload attached to that antibody, creating a heterogeneous mixture of species that each behave differently in circulation. A viral vector introduces genetic material into cells and must be characterised for both physical particle count and functional potency. Each of these requires a different analytical strategy. Running the wrong assay or adapting an assay built for one modality without accounting for the structural differences of another generates data that misleads rather than informs. Modality-specific bioanalysis means designing the measurement strategy around the molecule, not the other way around.
Pharmacokinetics: the foundation of bioanalytical programmes
Across every modality, pharmacokinetic (PK) analysis is central to drug development. PK describes how a drug moves through the body, how it is absorbed, distributed, metabolised, and eliminated. Without reliable PK data, it is impossible to determine the appropriate dose, predict how the drug will behave across different patient populations, or understand why a candidate is failing in the clinic.
For large molecules such as antibodies and therapeutic proteins, PK assays typically measure total drug concentration in serum or plasma over time. The resulting concentration-time profiles define key parameters such as half-life, clearance, and area under the curve (AUC), which drive dosing decisions and regulatory submissions.
Gyrolab is well-suited to PK work across modalities for several reasons. The platform operates at nanoliter scale, requiring as little as 1–4 µL of sample per assay. In preclinical studies, where serial sampling from small animals is limited, and in early clinical phases, where patient samples are precious, this is a practical advantage that affects study design and animal welfare. Throughput is high - a single Gyrolab disc processes multiple samples in parallel, with minimal manual intervention between steps. Critically, precision and reproducibility are consistent across runs and across sites, which matters when PK data must be comparable across a multi-site study or transferred to a CRO. Gyrolab supports both fit-for-purpose assay qualification in early research and full method validation in regulated GLP and GCP environments, using the same platform throughout.
Immunogenicity and ADA
Any biologic drug has the potential to trigger an immune response in patients. The body may recognise the therapeutic protein as foreign and generate anti-drug antibodies (ADAs), which can neutralise the drug, alter its PK profile, or cause adverse reactions. Immunogenicity assessment is therefore a regulatory requirement for virtually all biologic programmes, from early clinical trials through to post-marketing surveillance.
ADA assays are technically demanding. They must detect low-abundance antibodies in a matrix that already contains high concentrations of the drug itself, requiring assay formats that can manage drug interference, typically bridging assays or acid dissociation steps. Gyrolab handles these formats well. The automated, closed microfluidic workflow reduces variability introduced by manual pipetting, and the platform's dynamic range supports the titration steps needed to characterise confirmed positive samples. Ready-to-use Gyrolab ADA kit reagents are available for common modalities, including human IgG-based therapeutics and preclinical species, reducing development time for standard immunogenicity programmes.
Impurity analysis and titer assays in bioprocess
For programmes moving into manufacturing, additional assay types become critical. Host cell protein (HCP) assays detect process-related impurities that must be cleared to acceptable levels before a biologic can enter clinical use. Titer assays quantify product concentration during bioprocess to guide process development decisions. Gyrolab is widely used for all of these applications. The combination of high throughput, low sample consumption, and reproducibility makes it practical for process development laboratories running large numbers of samples across multiple process conditions, as well as for in-process testing in GMP manufacturing environments.
Modalities we support
Each modality comes with its own analytical challenges. Gyrolab immunoassays help teams measure critical attributes such as potency, concentration, immunogenicity, and biomarkers across a range of biologic formats.
Explore how Gyrolab supports the following therapeutic modalities.
