Experts in Potency Assays

Binding and Cell Based Potency Assays

The potency of a therapeutic biologic is most commonly determined using a cell based bioassay and is frequently supported by a complimentary binding assay that is based upon the primary mechanism of action (MOA) of the therapeutic. Such methods play a critical role at all stages of product development and are essential tools that are employed during clone selection, process development and optimisation and will ultimately feature as the most critical of the lot release assays.

The importance of getting the method correct cannot be overstated and considerably attention should be applied during development to ensuring that robust methods are built in line with best practices, provide consistent, accurate and precise results over time and are stability indicating. With a comprehensive knowledge of the bioassay requirements across clinical phases and therapeutics classes, Antibody Analytics offers a range of best-in-class binding and cell based assays to characterise biosimilars using QuBas Bioassay Software and can apply our expertise to develop high quality potency methods for novel therapeutics.

Custom Assay Development Services

With a with range of technology platforms and access to continuous/immortalised cell lines as well as primary cells, Antibody Analytics can develop custom binding assays and cell based potency assays across a variety of formats to evaluate a diverse range of mechanisms of action.

For more details on our approaches to bioassay development or to discuss a project, please click here to contact us

Biosimilar Assays

The Antibody Analytics management team have been providing biosimilar characterisation services for over 5 years working across a wide variety of assay formats and molecules and offer characterisation services based upon the following biosimilar molecules/methods:

Adalimumab (Humira): TNF-alpha binding and cell based TNF-alpha neutralisation bioassays
Bevacizumab (Avastin): VEGF binding and cell based VEGF neutralisation bioassays
Denosumab (Prolia): RANKL binding and cell based RANKL neutralisation bioassays
Etanercept (Enbrel): TNF-alpha binding and cell based TNF-alpha neutralisation bioassays
Golimumab (Simponi): TNF-alpha binding and cell based TNF-alpha neutralisation bioassays
Infliximab (Remicade): TNF-alpha binding and cell based TNF-alpha neutralisation bioassays
Tocilizumab (Actemra): IL-6R binding and cell based IL-6 neutralisation bioassays
Ustekinumab (Stelara): IL-12 binding and cell based IL-12 neutralisation bioassay

For more details on specific methodologies or to discuss a project, please click here to contact us