Unchained Labs launched in February with a $25m (€22m) financing and four months on the firm has increased its biologics characterisation product range by buying Avia Biosystems.
Spokesperson Taegen Clary said the demand for stability testing services is growing as pipelines focus on biologics and the addition of Avia brings Unchained Labs the Isothermal Chemical Denaturation (ICD) system, a tool which helps formulation scientists predict what will happen to their protein drugs.
“Biologics and biosimilars are definitely on the rise. 30% of new drug approvals are biologics and the sales of these drugs continues to skyrocket,” Clary told us. “These molecules require a high level of characterization and the regulatory agencies continue to increase the bar on what information is required for approval.
“Stability is and always has been a big concern, so any new tools that provides a higher level of insight into protein stability are extremely useful and in high demand.”
The ICD system therefore aids drug developers early on in the discovery process to whether their protein will remain in the native state or if the protein will unfold and aggregate in the unfolded state.
“Unfolded state (denatured) aggregation is not easily managed and proliferates over time, meaning a protein in solution that starts to unfold and that begins to aggregate will eventually become highly aggregated. This completely ruins a protein therapeutic.”
Clary could not divulge financial details of the deal but did tell us the platform bolsters Unchained’s presence in biological testing supporting the firm’s other offering, the multiplex protein stability platform Unit which uses a combination of fluorescence and static light scattering to measure the temperature at which a protein is half unfolded, and the onset of aggregation.
“Formulation scientists find this dual analysis extremely valuable when measuring multiple unfolding events and how they are connected to the onset of aggregation,” Clary said.
“It has been reported that our platform has helped scientists correlate the second unfolding event or transition that occurs commonly with monoclonal antibodies to the onset of aggression, something they cannot see with any other tool.”
Furthermore, almost every major Pharma owns a UNit system, we were told.