Multiple analytical platforms from Creative Biolabs are elaborately integrated for providing customers a comprehensive ADC stability profile which contains the data of pH stability, thermal stability, aggregation aspects and in vitro/in vivo plasma stability.
ADCs offer unrivaled potential for targeted cancer treatment by combining with the best features of both tumor-selective monoclonal antibodies and potent small-molecule cytotoxic drugs through a conditionally labile linker that is stable within systemic circulation but cleaved within the target cells, to create a single moiety that is highly specific to numerous cancer cells. Since ADC is designed to deliver highly potent cytotoxic drugs predominantly to the disease tissue with minimum drug release in circulation, the stability of this molecule, especially the stability of the drug-antibody connection in the plasma, has profound impact on its safety and therapeutic efficacy. Creative Biolabs provides a full range of services to completely analyze the stability of your ADCs. The pH stability assessment serves to help customers identify the pH of maximal stability. Experts from Creative Biolabs utilize Differential Scanning Calorimetry (DSC) to measure the melting temperatures(Tm) and heat capacities to monitor the thermal stability of your ADCs, while aggregation aspects of ADCs can be measured by Dynamic Light Scattering (DLS). To assess the in vitro plasma stability, ADCs are incubated in plasma (selection of appropriate plasma depends on the properties of the ADC) at 37 °C for a certain time and the drug loss is monitored by affinity capture LC-MS. Other analytical techniques are also available upon request. In vivo plasma stability is also included in our ADC stability analytical strategy. Scientists from Creative Biolabs will design an appropriate animal model which will be treated with your ADC for a certain time to collect blood samples and the in vivo stability can be measured by quantifying the total antibody and ADC concentrations in the plasma.
By leveraging advanced instruments and extensive expertise, Creative Biolabs has come to the unique position not only have the technology and experience necessary for the comprehensive assessment of your ADC, but also the capability to provide these analytical services in the most cost and time efficient manner.