An exploratory study of the durability of biopharmaceuticals in AstraZeneca's Quality Control Operations

Sammanfattning

This master's thesis has been performed at the Quality Control department (QC) at Sweden Biomanufacturing Center (SBC), AstraZeneca. The main goal of the master's thesis was to examine if a monoclonal antibody-based (mAb) drug product (DP) at the QC laboratory is still representative of the batch after storage up to one month after opening, since today's practice states a longevity of 24h after opening. The purpose also includes investigating how the antibody is affected by different storage conditions. This could possibly lead to an extension of the durability, which would enable optimizing the usage of the biopharmaceuticals in QC operations, reducing waste and increasing the availability of DP. The stability of biopharmaceuticals is monitored to ensure safe and highly effective drugs to patients. To investigate how the stability is affected by opening of the samples and different storage's, the stability of the biopharmaceutical has been evaluated by three methods: capillary electrophoresis (CE), high-performance size exclusion chromatography (HPSEC) and capillary isoelectric focusing (ciEF). These methods were performed each week during a month to monitor the progression of impurities e.g. aggregates and fragments in the DP. Results showed a slight decrease in purity for all samples. Samples in non-recommended storage condition showed a more progressed degradation than samples in recommended storage conditions. However, all samples stored in recommended storage condition passed the specifications and control limits set by AstraZeneca at all time points. Therefore, AstraZeneca is recommended to extend the durability of the DP, to two weeks after opening.