Trastuzumab is a monoclonal antibody treatment for breast and stomach cancers that are human epidermal growth factor receptor 2 (HER2) positive. It is sold under the brand name Herceptin by originator company Genentech/Roche, but a range of biosimilar versions are also available. Amgen has developed a biosimilar version (ABP 980) which is sold under the brand name Kanjinti and was approved by the European Medicines Agency (EMA) in 2018.

Like many monoclonal antibody treatments, ABP 980 (Kanjinti) is supplied as a powder for concentration for solution for infusion and must be reconstituted with sterile water prior to dilution in IV bags.

Antibodies are complex molecules and may be exposed to factors that cause degradation during preparation, transport, and storage. It is important that the product does not degrade during storage and finding ways to extend the shelf life of the product, such that it can be stored for longer periods without loss of quality, improve efficiency by allowing advanced batch preparation, dose banding strategies and vial sharing. Cost savings can also be made by reducing drug waste.

In a study recently published in GaBI Journal [1], researchers report that ABP 980 (Kanjinti) remains stable for extended periods in multi-dose bags and elastomeric devices.

The study investigated the effects on the quality and stability of ABP 980 (Kanjinti) when stored in concentrated multi-dose bags and following dilution and extended storage in IV bags and elastomeric devices.

The researchers used a range of techniques to assess stability, including measures of appearance and pH as well as size-exclusion chromatography (SEC), non-reducing and reducing capillary gel electrophoresis (CGE), capillary zone electrophoresis (CZE), sub-visible particle counting and cell-based proliferation inhibition assays.

They found that, whatever the concentration, container or storage duration, there were no significant differences to measures of stability.

As a result, they conclude that ABP 980 (Kanjinti) remains stable when prepared using controlled and validated aseptic processes, stored protected from light for extended periods at 2°C–8°C, and subjected to in-use temperatures.

This means ABP 980 (Kanjinti) can be prepared in advanced and stored at 2°C–8°C until required, which reduces costs and saves clinical time. The fact that it is also stable in portable elastomeric devices means that patients can be treated outside of the hospital, increasing treatment options.

In conclusion, ABP 980 (Kanjinti) remains stable when stored in concentrated multi-dose bags (21 mg/mL) and diluted in IV bags and elastomeric devices (0.3 mg/mL–4 mg/mL). This provides extra preparation options for pharmacies around the world, which may have different practices and requirements.

Conflict of interest
Three of the authors of this study [1] are Amgen employees and stockholders; one is an employee of Baxter Healthcare. The testing performed for this study was funded by Amgen.

Editor’s comment
Readers interested to learn more about ABP 980 and other trastuzumab biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentrations and stress conditions

Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures

Clinical trials for trastuzumab biosimilars

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Reference
1. Davies L, Milligan K, Corris M, et al. Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(4):153-71. doi:10.5639/gabij.2021.1004.021

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