Trastuzumab biosimilar Kanjinti remains stable in polyolefin bags and elastomeric devices

Biosimilars/Research | Posted 01/04/2022 post-comment0 Post your comment

A study of the trastuzumab biosimilar ABP 980 (Kanjinti) finds that the compound remains stable in concentrated multi-dose bags and diluted in intravenous (IV) bags and elastomeric devices, providing preparation options to suit different global pharmacy practices.

Packaging

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

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
2.2 – CiteScoreTracker 2021 (Last updated on 6 March 2022)

Submit a manuscript to GaBI Journal

Related articles
Candidate trastuzumab biosimilar AryoTrust

Canada approves trastuzumab biosimilar Kanjinti

Trastuzumab biosimilar Kanjinti is stable over extended storage periods

LATIN AMERICAN FORUM

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View last week’s headline article: Nomenclatura de biológicos y biocomparables en México

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

LATIN AMERICAN FORUM

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de la semana pasada: Nomenclatura de biológicos y biocomparables en México

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

  

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010