Biosimilar Cell Line Development
Biosimilars are a relatively new field in the biopharmaceutical industry and present a unique challenge for biosimilar manufacturers. Biosimilars are recombinant therapeutics that resemble but are not identical to the original product, mainly due to the difficulty in precisely matching the structure and composition of these large complex biological molecules. Specifically matching critical product quality attributes, such as glycoprofile, protein aggregation, clips or truncation is a challenge to many biosimilar developers. However, Cellca’s unique platform technology enables the expression of antibody products with different protein quality attributes using only a single host cell line. As presented in the figure below, the Cellca CHO DG44 host cell line offers a broad flexibility expressing different antibody products regarding several quality attributes.
Cellca has devised a strategy that utilizes the Cellca CHO Expression Platform for biosimilar cell line development. Taking critical quality attributes into consideration from the very start of the development program. By realizing this strategy in our development labs, Cellca scientists are able to choose the right clones at the clone selection stage and to maximise clients’ chances of successfully developing a biosimilar.
The Cellca CHO Expression Platform can be used for the development of biosimilar cell lines with the added benefit of utilising BioOutsource’s industry leading analytical characterisation and comparability expertise. BioOutsource can monitor the development of the cell line at every stage of the platform cycle to assess for comparability to the originator molecule. Based on this crucial data, Cellca can carry out process and media optimisation where required to modify the quality attributes of the biosimilar according to the reference product.
For this purpose, several conditions have been identified to increase or reduce e.g. glycan profiles in small scale and have also been successfully applied for different antibody products.
Below is a graph showing that successful modifications made to the glycan profile during process optimisation of an antibody producing Cellca cell line are scalable to different bioreactor volumes and types.
Utilising Cellca and BioOutsource’s expertise and capabilities can help you mitigate risks at the critical, early stage of biosimilar development.
Contact our experts today to discuss your biosimilar cell line development.