Our experts de-risk your project by providing additional product quality assessments to ensure that the Quality Target Product Profile (QTPP) is on track to match originators. Additional early upstream process development can be performed using 15 or 250 ml multi-parallel robotic bioreactor systems to better match originator CQAs.
Whether you decide to stay with the originator or switch to a new host cell line, Abzena can advise on strategies for clone selection, process development and comparability studies to demonstrate that critical quality attributes affecting efficacy and safety are maintained.
We offer comprehensive analytical and bioassay packages to support clone selection minimizing process development time.
We can help you maintain biosimilarity, critical for the regulatory approval of biosimilar products, by developing your cell line using the originator cell type. We have access to a range of CHO, NS0 and Sp2/0 cell lines adapted to serum-free growth media.