GL-2045: Applying QbD to cell Line development for a product with complex tertiary structure
Gliknik Inc. is developing GL-2045, a recombinant stradomerTM, for autoimmune diseases. It has demonstrated potent efficacy in numerous animal models. StradomersTM are recombinant compounds designed to improve on both pooled human intravenous immunoglobulin and also on antibody therapies used in immune disorders such as rheumatoid arthritis. To produce highly active product from the production CHO cell line, Gliknik evaluated product quality from many candidate production cell lines. This talk will describe the critical quality attributes (CQA) of the product and the application of QbD during cell line development to ensure that the resulting GL-2045 product contained the desired CQA.