Recently, we had the opportunity to sit down with H. Fai Poon, M.D., Ph.D., Director of Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China to discuss his background and experience with cell cultures and biosimilar development. During the podcast, he discusses his background, his company, and what he will be addressing at BioProcess International China taking place August 20-21 in Shanghai. 
On Tuesday, April 20, Dr. Poon will be presenting the case study Adjustment of Critical Quality Attribute (CQA) by Multivariate Analysis (MVA) in Biosimilar Media Supplement Development. Quality by Design (QbD) is the approach towards development and commercialization of biologics. In QbD, the process is designed and controlled to deliver critical quality attributes (CQA) consistently. Such process controls are particularly important for biosimilar development since they are required to demonstrate CQA similarity to reference drugs. We present a case study here that we applied multivariate analysis (MVA) to adjust the CQA of a biosimilar drug. CQA of a biosimilar product was adjusted to the reference drug criteria by cell culture media supplement optimization using MVA. Moreover, such optimization resulted in a more robust biomanufacturing process.
For more information on this session and the rest of the program, download the agenda. If you'd like to join us in Shanghai, as a reader of this blog when you register to join us and mention code BPIC13JP, you'll save 20% off the standard rate. Have any questions? Email Jennifer Pereira.
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