Transcription of A QUALITY DRIVEN BIOSIMILAR DEVELOPMENT - …
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A QUALITY DRIVEN BIOSIMILAR DEVELOPMENT - …
A QUALITY DRIVEN BIOSIMILAR . DEVELOPMENT . AN AVERSE RISK APPROACH. SEPTEMBER 17TH, 2015. Amman, Jordan AFTER LUNCH TEST: FIND THE DIFFERENCE. ? September 2015 / 2. CHALLENGES IN BIOSIMILAR DEVELOPMENT . Originator Similarity of BIOSIMILAR Structure Biological Activity Stability Safety Efficacy September 2015 / 3. OUTLINE. Understand the Complexity of Biologics Define the Originator QUALITY Target Product Profile Achieve Biosimilarity September 2015 / 4. N-GLYCOSYLATION BIOSYNTHESIS. September 2015 / 5. COMPLEXITY OF N-GLYCOSYLATION IN HUMANS. September 2015 / 6. TYPICAL BIOSIMILAR DEVELOPMENTS. Reference Produced in Produced in Active Ingredient Reference Product Active Ingredient Product Glycans per Chain Glycans per Chain CHO Nutropin Somatropin Avastin Bevacizumab 1xN (IgG1). CHO. Octocog alpha Factor VIII. Avonex Interferon beta-1a 25xN+12xO. PEG-Interferon alpha- NS0 Pegasys Benlysta Belimumab 2a 1xN (IgG1). Proleukin Interleukin-2.
september 17th, 2015 . a quality driven biosimilar development . an averse risk approach . amman, jordan
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