The bioreactor animal cell culture process - Assay Method Development : After a cell line has been established and the resulting antibodies have been purified, the next step is to analyze the glycosylation patterns of the antibodies. Glycosylation analysis is essential in understanding the structure of the antibody that has been produced, and demonstrating its biosimilarity to the original drug in terms of safety, purity, and potency. Therefore, developing an elaborate assay for glycosylation analysis is essential in determining the overall success of the biologic. These assays must be conducted regularly, as cells are constantly undergoing change. In addition, the handling and preservation of biologics can be tricky, when compared to drugs, and there is always a risk for the drug being spoiled during distribution. Therefore, biologics need extra attention. 2) The Biosimilars and Novel Therapeutics of CELLTRION Products (Biosimilars) Product Name Target Original Name Major Development Substance Indication Status Remsima/Inflectra Infliximab Remicade (J&J) Autoimmune Approved by the diseases US FDA and MFDS. Also approved in EU, Canada and Japan Biosimilar Candidates Project Name Target Original Name Major Development Substance Indication Status CT-P06 Trastuzumab Herceptin (Roche) Breast cancer Approved by the MFDS CT-P10 Rituximab Rituxan/MabThera Non-Hodgkin Applied for AEMA (Roche) lymphoma approval CT-P05 Etanercept Enbrel (Amgen) Rheumatoid Pre-clinical study arthritis CT-P15 Cetuximab Erbitux (BMS) Colorectal Pre-clinical study cancer CT-P14 Palivizumab Synagis Respiratory Under process (Asterazeneca) diseases development
The bioreactor animal cell culture process - Assay Method Development : After a cell line has been established and the resulting antibodies have been purified, the next step is to analyze the glycosylation patterns of the antibodies. Glycosylation analysis is essential in understanding the structure of the antibody that has been produced, and demonstrating its biosimilarity to the original drug in terms of safety, purity, and potency. Therefore, developing an elaborate assay for glycosylation analysis is essential in determining the overall success of the biologic. These assays must be conducted regularly, as cells are constantly undergoing change. In addition, the handling and preservation of biologics can be tricky, when compared to drugs, and there is always a risk for the drug being spoiled during distribution. Therefore, biologics need extra attention. 2) The Biosimilars and Novel Therapeutics of CELLTRION Products (Biosimilars) Product Name Target Substance Original Name Major Indication Development Status Remsima/Inflectra Infliximab Remicade (J&J) Autoimmune diseases Approved by the US FDA and MFDS. Also approved in EU, Canada and Japan Biosimilar Candidates Project Name Target Substance Original Name Major Indication Development Status CT-P06 Trastuzumab Herceptin (Roche) Breast cancer Approved by the MFDS CT-P10 Rituximab Rituxan/MabThera (Roche) Non-Hodgkin lymphoma Applied for AEMA approval CT-P05 Etanercept Enbrel (Amgen) Rheumatoid arthritis Pre-clinical study CT-P15 Cetuximab Erbitux (BMS) Colorectal cancer Pre-clinical study CT-P14 Palivizumab Synagis (Asterazeneca) Respiratory diseases Under process development
ABOUT%20CELLTRION1.docx