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The document outlines the topics and time allotments for basic and advanced training courses on biosimilar development. The basic training course covers topics like the basics of biosimilars, commercialized biosimilars globally and in India, clone development, host systems, upstream and downstream bioprocessing, bioanalytical techniques, and stability and formulation over 8 sessions totaling 50 hours. The advanced training expands on these topics and also includes additional sessions on CMC approaches, process development strategies, case studies on specific products, analytical techniques, regulations and hands-on time with equipment.
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Studies on the viabile bacteria of commercial probiotic products available in...
Training course
- 1. Basic training on Biosimilar Development: Sr.No Topic Time 1. Basics of Biosimilar/Biologics/Biogenerics 2.5 Hrs 2. General Introduction of Commercialized Biosimilar- Peptide,Proteins,Mabs- Indian and Global view 3.5 Hours 3. Clone development for Biosimilar/Biologics/Mabs 3.5 Hours 4. General introduction of host - Prokaryotic/Eukaryotic and Cell culture for Biosimilars/Biologics 3.5 Hours 5. Upstream Biology of Biosimilar/Biologics 5 Hours 6. Downstream Biology of Biosimilars/Biologics 5 Hours 7. Bioanalytical Techniques for Biosimilars/Biologics 5 Hours 8. Stability and Formulation of Biosimilars / Biologics 5 Hours Advanced Training on Biosimilar Development: Sr.No Topic Time 1. Basics of Biosimilar/Biologics/Biogenerics 2.5 Hrs 2. General Introduction of Commercialized Biosimilar- Peptide,Proteins,Mabs- Indian and Global view 3.5 Hours 3. Clone development for Biosimilar/Biologics/Mabs 3.5 Hours 4. General introduction of host - Prokaryotic/Eukaryotic and Cell culture for Biosimilars/Biologics 3.5 Hours 5. Upstream Biology of Biosimilar/Biologics 5 Hours 6. Downstream Biology of Biosimilars/Biologics 5 Hours 7. Bioanalytical Techniques for Biosimilars/Biologics 5 Hours 8. Stability and Formulation of Biosimilars / Biologics 5 Hours 9 CMC Approach for Biosimilar/Biologics development 5 Hours 10 PAT,DOE Approach for Biosimilar development 5 Hpurs 11 Case study on recombinant proteins(Biosimilars) development 5 Hours 12 Case study on Mabs 5 Hours 13 Complete process for GCSF development 5 Hours 14 Complete process for Rituximab Development 5 Hours 15 Column chromatography for purification of Biosimilars 5 Hours 16 Cell lines used in biosimilar development 5 Hours 17 Regulatory filling for Biosimilars 5 Hours 18 Fermentors- Operation 5 Hours 19 Akta Purification System- Operation 5 Hours 20 Bioanalytical techniques-SDS PAGE,NATIVE,WESTERN,ELISA,LCMS,GCMS,RP- HPLC,CZE,ETC 7.5 Hours