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