Module 1 - Gene Cloning and expression in Prokaryotes

1. Polymerase Chain Reaction for amplification of gene of interest.
2. Plasmid Isolation and Restriction enzyme digestion/analysis.
3. Gene and plasmid purification.
4. Quantitation of purified plasmid DNA gene by Ultra violet spectroscopy and Agarose gel electrophoresis.
5. Ligation reaction and Bacterial Transformation.
6. Clone screening using PCR.
7. Clone characterization.
8. Transformation of clone DNA into expression host.
9. Protein expression.

Module 2. Gene Cloning and expression in Eukaryotes

1. PCR amplification of gene.
2. Plasmid Isolation and Restriction enzyme digestion/analysis.
3. Gene and plasmid purification.
4. Quantitation of purified plasmid DNA gene by Ultra violet spectroscopy and Agarose gel electrophoresis.
5. Ligation reaction and Bacterial Transformation.
6. Clone screening.
7. Clone characterization.
8. Transfection of clone DNA into the mammalian cells.
9. Clone selection.
10. Expression of protein from selected clones.
11. Protein characterization by Fluorescence, SDS PAGE and MALDI-TOF.

Module 3. Fermentation and upstream bioprocess of Prokaryotes

1. Seed culture
2. Bacterial fermentation
3. Growth of culture and induction
4. Monitoring parameters like OD, pH, DO and nutrient supplementation
5. Cell harvesting and cell lysis.
6. Washing and purification of inclusion body protein
7. Protein purification by affinity chromatography and characterization on SDS PAGE

Module 4. Bioreactor based cell culture & upstream process for mammalian cell culture

1. BIOREACTOR batch using selected clone
2. Inoculation of cells
3. Monitoring and maintaining parameters like pH, dissolved gases and nutrients.
4. Cell counting
5. Growth for two to three weeks
6. Batch harvesting
7. Purification of proteins from media using Chromatography techniques

Module 5. Protein Characterization

1. SDS PAGE
2. MALDI-TOF
3. Bioassay

Module 6 - Capillary Electrophoresis

1. Theory of CE
2. Development of CE methods
3. Validation of CE methods
4. Analysis of Erythropoietin
5. Analysis of Ascorbic Acid

Module 7 - LC-MS/MS

1. Theory of LC-MS/MS
2. Development of LC-MS methods
3. Validation of LC-MS methods
4. Analysis of Small Peptide
5. Impurity profiling of small peptides

Module 8 - Clinical Trial

1. Ethics of Clinical Trials
2. Regulatory compliances of Clinical trials
3. Protocol preparation (BE study as template)
4. CRF preparation (BE study as template)
5. IC process & Monitoring Clinical trial (BE study as template)

Module 9 - Knowledge Management

1. Importance of KM in today’s contest
2. Data-Information-Knowledge-Wisdom – Concepts & Relevance
3. Knowledge Classification – Tacit & Explicit Knowledge
4. Cost of Poor KM
5. Definitions and Terminology under KM
6. Objectives & Benefits of KM
7. Documents & Records
8. Lab Notebooks
9. Information Sourcing, including online examples
10. Reports – Technical reports, Preventive Action Reports, Corrective Action Reports
11. Methods of capturing Knowledge
    A. Case Study
    B. Rapid Evidence Review
    C. Knowledge Banks
    D. Community of Practice
    E. Peer Assist
    F. Knowledge Café
    G. Knowledge Marketplace
    H. Organizational Processes- Gone Well / Not Gone Well, After Action Review, Retrospective Review, Knowledge Exchange
12. KM Strategy & Implementation of KM in an organization
13. Measurement of the effectiveness of KM initiatives in an organizationv
14. Knowledge Management Frameworks
15. Resources & Skills requirements
16. KM Software & Tools

Module 10 - Intellectual Property Rights

1. Types of IPR – Patents, Trademarks & Service Marks, Copyright, Trade Secrets, Geographical Indications, Design Registration, Protection of New Plants & Varieties, Layout Design for Integrated Circuits, Utility Models.
2. Benefits of creating and / or owning patents.
3. Impact of IPR on global trade and economies of poor countries.
4. Need for harmonization of laws related to IPR.
5. WTO & TRIPS including articles of TRIPS Document
6. International Agreements related to IPR with special emphasis on Paris Convention, Budapest treaty, PCT & UPOV.
7. Online databases and exposure to Patent Search
8. IPC Classifications & INID Codes
9. Lab Documentation
10. Confidentiality Agreements
11. Filing of Patents - Criteria to be satisfied like patentability, inventiveness, non-obviousness, novelty, utility, sufficiency of disclosure, etc.
12. Indian Patent Laws & Patent Management – Provisional & Complete Specifications, Pre- and Post-grant Opposition and Servicing of Patents, Divisional Application & Patent of Addition.
13. Mutual Recognition Procedure & Orphan Drug
14. Extended Patent Protection
15. Anti-competitive Practices
16. Patent Offices & their Role in Patenting