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Semester VII · PCI syllabus 2026
Biosimilars, Vaccines & Macromolecules
BP708T-E6
1 credit
Elective
Coming soon
Unit 1: Unit 1
- Introduction to Biosimilars, Vaccines and Macromolecules
- Classes: Monoclonal antibodies (mAbs), cytokines, insulin, growth factors; primary/secondary/tertiary structures
Unit 2: Unit 2
- Biosimilars: Definition, rationale, types (e.g., erythropoietin, filgrastim)
- Vaccines: Generations (live, subunit, viral vector, mRNA); adjuvants and
- Industry landscape: Blockbuster biologics (Humira, Keytruda), Indian biosimilar market. Characterization Methodologies
- Physicochemical: SDS-PAGE, SEC-HPLC, peptide mapping, mass spectrometry
- Glycosylation analysis: N-linked glycans (HILIC, lectin arrays)
Unit 3: Unit 3
- Functional assays: Cell-based potency, binding ELISA, ADCC
- Comparability for biosimilars: Fingerprinting (ICH Q5E). Manufacturing Protocols
- Upstream: Cell line development (CHO, HEK), bioreactors, media optimization
- Downstream: Harvesting, chromatography (affinity, ion-exchange), viral
Unit 4: Unit 4
- clearance
- Fill-finish: Lyophilization, aseptic processing, cold chain
- Process analytical technology (PAT) in biologics. Quality Control and Stability Protocols
- Release testing: Host cell proteins (HCP), DNA, sterility, endotoxin (LAL)
- Stability: ICH Q5C for biologics; subvisible particles, aggregation
Unit 5: Unit 5
- Immunogenicity assessment: ADA assays, neutralizing antibodies
- Vaccine QC: Potency, identity, safety (animal models). Regulatory Compliances and Case Studies
- Global: USFDA 351(k) biosimilar pathway, EMA guidelines, WHO prequalification
- India: CDSCO Biosimilar Guidelines 2021, DCGI vaccine approvals
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