BP708T AEC6 Biosimilars, Vaccines & Macromolecules (Theory) Syllabus — AKTU 2026-27

Syllabus

5 units · 15 lecture hours

Unit1

Unit 1

3 hrs

Introduction to Biosimilars, Vaccines and Macromolecules factors; primary/secondary/tertiary structures. delivery systems. biosimilar market.

Unit2

Unit 2

3 hrs

Characterization Methodologies -PAGE, SEC-HPLC, peptide mapping, mass spectrometry. -linked glycans (HILIC, lectin arrays). -based potency, binding ELISA, ADCC.

Unit3

Unit 3

3 hrs

Manufacturing Protocols optimization. -exchange), viral clearance. -finish: Lyophilization, aseptic processing, cold chain.

Unit4

Unit 4

3 hrs

Quality Control and Stability Protocols (LAL).

Unit5

Unit 5

3 hrs

Regulatory Compliances and Case Studies prequalification. -19 mRNA vaccines (Pfizer), Indian trastuzumab biosimilars.

Course Objectives6 points

The objectives of this course are to:
Introduce the fundamental concepts of biological macromolecules, biosimilars, and modern vaccine technologies used in pharmaceutical biotechnology.
Explain the physicochemical and functional characterization methods used for the analysis and comparability assessment of biologics and biosimilars.
Develop understanding of upstream and downstream manufacturing processes involved in the production of biopharmaceuticals and vaccines.
Describe quality control, stability testing, and immunogenicity assessment procedures applied to biologics and vaccine products.
Familiarize students with regulatory frameworks and approval pathways governing biosimilars and vaccines in India and global markets.

Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

CO1Describe the structure and therapeutic roles of biological macromolecules, biosimilars and vaccines.
CO2Apply analytical methodologies for characterization and bioequivalence assessment.
CO3Understand upstream and downstream processing and formulation protocols.
CO4Understand quality control, stability testing, and immunogenicity assessment methods used for ensuring the safety and efficacy of biologics and vaccines.
CO5Assess regulatory compliance requirements across the product lifecycle.

Recommended References (Preferably latest edition):3 books