Course

Unit 1

Unit 1:

Introduction to Cell Culture, History and applications of cell culture, Laboratory setup and biosafety levels, Types of cell cultures: primary cells, continuous cell lines, stem cells, Overview of aseptic techniques and contamination control, Cell culture media: composition, preparation, and storage.

Unit 2

Unit 2:

Maintenance and Handling of Cell Lines, Thawing, subculturing, and cryopreservation techniques, Cell counting and viability assays (e.g., trypan blue exclusion), Morphological characterization and authentication of cell lines, Detection and management of contamination (bacterial, fungal, mycoplasma)

Unit 3

Unit 3:

Advanced Cell Culture Applications, 3D cultures, co-culture systems, and organoids, Serum-free and chemically defined media, Transfection techniques and genetic manipulation, Applications in drug screening, toxicity testing, and regenerative medicine.

Unit 4

Unit 4:

Introduction to Bio-processing, Overview of bio-processing in biotechnology and pharma, Upstream vs. downstream processing, Types of bioreactors (batch, fed-batch, continuous), Parameters in bioreactor operations: pH, DO, temperature, agitation.

Unit 5

Unit 5:

Scale-Up and Biomanufacturing, Principles of scale-up from flask to pilot to production scale, Media optimization and cell density enhancement strategies, Process monitoring and control strategies, Case studies: production of monoclonal antibodies, vaccines, and recombinant proteins.

Unit 6

Unit 6:

Quality Control, Regulatory, and Emerging Trends, GMP and GLP in bioprocessing, Quality control and assurance in cell culture and bio-processing, Regulatory considerations for bioproducts, Emerging technologies: single-use bioreactors, PAT (Process Analytical Technology), and automation.

(45 classes)

Preamble:

This course introduces students to the fundamental principles and practices of cell culture, including aseptic techniques, media preparation, and maintenance of various cell lines. It further delves into bio-processing strategies employed in the biotechnology and pharmaceutical industries, focusing on bioreactor operations and scale-up methodologies. Emphasizing both theoretical concepts and practical applications, the curriculum prepares students for roles in biomanufacturing and process development.

Course Outcomes:

CO1: Explain the principles, applications, and laboratory practices of cell culture, including aseptic techniques and media preparation.

CO2: Perform key procedures for cell line maintenance, including thawing, subculturing, cryopreservation, and contamination control.

CO3: Describe and apply advanced cell culture methods such as 3D cultures, co-cultures, and transfection techniques.

CO4: Understand the fundamentals of bio-processing and differentiate between upstream and downstream processes.

CO5: Outline scale-up strategies and biomanufacturing workflows for therapeutic product development.

CO6: Recognize quality control, regulatory guidelines, and emerging technologies in cell culture and bio-processing.

Program outcome

PO1: Bioscience Knowledge

PO2: Problem Analysis

PO3: Design/Development of Solutions

PO4: Conduct Investigations of complex problems

PO5: Modern tools usage

PO6: Bioscientist and Society

PO7: Environment and Sustainability

PO8: Ethics

PO9: Individual & Team work

PO10: Communication

PO11: Project management & Finance

PO12: Lifelong learning

0 – No affinity; 1 – low affinity; 2 – Medium affinity; 3 – High affinity

Program-specific outcome

PSO 1 – Emerging technologies in cell therapy

PSO 2 – Biomolecules in Medicine

PSO 3 – Molecular dysregulation in diseases

PSO 4 – Molecular technology in diagnosis and therapy

PSO 5 – Applying lab discoveries to clinical practice

PSO 6 – Advanced techniques in cell culture, gene editing, and bioprocessing

PSO 7 – Statistical methods to interpret and validate diagnostic results

PSO 8 – Integrate cell therapy into personalized medicine

PSO 9 – GMP and regulatory practices in cell therapy production

PSO 10 – Bioinformatics and biological data use

0 – No affinity; 1 – low affinity; 2 – Medium affinity; 3 – High affinity

Textbook

Doran, P. M. (2013). Bioprocess Engineering Principles (2nd ed.). Academic Press.

Freshney, R. I. (2016). Culture of Animal Cells: A Manual of Basic Technique and Specialized Applications (7th ed.). Wiley-Blackwell.

Reference

Shuler, M. L., & Kargi, F. (2002). Bioprocess Engineering: Basic Concepts (2nd ed.). Prentice Hall.

Thermo Fisher Scientific. (2016). Cell Culture Basics: Handbook. Thermo Fisher Scientific Inc.