Advanced Cell Line Development & Bioprocess Technology: From Clone Selection to Commercial Manufacturing Readiness

A practitioner-led program covering advanced cell line engineering, clone selection, upstream and downstream process optimisation, and bioprocess strategies for improving biologics development and manufacturing outcomes.

Course Summary

The success of biologics manufacturing depends heavily on robust cell line development and scalable bioprocess strategies. Developing a high-performing production cell line requires integration of molecular engineering, clone screening, process optimisation, analytical characterisation and manufacturing considerations.

This one-day program provides a practical understanding of advanced cell line development and bioprocess technology, covering the journey from cell-line engineering and clone selection to upstream processing, downstream purification and commercial manufacturing readiness.

Participants explore how development teams optimise productivity, product quality, process robustness and scalability while managing challenges related to process variability, analytical characterisation and technology transfer.

The program focuses on practical industry applications, enabling participants to understand how scientific decisions during early development influence manufacturing performance and commercial success.

Who Should Attend

  • Biologics R&D Scientists
  • Cell Line Development Scientists
  • Upstream Process Development Teams
  • Downstream Process Development Teams
  • MSAT Professionals
  • Manufacturing Science Professionals
  • CMC Teams
  • Analytical Development Professionals
  • Bioprocess Engineers
  • R&D Leaders managing biologics development programs

Business Outcomes

Participants will be able to:

  • Understand the end-to-end cell line development lifecycle.
  • Evaluate key parameters influencing clone selection and productivity.
  • Improve understanding of upstream and downstream process optimisation.
  • Identify critical process parameters affecting product quality and yield.
  • Connect development decisions with manufacturing scalability.
  • Improve collaboration between R&D, MSAT and manufacturing teams.
  • Recognise technology-transfer considerations during process development.

Course Content

Cell Line Development Strategy and Engineering Approaches
Key Decision Factors 5 Topics
Activity: Clone Selection Case Study 2 Topics
Upstream Bioprocess Development and Optimisation
Critical Process Parameters (CPPs) 6 Topics
Process Optimisation Approaches 4 Topics
Hands-On Exercise: Upstream Process Optimisation Workshop 2 Topics
Downstream Processing and Purification Strategies
Overview of Downstream Processing 6 Topics
Process Optimisation Considerations 4 Topics
Managing Product Quality 4 Topics
Scale-Up Considerations 3 Topics
Case Discussion: Downstream Process Improvement Scenario 2 Topics
Process Characterisation, Scale-Up and Manufacturing Readiness
Building Process Understanding 3 Topics
Integrated Bioprocess Development Case Study
Scale-Up Challenges 4 Topics
Technology Transfer Considerations 4 Topics
Supporting Commercial Manufacturing 3 Topics
Activity: Bioprocess Readiness Assessment 4 Topics
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Meet Your Instructor
Dr. Saxena is an experienced biopharmaceutical professional with expertise in biologics, cell line development, viral vectors, and mRNA therapeutics. He has held leadership roles at Pfizer, Sun Pharma, Syngene, and Lonza, leading scientific teams and biologics development programs. He is currently a Visiting Faculty at IIT Tirupati and holds a Ph.D. in Biochemistry and Molecular Biology, along with postgraduate qualifications in Intellectual Property Law.
₹125,000.00
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This course includes:
  • Lessons 23
  • Topics 95
  • Duration 1 Day
  • Quizzes 0
  • Language English
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