Advanced Cell Culture Media Optimization Training Course

Advance Cell Culture Media Optimization Training Course

Introduction

The biopharmaceutical and biotechnology industries are undergoing a massive transformation, with a growing demand for high-quality, cost-effective biological products. At the heart of this revolution is cell culture, a fundamental process that underpins the production of everything from monoclonal antibodies to cell therapies. However, traditional media formulations are often costly and lack consistency, posing significant challenges to process scalability and product quality. This has created a critical need for advanced expertise in cell culture media optimization. Advance Cell Culture Media Optimization Training Course is specifically designed to equip scientists and engineers with the cutting-edge knowledge and practical skills required to develop chemically defined media that enhance cell growth, improve protein expression, and ensure the highest levels of product quality and process robustness. This is not just a theoretical course; it is a deep dive into the practical application of modern techniques to solve real-world bioprocessing challenges.

This program goes beyond basic protocols, focusing on the latest innovations in media development and bioprocess optimization. Participants will learn how to leverage high-throughput screening, metabolic flux analysis, and omics technologies to rationally design media that are tailored to specific cell lines, thereby maximizing bioreactor productivity. We will explore strategies to overcome common issues like nutrient depletion and metabolic stress, ensuring a more stable and efficient production process. By mastering these advanced methodologies, professionals can significantly reduce development timelines and production costs, directly contributing to the commercial success and competitive advantage of their organizations. Our expert-led curriculum integrates case studies from industry leaders, providing a practical and applied learning experience that is directly transferable to the laboratory and manufacturing floor.

Course Duration

10 days

Course Objectives

1. Master the principles of designing chemically defined and serum-free media for diverse cell lines.
2. Implement automated high-throughput screening workflows for rapid media component optimization.
3. Utilize MFA to understand cellular metabolism and identify key nutritional bottlenecks.
4. Apply proteomics, metabolomics, and transcriptomics to gain a holistic view of cellular behavior in culture.
5. Develop media strategies for fed-batch and perfusion cultures to achieve higher cell densities and productivity.
6. Optimize amino acid, glucose, and vitamin concentrations for enhanced growth and protein expression.
7. Incorporate QbD principles into media development to ensure product consistency and quality attributes.
8. Diagnose and resolve common media-related issues, such as lactate accumulation and ammonia toxicity.
9. Design media formulations that are robust and scalable from small-scale shake flasks to large-scale bioreactors.
10. Integrate media optimization with other upstream process parameters like pH, dissolved oxygen, and temperature.
11. Understand the regulatory requirements and documentation for using chemically defined media in GMP manufacturing.
12. Conduct a cost-benefit analysis of different media components to reduce overall production costs.
13. Employ machine learning and design of experiments (DoE) to accelerate the media development cycle.

Organizational Benefits

• Achieve higher cell densities and product titers, leading to a significant increase in overall bioreactor productivity.
• Lower expenses associated with raw materials and development timelines by optimizing media formulations.
• Enhance key product attributes like glycosylation and stability, ensuring a higher-quality final product.
• Minimize batch-to-batch variability and a more reliable and consistent manufacturing process.
• Stay ahead of the competition by implementing the latest bioprocessing innovations and a more efficient workflow.
• Accelerate the development cycle from research to large-scale production, allowing for quicker market entry for new products.
• Simplify regulatory submissions by using well-defined, serum-free media that reduce the risk of contaminants.
• Cultivate an in-house team of experts proficient in modern cell culture techniques and bioprocess development.

Target Audience

• Cell Culture Scientists.
• Bioprocess Engineers.
• Process Development Specialists.
• R&D Scientists.
• Quality Assurance/Quality Control (QA/QC) Professionals.
• Manufacturing Professionals.
• Project Managers.
• Graduate Students & Post-Docs.

Course Modules

Module 1: Fundamentals of Advanced Cell Culture

• Evolution of Media: From serum-containing to chemically defined media.
• Cellular Metabolism: In-depth look at key metabolic pathways and their impact on productivity.
• Media Components: A comprehensive breakdown of amino acids, vitamins, trace elements, lipids, and growth factors.
• Bioreactor Systems: Overview of different bioreactor types and their use in bioprocess development.
• Case Study: The shift from hybridoma technology to CHO cells in monoclonal antibody production.

Module 2: Media Design & Formulation

• Rational Design Principles: Strategies for building a media formulation from the ground up.
• Screening Methodologies: Comparison of single-factor and multi-factor screening techniques.
• Design of Experiments (DoE): Applying DoE to identify and optimize key media components.
• Nutrient Feeding Strategies: Introduction to bolus, continuous, and dynamic feeding protocols.
• Case Study: Optimizing a CHO cell media formulation using a fractional factorial DoE approach.

Module 3: High-Throughput Screening & Automation

• Microbioreactor Technology: Using microbioreactors for rapid, small-scale media screening.
• Liquid Handling Systems: Introduction to automated platforms for precise media preparation and dispensing.
• High-Content Imaging: Utilizing automated microscopy to analyze cell growth and morphology.
• Data Analysis & Visualization: Tools and software for processing and interpreting large screening datasets.
• Case Study: A pharmaceutical company's use of robotic liquid handlers to screen hundreds of media conditions.

Module 4: Metabolic Analysis & Omics Integration

• MFA Basics: Calculating metabolic flux to understand nutrient consumption and by-product formation.
• Isotope Tracing: Using stable isotopes to map metabolic pathways in live cells.
• Proteomics & Metabolomics: Analyzing protein expression and metabolite profiles to guide media design.
• Transcriptomics: Understanding gene expression changes in response to media components.
• Case Study: Identifying the metabolic bottleneck in a low-producing cell line using 13C-MFA.

Module 5: Process Intensification & Perfusion Cultures

• Perfusion Bioreactors: Principles of perfusion culture for achieving high cell densities.
• Cell Retention Devices: Review of different devices like hollow fiber filters and acoustic separators.
• Media Exchange Strategies: Optimizing the perfusion rate to balance nutrient supply and waste removal.
• Sensor Technology: Using online sensors for real-time monitoring of key process parameters.
• Case Study: Implementing a perfusion process to double the volumetric productivity of an mAb.

Module 6: Troubleshooting & Problem-Solving

• By-Product Toxicity: Strategies to mitigate the effects of lactate and ammonia accumulation.
• Contamination Control: Best practices for preventing and managing microbial contamination.
• Cell Viability & Apoptosis: Techniques for measuring cell health and addressing cell death in culture.
• Critical Quality Attributes (CQAs): Ensuring media optimization does not negatively impact product quality.
• Case Study: A detailed root-cause analysis of a sudden drop in productivity due to media-induced apoptosis.

Module 7: Advanced Feed Strategies & Supplements

• Amino Acid Supplementation: Tailoring amino acid feeds to specific cell line requirements.
• Lipid & Vitamin Optimization: Role of lipids and vitamins in cell growth and membrane integrity.
• Exogenous Supplements: The use of hydrolysates, peptones, and other complex feeds.
• Designer Feeds: Creating custom feeds to boost cell-specific productivity.
• Case Study: Using a two-part feed strategy to extend the culture duration and increase the final titer.

Module 8: Scale-Up & GMP Manufacturing

• Scale-Up Principles: Applying small-scale optimization data to large-scale bioreactors.
• Media Preparation: Best practices for manufacturing large volumes of media under GMP.
• Supply Chain Management: Sourcing and qualifying raw materials for commercial production.
• Regulatory Documentation: Preparing documentation for regulatory filings related to media.
• Case Study: The successful scale-up of a new serum-free media formulation from 2L to 2,000L.

Module 9: Protein Expression & Glycosylation

• Media Impact on Glycosylation: How media components influence protein glycosylation patterns.
• Glycoengineering: Strategies to modify glycosylation using media supplements.
• Recombinant Protein Yields: Enhancing the expression of complex recombinant proteins.
• Product Stability: Improving the stability of the final product in culture.
• Case Study: A company’s efforts to improve the pharmacokinetics of a therapeutic protein by optimizing its glycosylation.

Module 10: Economic & Commercial Considerations

• Cost of Goods (CoG): Analyzing the impact of media choices on the overall CoG.
• Media Sourcing: Evaluating different suppliers and raw material quality.
• Make vs. Buy Analysis: Deciding between in-house media formulation and purchasing off-the-shelf media.
• Intellectual Property: Understanding IP considerations in media development.
• Case Study: A comparison of the economic benefits of using a custom-designed media versus a commercial standard.

Module 11: Single-Use Technologies & Automation

• Single-Use Bioreactors: Integrating media optimization with single-use systems.
• Automated Sampling: Using automated systems for real-time sample collection.
• Digital Twins: Creating digital models of the bioprocess to predict outcomes.
• Industry 4.0: The role of automation and data in modern biomanufacturing.
• Case Study: A factory's implementation of a fully automated, single-use upstream process.

Module 12: Gene & Cell Therapy Applications

• Viral Vector Production: Optimizing media for high-titer viral vector production.
• Stem Cell Expansion: Media requirements for the proliferation and differentiation of stem cells.
• Cell Therapy Manufacturing: The unique challenges of media for cell therapy products.
• GMP Compliance: Specific regulatory considerations for media used in cell and gene therapies.
• Case Study: Optimizing a media formulation for the large-scale production of CAR-T cells.

Module 13: Advanced Analytics & Monitoring

• Flow Cytometry: Using flow cytometry to assess cell viability, count, and phenotype.
• Raman Spectroscopy: Applying in-line spectroscopy for real-time, non-invasive process monitoring.
• Mass Spectrometry: Advanced use of MS for detailed media component analysis.
• Multivariate Data Analysis (MVDA): Using statistical tools to analyze complex data sets.
• Case Study: A company's use of in-line Raman spectroscopy to control a fed-batch process.

Module 14: Quality by Design (QbD) in Media Development

• QbD Framework: The principles of QbD and their application in bioprocessing.
• Critical Process Parameters (CPPs): Identifying and controlling key media-related parameters.
• Design Space: Defining the operational range for media components to ensure robust performance.
• Control Strategy: Developing a robust control strategy for media-related aspects of the process.
• Case Study: A QbD approach to developing a media formulation for a new biosimilar.

Module 15: Future Trends & Emerging Technologies

• Machine Learning (ML): The use of ML algorithms for predictive media optimization.
• AI in Bioprocessing: The role of artificial intelligence in accelerating process development.
• Synthetic Biology: Designing novel cellular pathways to improve productivity.
• Continuous Manufacturing: The future of continuous bioprocessing and media requirements.
• Case Study: A start-up's use of an AI-driven platform to design a novel media formulation.

Training Methodology

Our training is a dynamic blend of theoretical instruction and hands-on, practical application. The methodology is designed to provide participants with both a deep conceptual understanding and the practical skills needed to implement these techniques immediately.

• Interactive Lectures.
• Practical Workshops.
• Case Studies & Problem-Solving.
• Live Demonstrations.
• Group Discussions.

Register as a group from 3 participants for a Discount

Send us an email: [email protected] or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.