Advanced Cell Line Development and Engineering Training Course

Advanced Cell Line Development and Engineering Training Course

Introduction

Advanced Cell Line Development and Engineering Training Courseprovides an in-depth look into the Advanced Cell Line Development and Engineering training program. Advanced Cell Line Development and Engineering Training Course is designed to empower professionals in the biopharmaceutical and biotechnology sectors with the cutting-edge knowledge and practical skills required to innovate, optimize, and scale biotherapeutic production. By focusing on trending keywords and industry best practices, this training ensures participants can meet the demands of modern biomanufacturing.

The course delves into the core principles of genetic engineering, CRISPR-Cas9 technology, and high-throughput screening, which are critical for creating stable and highly productive cell lines. Participants will learn to navigate the complexities of bioreactor operations, process monitoring, and Quality by Design (QbD), all of which are essential for ensuring product quality and regulatory compliance. This comprehensive program is a vital step for anyone looking to advance their career in bioprocessing, regenerative medicine, and gene therapy development.

Course Duration

10 days

Course Objectives

• Master the principles of mammalian cell line development and genetic engineering.
• Implement CRISPR-Cas9 and TALEN for precise cell line engineering.
• Design and optimize expression vectors for high-titer protein production.
• Apply high-throughput screening to identify top-performing clones.
• Develop stable cell lines for biopharmaceutical manufacturing.
• Understand the role of Quality by Design (QbD) in cell line development.
• Troubleshoot common challenges in cell culture and bioprocessing.
• Evaluate and select appropriate host cell systems (e.g., CHO cells).
• Utilize automation and data analytics to streamline workflows.
• Integrate omics technologies (genomics, proteomics) into the development process.
• Characterize cell lines for product quality and stability.
• Ensure compliance with cGMP and regulatory guidelines.
• Prepare and maintain a GMP-compliant Master Cell Bank.

Organizational Benefits

• Faster development of high-performing cell lines reduces time-to-market for new biotherapeutics.
• Optimized cell lines lead to higher yields and reduced manufacturing costs.
• Improved genetic stability and control over post-translational modifications result in consistent, high-quality products.
• Adherence to cGMP and ICH guidelines minimizes risks during regulatory filings and inspections.
• Skilled workforce capable of implementing next-generation technologies like gene editing and automation.
• Efficient screening and optimization processes minimize material waste and labor hours.
• Early identification of potential issues in cell line performance and stability.

Target Audience

• Cell Culture Scientists & Bioprocess Engineers
• Research & Development Scientists
• Process Development Specialists
• Biomanufacturing Professionals
• Quality Assurance/Quality Control (QA/QC) Specialists
• Regulatory Affairs Professionals
• Project Managers in the biopharma sector
• Academics and students pursuing careers in biotechnology

Course Modules

Module 1: Foundations of Cell Line Development (CLD)

• Principles of host cell selection (e.g., CHO, HEK293, NS0).
• Fundamentals of recombinant protein expression.
• Overview of the CLD workflow from transfection to banking.
• Regulatory considerations for cell lines in biomanufacturing.
• Case Study: Selection of a stable CHO-K1 cell line for mAb production.

Module 2: Advanced Genetic Engineering & Gene Editing

• Mechanisms of CRISPR-Cas9, TALENs, and zinc finger nucleases.
• Designing and implementing gene editing strategies for enhanced expression.
• Methods for targeted gene insertion and knockout.
• Strategies for metabolic engineering of host cells.
• Case Study: Using CRISPR to knockout a gene that produces a non-human glycan in a CHO cell line.

Module 3: Vector Design & Optimization

• Components of high-performance expression vectors.
• Codon optimization and signal sequence selection.
• Using proprietary expression platforms (e.g., CHEF1).
• Stable vs. transient transfection methods.
• Case Study: Comparing the performance of different vector designs for an oncology protein.

Module 4: Transfection & Stable Pool Generation

• Optimizing transfection parameters for various cell types.
• Chemical, electrical, and viral transfection techniques.
• Drug selection and clonal pool generation.
• Assessing pool performance for titer and quality.
• Case Study: A protocol for high-efficiency electroporation of CHO cells.

Module 5: High-Throughput Screening (HTS) & Automation

• Microtiter plate-based screening and colony picking.
• Using automated platforms (e.g., ClonePix, CellCelector).
• Developing screening assays for titer and product quality.
• Data management and analysis for HTS data.
• Case Study: Implementing an automated HTS workflow to screen thousands of clones.

Module 6: Single Cell Cloning & Monoclonality

• Importance of monoclonality for regulatory compliance.
• Methods for ensuring monoclonality (e.g., FACS, single-cell dispensers).
• Documenting monoclonality with imaging and reporting.
• Clonal outgrowth and expansion strategies.
• Case Study: Verifying monoclonality using the Solentim VIPS system.

Module 7: Cell Culture Optimization & Media Development

• Principles of fed-batch and perfusion cultures.
• Designing chemically defined media and feed strategies.
• Optimizing critical process parameters (CPPs) like pH and DO.
• Troubleshooting cell culture performance issues.
• Case Study: Enhancing mAb production through a custom feed strategy.

Module 8: Bioreactor Operations & Process Scale-up

• Principles of bioreactor design and operation.
• Scale-up from shake flasks to benchtop and pilot-scale bioreactors.
• Strategies for process intensification (e.g., N-1 perfusion).
• Using single-use bioreactor technologies.
• Case Study: Scaling up a cell culture process from a 2L to a 50L bioreactor.

Module 9: Process Monitoring & PAT

• In-line and at-line analytical tools for real-time monitoring.
• Using Process Analytical Technology (PAT) for process control.
• Key performance indicators (KPIs) for cell culture runs.
• Applying multivariate data analysis (MVDA) to process data.
• Case Study: Using a Raman spectroscopy probe to monitor nutrient levels in real-time.

Module 10: Characterization & Product Quality Attributes (PQAs)

• Assessing cell line stability and genetic integrity.
• Analytical techniques for protein characterization (e.g., HPLC, Mass Spec).
• Measuring critical quality attributes (CQAs) like glycosylation.
• Relationship between cell culture conditions and product quality.
• Case Study: Analyzing glycan profiles of a biotherapeutic from different clones.

Module 11: Regulatory & Quality Management

• Overview of cGMP regulations for cell line development.
• Documentation and record-keeping for regulatory submissions.
• Risk-based approaches and Quality by Design (QbD).
• Audit preparation and compliance.
• Case Study: A mock regulatory audit of a cell line development lab.

Module 12: Cell Bank Creation & Management

• Protocols for creating a Master Cell Bank (MCB) and Working Cell Bank (WCB).
• Cryopreservation techniques and stability testing.
• QC testing for identity, sterility, and genetic stability.
• Managing cell bank storage and traceability.
• Case Study: Developing a robust cell banking and QC protocol.

Module 13: Next-Generation Technologies

• Introduction to cell and gene therapies.
• Stem cell engineering and iPSC applications.
• Single-cell omics and its impact on CLD.
• Future trends in biomanufacturing.
• Case Study: Using single-cell RNA sequencing to profile top-performing clones.

Module 14: Computational Biology & Machine Learning

• Using bioinformatics tools for sequence analysis.
• Applying machine learning to predict cell line performance.
• Data visualization and interpretation.
• Building predictive models for clone selection.
• Case Study: Developing a machine learning model to predict titer from genomic data.

Module 15: Troubleshooting & Continuous Improvement

• Systematic approaches to problem-solving in CLD.
• Root cause analysis (RCA) for process deviations.
• Implementing corrective and preventive actions (CAPA).
• Fostering a culture of continuous improvement.
• Case Study: Investigating and resolving a sudden drop in viable cell density during a bioreactor run.

Training Methodology

This course employs a participatory and hands-on approach to ensure practical learning, including:

• Interactive lectures and presentations.
• Group discussions and brainstorming sessions.
• Hands-on exercises using real-world datasets.
• Role-playing and scenario-based simulations.
• Analysis of case studies to bridge theory and practice.
• Peer-to-peer learning and networking.
• Expert-led Q&A sessions.
• Continuous feedback and personalized guidance.

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.