Introduction

Biotechnology scale-up is a critical bridge between laboratory innovation and commercial biomanufacturing, enabling the transformation of bioprocesses from bench-scale experiments into industrial-scale production systems. Biotechnology Scale-Up Techniques Training Course provides a comprehensive, hands-on understanding of bioprocess scale-up, bioreactor optimization, fermentation technology, downstream processing, and GMP-compliant biomanufacturing workflows. Participants will gain practical exposure to cell culture expansion, microbial fermentation scale-up, process validation, and quality assurance systems that drive modern biopharmaceutical production, industrial enzymes, vaccines, and recombinant proteins.

With increasing global demand for biologics, biosimilars, precision medicine, and sustainable bio-based products, mastering scale-up techniques has become essential for biotechnology professionals. This course equips learners with advanced skills in process engineering, bioreactor design, oxygen transfer optimization, process control strategies, and regulatory compliance. Through real-world case studies and industry-relevant simulations, participants will understand how to reduce production costs, improve yield efficiency, and ensure consistent product quality in large-scale biotechnology manufacturing environments.

Programme Curriculum

Biotechnology Scale-Up Techniques Training Course

Introduction

Course Duration

5 days

Course Objectives

Understand bioprocess scale-up principles from lab to industrial production
Apply bioreactor design and optimization techniques for maximum yield
Analyze oxygen transfer rate (OTR) and kLa optimization strategies
Develop skills in fermentation technology and microbial cultivation scaling
Evaluate cell culture scale-up for mammalian and microbial systems
Implement process control and automation in biomanufacturing systems
Master downstream processing and purification scale-up methods
Apply GMP, FDA, and EMA regulatory compliance frameworks
Optimize bioprocess parameters using statistical and DoE approaches
Understand single-use bioreactor systems and continuous processing trends
Improve yield efficiency and productivity in large-scale fermentation
Apply tech transfer strategies from R&D to production plants
Integrate sustainable biomanufacturing and green biotechnology practices

Target Audience

Biotechnology engineers and bioprocess engineers
Biochemists and microbiologists
Pharmaceutical manufacturing professionals
Biomedical and biochemical engineering students
QA/QC professionals in biopharma industries
R&D scientists in biotech companies
Fermentation and industrial microbiology specialists
Regulatory affairs and validation specialists

Course Modules

Module 1: Fundamentals of Bioprocess Scale-Up

Principles of laboratory-to-industrial transition
Bioprocess flow and unit operations overview
Scaling laws and similarity criteria
Material and energy balance in bioprocessing
Case Study: Scale-up of insulin production using recombinant E. coli fermentation

Module 2: Bioreactor Design and Engineering

Types of bioreactors
Mixing, aeration, and agitation systems
Sensor integration and control systems
Sterilization and contamination control
Case Study: Industrial-scale monoclonal antibody production in stirred-tank bioreactors

Module 3: Fermentation Technology and Microbial Scale-Up

Batch, fed-batch, and continuous fermentation
Media optimization and nutrient feeding strategies
Oxygen transfer and metabolic regulation
Scale-up challenges in microbial systems
Case Study: Penicillin industrial fermentation scale-up optimization

Module 4: Mammalian Cell Culture Scale-Up

CHO cell line expansion techniques
Serum-free and suspension culture systems
Shear stress management in large bioreactors
Cell viability and productivity optimization
Case Study: Scale-up of erythropoietin (EPO) production in CHO cells

Module 5: Downstream Processing and Purification

Cell harvesting and clarification methods
Chromatography scale-up strategies
Filtration and centrifugation technologies
Product recovery and purification efficiency
Case Study: Industrial purification of recombinant monoclonal antibodies

Module 6: Process Control and Automation

SCADA systems in biomanufacturing
Real-time monitoring and PAT tools
Data analytics and process optimization
Feedback and feedforward control systems
Case Study: Automated vaccine production monitoring system

Module 7: Regulatory Compliance and GMP Scale-Up

GMP guidelines in bioprocessing
Technology transfer documentation
Validation and qualification protocols
Risk assessment and quality systems
Case Study: FDA-approved biosimilar manufacturing scale-up

Module 8: Advanced Trends in Biomanufacturing

Single-use bioreactor systems
Continuous bioprocessing technologies
AI and machine learning in bioprocess optimization
Sustainable and green biotechnology approaches
Case Study: Continuous production of viral vectors for gene therapy

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: info@fineskilltrainingcenter.org or call +254769199797

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 Fineskill Training Center account, as indicated in the invoice so as to enable us prepare better for you.

Skills & Software Covered

Bioreactor design Cell culture scaling Fermentation optimization Process control

Programme Fee

Duration: 5 Days

Method: Online or Physical

Online Price: $1,000

Physical Price: $1,500

Certification: Accredited Certificate

View Available Dates 📄 Download Course Outline (PDF)

Available Sessions

Location

Month

Year

Sep 21 2026

21 Sep — 25 Sep 2026

💻 Online / Virtual session

Online $1,000