Complete introduction to bioprocessing

Duration: 5 days
Price: £3,750+VAT (academic discounts may be available, please enquire)

This five-day course is for delegates from process development, biomanufacturing operations, engineering, QC, QA and analytical development wishing to upskill and gain a thorough understanding of the theory and practical skills involved in the production of GMP biological products including biotherapeutics, vaccines and advanced therapies. Delegates will gain an appreciation of the scope of the biological products sector, processing strategies typically employed in biomanufacturing, the importance of understanding critical quality attributes and the role of analytical technologies in the production of safe and efficacious products.

The creation of this course has been funded by IUK through the ATSTN.

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Our unique training facility houses state-of- the-art equipment that provides delegates with the opportunity to gain hands-on practical training in complex bioprocessing procedures.

Module 1 - An introduction to biomanufacturing & advanced therapies

o Introduction to Bioprocessing
o Cell Biology and the Cell Cycle
o The Genetic Code – From DNA to Protein
o Protein Structure & Functionality
o GMP Environment, Cleanroom Design, Behaviour and Gowning
o The Biotherapeutics Landscape

Module 2 - Upstream strategies, technologies, and methods

o Introduction to Upstream Bioprocessing & Expression Systems
o Cell Production, Metabolism, Media and Seed Trains
o Bioreactors – Design and Function
o Handling Process Fluids and Ancillary Equipment
o Lab Activity - Cell Revival
o Lab Activity - Bioreactor Assembly
o Lab Activity - Cell Counting & Assessing Viability

Module 3 - Downstream strategies, technologies, and methods

o Introduction to Downstream Bioprocessing
o Depth Filtration
o Clarification and Flocculation
o Integrated Viral Safety
o DSP: Chromatography
o DSP: Tangential Flow Filtration (TFF)
o Lab Activity – TFF for Product Concentration and Buffer Exchange
o Sterile Grade Filters and Filter Integrity Testing

Module 4 - Analytical techniques for biomanufacturing

o CQAs for Biotherapeutics and Advanced Therapies
o Protein Analysis by Electrophoresis
o Lab Activity - SDS PAGE
o An Introduction to PCR
o An Introduction to Immunoassays
o Lab Activity – Gel Imaging and Data Interpretation
o Lab Activity - ELISA
o Introduction to HPLC and Mass Spec for the Analysis of Biotherapeutics and Advanced Therapies

Module 5 - Biomanufacturing challenges and emerging technologies

o Case Study 1: Overview of the Analytical Techniques used by a Biotherapeutics CDMO
o An Introduction to Flow Cytometry
o Case Study 2: Challenges of Applying Analytical Techniques to Advanced Therapies
o Current Challenges and Future Solutions for Biomanufacturing and Advanced Therapies
o Process Design Workshop

Learning outcomes:

• Appreciate the expectations of the personnel working within a GMP facility
• Understand the criteria use for selecting expression systems for different biotherapeutics
• Describe how bioreactors work and the operating parameters which should be monitored and controlled
• Evaluate CIP/SIP versus SU systems
• Recall the scope, application, and operational strategies for downstream technologies
• Recognise the importance of standard operating procedures in ensuring critical quality attributes are achieved and maintained
• Appreciate the range and application of analytical techniques for supporting the manufacture of biotherapeutics and advanced therapies

Who should attend:

• Scientists, engineers, manufacturing operators and managers wishing to enhance their understanding of modern GMP biomanufacturing. Typically, delegates would have < 3 years-experience within the biomanufacturing sector, although this course is also relevant for more experienced delegates switching roles to new areas of operation. This course is also suitable for academics, researchers, and students wishing to familiarise themselves with the rapidly expanding biomanufacturing and advanced therapies sectors.

Course dates

Monday 24 – Friday 28 October 2022
Monday 6 – Friday 10 March 2023

For enquiries and details of the full agenda please email CPDNHC@tees.ac.uk

Book now

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