Advanced analytical techniques for bioprocessing

Duration: 5 days
Price: £3,750+VAT

Our advanced courses are aimed at those working in research and development, process development and those are who are already working in the sector, who want to gain a deeper understanding of the theory and techniques used in biomanufacturing, understand and experience state-of-the-art techniques and methodologies, and appreciate the current and future challenges in biomanufacturing.

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

  • UKRI
  • atstn

    Training partners

  • Catapult Cell and Gene Therapy
  • Fujifilm
  • Pharmaron
  • cpi
  • Cytiva
  • Merck
  • ThermoFisher Scientific
  • Repligen
  • Chemometec
  • Cygnus Technologies
  • Sciex
  • Promega
  • Biomerieux

Delivered in partnership with industry leaders this five-day course provides in-depth training in analytical methodologies and technologies for the characterisation and qualification of therapeutic proteins, including antibodies, vaccines, and viral vectors. Hands-on practical sessions provide experience of state-of-the-art analytical methods for protein analysis, including gel electrophoresis, PCR primer design, immunoassays, cell counting and flow cytometry. Expert sessions will include strategy and common practices for the use of orthogonal methods for the assessment of product critical quality attributes – including product-related and process-related impurities, regulatory compliance as well as the application of design of experiments.

Module 1
• Protein structure and the importance of functionality
• Biological therapeutics and advanced therapies
• Getting to know your protein – an industry case study
• Analytics for cell & gene therapies
• Introduction to analytical ultracentrifugation
• Tour of the National Horizons Centre

Module 2
• Critical quality attributes for biologics
• PCR and applications in bioprocessing
• qRT-PCR solution for detection of residual host cell DNA
• Gene therapy - AAV analytical method development
• Rapid tests for mycoplasma detection in biotherapeutics
• Introduction to cell-based assays
• Lab - Bioinformatics primer design

Module 3
• Immunoassays for bioprocessing
• Surface plasmon resonance
• Protein analysis by electrophoresis
• Automated analytical solutions for protein bioprocessing
• Lab - SDS PAGE electrophoresis
• Imaging and data capture
• Lab – immunoassays

Module 4
• Design of experiments
• Introduction to slope spectroscopy
• Flow cytometry and cell sorting for biotherapeutics
• Host cell protein (HCP) immunoassays and integration of orthogonal methods
• Lab - Flow cytometry
• Lab - Manual cell counting, hands-on sample preparation and microscopy
• Lab - Automated cell counting

Module 5
• Liquid chromatography for bioprocessing
• HPLC analysis method development
• LC-MS for bioprocessing
• CE-MS from theory to practice
• Role of MS in HCP analytics
• Tour of the Waters Centre for Innovation

Learning outcomes:

  • Appreciate the challenges and considerations for the application and development of analytical methods for ensuring the manufacture of safe and efficacious biotherapeutic products including recombinant proteins, vaccines, and advanced therapies
  • Gain an appreciation of novel analytical techniques to allow real-time, at-line and on-line analysis
  • Further develop your skills in cell and product analysis through hands-on practical sessions and industry-led material.

Who should attend:

  • Analytical development scientists, process development scientists, QC analysts, and associated regulatory affairs, project management and quality assurance colleagues with at least 3 years’ experience of working in the biotechnology sector wishing to increase their knowledge of the analytical techniques employed within a modern bioprocessing plant, through lectures and hands-on training.

Course dates

Monday 28 November - Friday 2 December 2022

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

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