Navigating QC Testing for Biologics and Biosimilars

Course Descriptor

A Critical Quality Attribute (CQA) of a drug is defined as a ‘physical, chemical, biological, or microbiological property…that should be within an appropriate limit…to ensure the desired product quality’ (ICH Q8 (R2)).  For biopharmaceuticals and biosimilars, these include properties such as amino acid sequence, post-translational modifications, intact mass and higher-order structures, biological activity, process and product related impurities and stability, among many others.  With such physicochemical complexity informing drug S&E, many orthogonal techniques are required for robust and unequivocal quality data.

This three-day course guides trainees through the CQAs of biologics (ICH Q6B) as well as core analytical platforms routinely employed in a QC testing environment in order to measure them. Using a combination of lecture sessions and hands-on practical training, the course will cover methods such as electrophoretic separations (capillary electrophoresis, slab gels), HPLC/UPLC methods (peptide mapping, SEC, etc), nanoDSF (label-free nanoscale Differential Scanning Fluorimetry) and immunoassays (ELISA).

We would like to thank NanoTemper Technologies for the provision of their label-free nanoscale Differential Scanning Fluorimetry instrument, Prometheus NT. 48, for this training course. Click here to find out more about Nanotemper Techologies.

 

Navigating QC Testing for Biologics and Biosimilars

SKU: navigating-qc-testing-for-biologics-and-biosimilars Category:

2,250.00

Clear
Dates:
  • 15/07/2019 - 17/07/2019

    Out of stock

  • 02/10/2019 - 04/10/2019

    3 Places Remaining

Fee:
€2250
Suitable for:

This course is suitable for graduates seeking to gain entry into the area of biopharma QC, those currently working in QC/QA (small molecule or large), those working in product or process development/characterisation or anyone looking to increase and expand their understanding of QC testing for biologics and biosimilars.

Who should attend

This course is suitable for graduates seeking to gain entry into the area of biopharma QC, those currently working in QC/QA (small molecule or large), those working in product or process development/characterisation or anyone looking to increase and expand their understanding of QC testing for biologics and biosimilars.

Key topics covered

  • Specifications and acceptance criteria for biotech products (ICH Q6B), including critical quality attributes
  • Electrophoretic separations (capillary electrophoresis, slab gels)
  • HPLC/UPLC methods (peptide mapping, SEC, etc)
  • Protein stability screening (nanoDSF)
  • Immunoassays (ELISA)

 

Learning outcomes

Upon successful completion of this course you will be able to:

  1. Describe the critical quality attributes of biopharmaceuticals
  2. Outline and evaluate the main quality control assays/tests methods routinely employed in the analysis of biopharmaceuticals.
  3. Outline and evaluate the equipment requirements for performance of the various test methods.
  4. Interpret and critically evaluate the data and results obtained from the various practicals and demonstrations.

Assessment

A competency based assessment will be taken at the end of the course. This will certify proficiency in the theory and practical skills.

 

 

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