Course Descriptor

This 3.5 day course guides trainees through the Critical Quality Attributes 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 online followed by hands-on practical training, the course will cover methods such as electrophoretic separations (capillary electrophoresis, slab gels), HPLC/UPLC methods (peptide mapping, SEC, etc), and immuonassays (ELISA).

Course delivery method:  Blended online and onsite training

  • Three mornings online theory
  • Two days NIBRT practicals

Course Costs:

  • Three mornings online theory only: €1,425
  • Full course of Three mornings online theory and Two days NIBRT practicals: €3,325

 

April Delivery
Online Theory – 17th , 18th & 19th   
Full course – 17th , 18th & 19th  (online theory) + 25th & 26th (onsite practicals)

September Delivery
Online Theory – 04th , 05th & 06th   
Full course – 04th , 05th & 06th  (online theory) + 11th & 12th (onsite practicals)

Navigating QC Testing for Biologics and Biosimilars

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

1,425.003,325.00

Dates:
  • 17/04/2023 - 26/04/2023

    2 Places Remaining

  • 17/04/2023 - 19/04/2023

    2 Places Remaining

Fee:
€1425
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 Estimation (A280)
  • 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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