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Quality Management in Pharma and Biotech. Module 4 - Quality and Safety for the Manufacturing of Biopharmaceuticals


Admission requirements

Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report, and Oral presentation. Only available to students of the Industrial Pharmacy specialisation. The course GMP voor het Middenkader must be completed.


This three-day training provides insight into the development of biopharmaceuticals and how this relates to quality aspects. We will consider the critical steps of developing cell lines, upstream and downstream processes, and commercial manufacturing up to protein analysis. Stability, comparability, contamination and immunogenicity will be discussed, as they require special attention compared to API's of non-biological origin.

Course objectives

After completion of this course students will:

  • Understand how biopharmaceuticals are produced and what the differences are between small and large (biopharmaceutical) molecules, including the key process units for cell line development, upstream and downstream processing and how they impact product quality.

  • Apply critical process parameters (CPP) and critical quality attributes (CQA) for biopharmaceuticals to achieve a robust process.

  • Understand how relevant test methods are best applied and what their limitations are.

  • Understand the up-to-date information on relevant ICH guidelines and have the knowledge where to find EMA and FDA guidance for biopharmaceuticals;

  • Apply the knowledge to achieve a compliant QP release of biopharmaceutical products according to the appropriate expectations.


This course is offered by PCS on November 21-23 in Van Der Valk Vianen.

Mode of instruction

Lectures, self-tuition, discussion.

Assessment method

This course will be concluded by a written exam and an assignment. Each counting for 50% of the final grade.

For each individual exam, the grade is expressed by using a decimal integer between 1.0 and 10.0 that should be ≥ 5.5. The final grade is expressed using an integer between 1 and 10 and can be rounded off/up to a half integer, with the exception of the grade 5.5. Final grades between 5.50 and 5.99 will be rounded up to 6.0. The final grade should be 5.5 to successfully complete this course.

Reading list

Will be announced during the course.


Enrollment via My StudyMap is not necessary for this course. Students need to enroll via the website of PCS (contact the coordinator of the specialisation for questions).


Coordinator of the specialisation Industrial Pharmacy: Drs. Judith Mathijssen,


This course is only available for students of the Industrial Pharmacy specialisation.

This information is without prejudice. Alterations can be made for next year.