BPE-33303 Quality by Design for Biopharmaceuticals

Course

Credits 3.00

Teaching methodContact hours
Lectures16
Project learning5
Tutorial4
Course coordinator(s)dr. ir. DE Martens
Lecturer(s)dr. M Streefland
Examiner(s)dr. M Streefland

Language of instruction:

English

Assumed knowledge on:

BPE-20806 Separation Process Design; FHM-31806 Biotechnology 2.

Contents:

Pharmaceutical biotech products are essentially different from any other biotech product in the sense that it is a high value product with very specific traits in terms of safety and efficacy, in short product quality.
Biopharmaceutical process engineers require skills in how to manage process variance and subsequently variance in product quality while being in compliance with (GMP) regulations. This course will cover the basics of regulation, manufacturing quality systems and process analytics used in modern biopharmaceutical development.

Learning outcomes:

After successful completion of this course students are expected to be able to:
- explain the relationship between process variance and product quality;
- explain how variance in raw materials, process setpoints, process performance and biological assays contribute to variation in product quality;
- apply a control strategy on variance in product quality;
- apply typical PAT tools in a process design and explain how they work to monitor bioprocesses;
- understand the principles of process quality systems;
- calculate process performance and capability indices using simple mathematics;
- interpret the outcomes of standard risk assessment methods;
perform a risk assessment on a standard biopharma unit operation;
- design an experimental plan for exploration of a process design space for a standard biopharma unit operation;
- design a study plan for the applicaton of QbD, including the use of PAT tools, for a biopharma manufacturing process;
- evaluate the results of multivariate data analysis (MVDA) on bioprocess data;
- apply multivariate data analysis on a simple dataset.

Activities:

Lectures and guest lectures (C), working classes (SW), case study (PJ).

Examination:

Presentation and written report of the outcomes of the case study (20%), written exam (80%); both marks should be at least 5.5

Literature:

Lecture slides and notes, sample excercises, scientific papers (handed out at the beginning of the course).

ProgrammePhaseSpecializationPeriod
Restricted Optional for: MBTBiotechnologyMScA: Cellular/Molecular Biotechnology3AF
MBTBiotechnologyMScD: Process Technology3AF
MBTBiotechnologyMScC: Medical Biotechnology3AF