Quality by Design for BiopharmaceuticalsBPE-33303

Course Outline

Dr. Mathieu Streefland

Welcome!

Why are you here?

What will we do?

What will you learn?

What will I learn?

Why are you here?

What will we do?

Week 1:

●Lectures by me

Week 2:

●Crash course on multivariate statistics by Ton van Boxtel + computer practical

●Guest lectures by speakers from industry

Week 3:

●Case study: QbD for biosimilar EPO

What will we do?Week 1: Lectures

Covers the entire book and highlights key issues for the exam

The book + PP slides + handout literature = exam theory

●Especially the case studies in the book provide a rich source of exam questions

NOT mandatory: please only join if you’re really interested

What will we do?Week 1: Lectures Monday

● Introduction biopharmaceuticals and GMP regulation● Introduction to QbD ● Ch 1+2

Tuesday● What is Quality?● New trends in the biopharma field● QbD regulatory aspects (BB literature: ICH Q8)● Ch 4, 9, 10 (case study FMEA)

Wednesday● Home study

Thursday● CQA’s and CPP’s● Risk Assessment● DoE and Process Design space● Ch 5 + 7 (example) + 11 (read only)

Friday● PAT and QbD ● Ch 12 and 13

The bookWhat’s in the exam?

Chapter 1 – complete Chapter 2 – complete Chapter 4 – complete

● Especially examples of criticality determination

Chapter 5 – Complete Chapter 7 – Background to Ch.5 Chapter 9 – Background example to Ch. 4 Chapter 10 – Background example to Ch. 4 (FMEA) and 5

● Know what issues arise during formulation of drugs

Chapter 11 – Read once to understand importance of raw materials Chapter 12 – Complete except 12.8 (12.7 will be covered by Ton) Chapter 13 – Complete: Very important chapter/summary

What will we do?Week 2

Multivariate data analysis (MVDA)

●Lecture (Ton van Boxtel)

●MANDATORY Computer practical (Ton van Boxtel)

Guest lectures

●Dr. Nienke Vriezen; head USP development Synthon

●Werner Gladdines, MSc; head development To-BBB

What will we do?Week 3: QbD case study on biosimilar EPO(PGO)

Similar to A-mAb case study report (BB)

4 or 5 groups

Each group will deliver a written report and a presentation for a QbD approach for a part of the process

●Input for Common Technical Document for BLA registration file (ICH M4Q – module 3, BB)

What will we doWeek 4: Exam

Group presentation is 20% of final mark

Exam is 80% of final mark, minimum 5.5 to pass

Exam will focus both on practical examples (case studies), and on background theory from the book

●No exact numbers, dates, definitions

●No complex calculations

What will you learn?

The book

Lecture notes

Computer practical

PGO case study

You will learn what’s necessary to design a biopharmaceutical manufacturing process that’s up to 21st century standards

What will I learn

Please give me feedback if you think I’m

●Boring

●Too fast

●Too slow

●Obnoxious

●Rude

●Over-confident

●Just an excellent teacher

●Lecturing with my fly open

What will I learn

Please give me feedback on the course

●Too many lectures?

●Do think you learn enough?

●Does the course help you pass the exam?

●Is it too busy? Not busy enough?

●Did you like the group work?

●What can be improved and how?

●Did you like it?

Mathieu.Streefland@WUR.nl

T: +31 3174 81208

Questions?