Quality by Design

Question 1

What is quality by testing?

Answer 1

Quality by testing is the current system that industry use to check the quality of biopharmaceuticals.
It involves a list of qualities the must or must not have and each parameter must be tested for in each batch. These qualities include uniformity, contaminants, host cell proteins/DNA etc.

Question 2

What’s the disadvantages with quality by testing?

Answer 2

It is data intensive and involves a lot of paperwork for researchers, industry and approval agencies. The focus is on reproducibility rather than understanding how the process works. It discourages innovation and development of new/ improved processes, which slows the industry down.

Question 3

What is quality by design?

Answer 3

This involves understanding how a manufacturing process affects cell culture, protein synthesis and product quality. A limit or range for operating conditions is set that lead to an acceptable quality.
This is mandatory for small molecules and is being slowly brought in for biopharmaceuticals, but it’s a bit more complex for them.

Question 4

What’s the advantages of quality by design?

Answer 4

It is expected that this will produce safer products, less batch-to-batch testing is required and it encourages new innovative manufacturing methods which should reduce costs and make the process more effective.

Question 5

What’s involved in the quality by design process?

Answer 5

1) Carry out a risk assessment to identify risks that could occur to the product
2) Identify critical quality attributes (CQAs)
3) Make a quality target product profile (QTPP)
4) Define how the process impacts the QTPP
5) Define acceptable limits for these parameters
6) Write up all the paperwork!

Question 6

What are critical quality attributes (CQAs)?

Answer 6

A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range or distribution to ensure the desired product quality.

Question 7

Describe some product-related CQAs.

Answer 7

Aggregation
Glycosylation
Fragmentation
Deamidation
Glycation
Denaturation
Disulfide Scrambling
Oxidation

Question 8

Describe some process-related CQAs.

Answer 8

Host cell line - Contaminants, DNA, Proteins
Impurities in raw materials - Media, Feeds, Resins, Plastics
Impurities in Bioprocessing - Viruses, Microbial cells, Endotoxins

Question 9

Describe 2 Case Study papers

Answer 9

Read the damn papers Becky…..