Protein Therapeutics

Question 1

Whats a Biosimilar

Answer 1

Medecine, that is highly simmilar to another Biologic

Question 2

Name the four Proteintherapeutics classes

Answer 2

1) Enzymatic - regulatory activity a)Replacing (Insulin) b)Augmenting (EPO) c) Novel function
2) Activity a) blocking (mAb) b) Delivery of small molecules (ADC)
3) Vaccines a) Prophilactic b) therapeutic autoimune c) therapeutic cancer
4) Diagnostics (prick test)

Question 3

What is Microheterogeneiety?

Answer 3

Small impureties in the production of Biopharmaceuticals from:
Organism
Process conditions
Internal modifications
lead to variation in the product

Question 4

Name some causes for ADA

Answer 4

• Host cell impurities
• Aggregates
• Prolonged half life
• Engenered modifications

Question 5

Name four Cultivation strategies and what they mean

Answer 5

• Batch, all in all out
• Continuous waste, products and cells are withdrawn (cells constant)
• Perfusion only waste and product are withdrawn (increase in cells)
• fed-batch multiple in all out

Question 6

Compare Batch cultivation with Continuous

Answer 6

Batch:
- Controllable;clear separation easy to manage
- Low risk of contamination
- Inefficient compared to Continuous
- Accumulation of Metabolites
Continous:
- High output
- Higher risk of contamination and genetic shifts
- Less risk of aggregation