Biosimilars

Question 1

what is meant by pharming

Answer 1

use of genetic engineering to make therapeutics. Eg
- vaccine antigens
insulin
growth hormones

Question 2

what are the requirements in mass production

Answer 2

must have
1. clean rooms
2. sterile or virus segregation equipment
3. segregation of personnel

Question 3

outline the process of mass production

Answer 3

1. cell line development
2. cell expansion
3. cell culture
4. harvest
5. purification
6. virus inactivation or removal
7. filling
8. finishing
9. packaging
10. quality assurance
11. stability

Question 4

what are the basic elements of the clean up process

Answer 4

1. cell disruption- mechanical, chemical, enzymatic, antibiotic
2. removal of insolubles- filtration, centrifugation
3. product isolation- removal of less valuable components
4. product purification- affinity, size exclusion, crystallisation
5. product completion- sterilisation and removal of viruses or depyrogenation

Question 5

what does human serum albumin need in process chromatography

Answer 5

1. flocculation of solids, ionic strength modification and flocculant
2. pH modification for selective precipitation of protein fractions
3. size exclusion chromatography
4. gel permeation chromatography
5. ion exchange chromatography

Question 6

what can biologics be composed of

Answer 6

sugars, proteins, DNA fragments or complex combinations of these substances, or may be living entities such as cells and tissues

Question 7

give examples of routine biologicals control of quality

Answer 7

1. melting point or glass transition- indicates purity, water content
2. optical density- indicates particulates, denaturation

Question 8

what are the 3 categories in control of quality

Answer 8

1. biological potency
   - in vitro, in vivo, impurity
2. microbiological science
   - pathogens, process indicators, pyrogens
3. analytical science
   - ELISA, electrophoresis, microscopy

Question 9

what are the problems with biologicals

Answer 9

1. consistency of biological material- risk of variability
2. uniformity from batch to batch
3. non inert growth medium
4. potency

Question 10

what is meant by lean manufacturing within industrial biotechnology

Answer 10

1. developed to provide a less wasteful type of production
2. commonly uses the following tools: new concepts, just-in-time, value stream mapping, total production maintenance
3. helps reduce costs of production of biologicals

Question 11

what are the risks with lean manufacturing

Answer 11

risks associated with any form of reduced testing or the idea of restricted process monitoring

Question 12

what is the role of the qualified person on biologicals and quality assurance streams

Answer 12

1. directives, guidelines to cGMP/GLP followed
2. validation
3. checks of production conditions
4. MHRA/FDA approval

Question 13

what is an internal form of regulation

Answer 13

quality assurance and validation