L12 Biologics Flashcards
What are biologics?
Biological products, such as therapeutic proteins (Abs, enzymes), vaccines, blood/blood components, cells, tissues & gene therapy, used in the treatment of many inflammatory diseases and cancers for example
Emerging trends in biologics
- Expression system/cell types: plant cells, insect cells, viral vectors
- Products: advanced therapy medicinal products, gene therapy/RNAi, tissue engineering, personalised medicine
What is a biosimilar?
A biologic drug that’s almost an identical copy of an original that’s manufactured by a different company using a different process
Difference between small molecule drugs and biologics
Biologics generally exhibit higher molecular complexity and may be quite sensitive to changes in manufacturing processes (aseptic principles used)
Typical manufacturing process
- Cell line engineered to express product
- Cells are cultured to produce the product
- Material is harvested and put through a purification process
- Final product is tested, released & distributed to patients
Biologics tend to be __ sensitive and susceptible to __ __
heat
microbial contamination
Cells are cultured in a __
bioreactor
What are separation techniques based on?
The molecular properties of the product
A target to treat RA
TNFα (pro-inflammatory cytokine)
Another name for immunomodulators
Biologic response modifiers (BRMs)
The first biologic for RA
Infliximab (Remicade) - mAb to TNFα
mAbs to TNFα (other than Infliximab)
Adalimumab (Humira)
Golimumab (Simponi)
The only PEGylated anti-TNFα agent
Certolizumab pegol (Cimzia)
How does Certolizumab pegol differ to other anti-TNFα agents?
- It has no Fc domain
- PEG addition suppresses immunogenicity & increases drug stability by prolonging half-life
First TNFα inhibitor FDA approved for plaque psoriasis
Etanercept (Enbrel)
