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PHAM02 > Wk 18: Antibodies (formulation + manufacturing) > Flashcards

Wk 18: Antibodies (formulation + manufacturing) Flashcards

1
Q

What are the benefits of concentrated formulations?

A
  • Greater dose flexibility
  • Less storage space
  • Red transport cost
  • Low prod cost
  • Small vol (sc/iv)
  • Reconstituted as IV infusion
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2
Q

What are the limitations of concentrated formulations?

A
  • Processability
  • Loss of yield due to dead volume
  • Inc cost (greater overfilled vol)
  • Appearance issue
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3
Q

What does it mean if a liquid is concentrated?

A
  • Inc inter-molecular proximity
  • Inc protein-protein interactions
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4
Q

What are the issues encountered when concentrating biomolecules?

A
  • Molecular crowding
  • Stability issues
  • Viscosity issues
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5
Q

What are the techniques to concentrate solution?

A
  • Tangential flow filtration or cross flow filtration
  • Pressure driven separation technique
  • Ultrafiltration membrane or hollow fiber
  • Diafiltration
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6
Q

What are the losses encountered when undergoing tangential flow filtration?

A
  • Micro-cavitation
  • Air/liquid interface
  • High protein conc
  • Process temp
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7
Q

What destabilises unprotected protein/peptide drugs in lyophilisation?

A
  • Low temp + freezing stresses
  • Drying stresses
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8
Q

What is used to protect protein/peptide drugs from destabilising during lyophilisation?

A
  • Optimise lyophilisation cycle: avoid product collapse/melt back, adjust chamber pressure + set below critical temp
  • Add excipients
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9
Q

What are lyophilised formulation made up of?

A
  • Buffering agent: citrate
  • Bulking agent (mechanical support): mannitol
  • Stabiliser (protect against freezing/drying)
  • Tonicity modifiers
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10
Q

What are examples of stabilisers used in the lyophilised formulation?

A
  • Cryoprotectants: against freezing
  • Lyoprotectants: against drying
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11
Q

What are the mechanism of cryoprotection?

A
  • Preferential interaction (hydration at protein/peptide surface)
  • Inc viscosity
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12
Q

What are the mechanisms of lyoprotection?

A
  • Water replacement hypothesis
  • Forming amorphous glassy state
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13
Q

What are the packaging aspects of lyophilised formulations that you need to consider?

A
  • Container: prevent adsorption, type I borosilicate glass, 20-50% filled
  • Stopper: prevent moisture/permeation, butyl/halobutyl rubber
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14
Q

What are the quality checks for moisture content in lyophilised formulations?

A
  • Loss on drying
  • Karl fischer titration
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15
Q

What are the quality checks for protein bioactivity in lyophilised formulations?

A
  • Cell culture
  • Animal model
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16
Q

What are the quality checks for stability tests in lyophilised formulations?

A

Infrared/raman spectroscopy

PHAM02 (35 decks)

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