Pharmaceutical Manufacturing Flashcards
What are the 8 stages of pharmaceutical manufacturing?
- Design conception
- Process development
- Withdrawal
- Processing/production
- Refinement
- Packaging
- Delivery
- Storage
What is involved in primary processing?
Small molecules = development of API
Large molecules = development of culture/fermentation/purification
What is involved in minor/secondary processing?
Conversion of API into dosage form.
What are the 4 stages of processing/production in pharmaceutical manufacturing?
- Synthesis (small flasks -> small -> large bioreactor)
- Purification
- Formulation
- Final dosage form preparation
What is the difference between upstream & downstream processing?
Upstream - cell cultivation inc. agar plate, flask, inoculum, bioreactor to harvest of cells
Downstream - extraction/separation from biomass inc. centrifugation, precipitation/L-L extraction (Low res), chromatography (high res) - purification
What is heat flow calorimetry?
Estimates heat capacity, reaction rate & heat transfer coefficients.
What is the benefits of simulation?
Understand effects of heat transfer, scale performance limitations, controller design & selection inc operating conditions.
What are the benefits of continuous manufacturing?
Improves;
- Scalability
- Time to market
- Capital costs
- Safety
- Materials
- FDA quality
What processes are involved in continuous manufacturing?
- Blending
- Wet granulation
- Drying
- Milling
- Blending
- Compression
- Coating
What is the biggest issue with continuous manufacturing?
Manufacturer hesitation.
Define batch manufacturing.
All materials charged before start of processing & discharged at the end.
Define continuous manufacturing.
Material is simultaneously charged & discharged from process.
What is the FDA and what are the regulatory definitions of batch and lot?
Batch - Analysing & controlling manufacturing in timely measurements of quality & performance of raw & in-process materials.
Lot (continuous) - a specific amount produced in a unit of time having uniform character & quality within specified limits.
What is PAT?
Process Analytical Technology - designs, analyses & controls manufacturing in timely measurements of quality & performance.
What area is the most difficult area of process development? What is the preferred method?
Protein purification.
Chromatographic method-affinity chromatography.
