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Biopharmaceutical
Process Development

for recombinant protein production
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Points to consider in developing a biopharmaceutical process include: protein purity, scale-up requirements, yield, practical manufacturability and overall cost.
A typical process development protocol for recombinant protein includes:
 
1. Optimization of Expression Systems
  • choice of vector
  • choice of cell line and clonal selections
2. Optimization of Cell Culture Conditions
  • available media and supplements
  • growth parameters including pH, temperature, O2, CO2, etc.
3. Development of a purification SOP
  • choice of chromatography steps
  • Endotoxin removal
  • virus inactivation and clearance

PROCESS DEVELOPMENT
TIME & COST LINE
Months 1
Development of
Cell Line
MCB/WCB		 2

Optimization
Growth
Parameters		 3

Laboratory
Scale
Fermentation		 4


Pilot Scale
Fermentation		 5


Purification &
Characterization		 Costs

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Process Development
 
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Recombinant Protein
 
Process
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Related Links
Recombinant
Protein Expression
 
Protein Purification
 
Virus Production &
Purification
 
Functional Assays &
Assay Development
  
  
  
  
 
 

Cell Culture & Fermentation Services
Recombinant Protein Expression | Protein Purification
Proteomics Services - Protein Characterization
Virus Production & Purification | Process Development
Functional Assays & Assay Development | Histology & Immunohistochemistry
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