1. Koncept Learning Center
klcenter@gmail.com
Bio-Pharmaceutical Plant
Overview

2. Koncept Learning Center
klcenter@gmail.com
Bio-Pharmaceutical Plant Overview
Cell Cultivation
Separation & Recovery
Purification
Crystallization &
Drying
Formulation
Media
Fermented Broth
Clarified Broth
Liquid Product (API)
Product Crystals
Drug

3. Koncept Learning Center
klcenter@gmail.com
Bio-Pharmaceutical Plant Overview
Cell
Media
Extracellular
(Product Out)
Intercellular
(Product Within)

4. Koncept Learning Center
klcenter@gmail.com
Bio-Pharmaceutical Plant Overview
Vial
Pre-
Culture
Seed
Bio-Reactor
Bio-Reactor
Media

5. Koncept Learning Center
klcenter@gmail.com
Bio-Pharmaceutical Plant Overview
Cell Disruption (Lysis)
 Mechanical
 Homogenizer
 Bead Mill
 Sonicator
 Non-Mechanical
o Physical
 Decompression
 Osmotic Shock
 Freeze Thaw
o Chemical
 Surfactants
 Solvents
 Antibiotics
o Enzymatic
 Autolysis
 Lytic Enzyme
 Cloned Pange Lysis
Challenges
• Damage to the Product
• Heat denaturation
• Oxidation of Product
• Unhindered release of all intracellular products

6. Koncept Learning Center
klcenter@gmail.com
Bio-Pharmaceutical Plant Overview
Separation
Fermented Broth
Insoluble
Soluble
• Cell
• Cell Debris
• Particulate Matter
• Water
• Proteins
• DNA
• Virus
• Buffer Solution
• Filtration
• Centrifugation
• Flocculation
• Sedimentation
• Liquid-Liquid Extraction
• Precipitation
• Adsorption
• Membrane Separation
• Chromatography

7. Koncept Learning Center
klcenter@gmail.com
Bio-Pharmaceutical Plant Overview

8. Koncept Learning Center
klcenter@gmail.com
Bio-Pharmaceutical Plant Overview
Heating
o Plant Steam
o Clean Steam
o Hot Water
o Hot Oil
Cooling
o Cooling Water
o Chilled Water
o Brine
Utilities
Processing
o Water for Injection (WFI)
o Clean Air
Controlling
o Instrument Air
Miscellaneous
o Electricity
o Fire Safety Water

9. Koncept Learning Center
klcenter@gmail.com
Bio-Pharmaceutical Plant Overview
Plant Facilities
Bio-Pharmaceutical Plant
Process Facilities
Fermentation, Centrifugation, Filtration, Transportation, Chromatography, etc.
Buffer Solution
Preparation Facility
Microbes
Preservation Facility
Media Solution
Preparation Facility
CIP / SIP
Facility
Auxiliary Chemicals
Facility
Utilities
Facility
HVAC
Facility
Waste
Treatment Facility
Drug Packaging
Facility
Quality Lab
Facility
Maintenance
Facility
Safety
Facility

10. Koncept Learning Center
klcenter@gmail.com
For Training Workshop
Write us at : klcenter@gmail.com
Bio-Pharmaceutical Plant Overview