Biopharmaceutical plant overview

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Bio-Pharmaceutical Plant Overview



Cell Cultivation

Separation & Recovery

Purification

Crystallization & Drying

Formulation

Media

Fermented Broth

Clarified Broth

Liquid Product (API)

Product Crystals

Drug



Cell

Media

Extracellular(Product Out)

Intercellular(Product Within)



Vial

Pre-Culture

Seed Bio-Reactor

Bio-Reactor

Media


Bio-Pharmaceutical Plant OverviewCell 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


Bio-Pharmaceutical Plant OverviewSeparation

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



Heatingo Plant Steam

o Clean Steam

o Hot Water

o Hot Oil

Coolingo Cooling Water

o Chilled Water

o Brine

UtilitiesProcessing

o Water for Injection

(WFI)

o Clean Air

Controlling o Instrument Air

Miscellaneous o Electricity

o Fire Safety Water


Bio-Pharmaceutical Plant OverviewPlant Facilities

Bio-Pharmaceutical PlantProcess Facilities

Fermentation, Centrifugation, Filtration, Transportation, Chromatography, etc.

Buffer Solution Preparation Facility

Microbes Preservation Facility

Media SolutionPreparation Facility

CIP / SIPFacility

Auxiliary ChemicalsFacility

UtilitiesFacility

HVACFacility

Waste Treatment Facility

Drug PackagingFacility

Quality LabFacility

MaintenanceFacility

SafetyFacility


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Biopharmaceutical plant overview

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