Biopharmaceutical plant overview

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Biopharmaceutical plant overview

  1. 1. Koncept Learning Center klcenter@gmail.com Bio-Pharmaceutical Plant Overview
  2. 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. 3. Koncept Learning Center klcenter@gmail.com Bio-Pharmaceutical Plant Overview Cell Media Extracellular (Product Out) Intercellular (Product Within)
  4. 4. Koncept Learning Center klcenter@gmail.com Bio-Pharmaceutical Plant Overview Vial Pre- Culture Seed Bio-Reactor Bio-Reactor Media
  5. 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. 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. 7. Koncept Learning Center klcenter@gmail.com Bio-Pharmaceutical Plant Overview
  8. 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. 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. 10. Koncept Learning Center klcenter@gmail.com For Training Workshop Write us at : klcenter@gmail.com Bio-Pharmaceutical Plant Overview

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