Protein Manufacturing Facility - Technical Statistics

1. Scale-up Laboratories
   Cell Culture
        •   Inoculum preparation, toxicology cell bank
   Bioreactor Room
        •   1 x10L, 1 x 70L, 1 x 250L batch, fed batch and perfusion
        •   Toxicology material
   Purification
        •   Small and large scale chromatography
        •   Small and large scale ultra-filtration
   Identical equipment in Scale-Up and cGMP manufacture
        •   Allows for seamless technical transfer
        •   Minimizes operational changes
        •   Cleaning validation
   
   
2. cGMP Manufacturing
   Classification
        •   Process Suites are Class 10000 (Grade C) support areas are Class 100 000 (Grade D)
   Return Corridor
        •   Encircles all the manufacturing suites
        •   Visitors can look through viewing windows without having to enter suites
        •   Waste/dirty items exit suites into return corridor preventing cross over of clean and dirty items
   Isolation Suites
        •   3 separate suites to allow for processing of partially characterized cell lines
        •   MCB and WCB, bioreactor seed or even manufacturing
   Bioreactor Suite
        •   3 x 10L, 1 x 70L, 2 x 250L, 1 x 500L
        •   Batch, fed batch and perfusion where practically required
        •   System designed to allow maximum flexibility/utilisation of different bioreactors and bioreactor combinations on a closed system
        •   2 recovery suites with medium and large scale UF for harvest clarification
   Purification Suites
        •   2 separate purification suites for pre- and post virus processes
        •   Both with chromatography and ultra-filtration skids and dedicated cold rooms
   Final Filtration
        •   Final chromatography
        •   Final filtration and bulk aliquotting
   
   
3. Support Areas
   Microbiology/Quality Control laboratories
        •   Environmental testing
   Buffer preparation
        •   Skid with 50L, 120L, 250L and 1000L preparation vessels
   Analytical laboratories
        •   In-process assays
   Cell bank and Product Storage
        •   -20°C, -80°C, liquid and vapour phase nitrogen storage
   Clean Services
        •   Process washing machines, sterilizing autoclaves and CIP station
   
   
4. General Features
   Process Control Philosophy
        •   Individual process equipment have own PLC as necessary
        •   All critical control systems meet with CFR 21 Part 211
        •   Central Data Management System collects and store data from facility (temperature, humidity etc) and critical process equipment (incubators, freezers etc)
   Layout
        •   All laboratory areas located on ground floor, admin on first floor
        •   HVAC systems on concrete mezzanine floor above warehouse for easy maintenance access
        •   Suspended ceiling above manufacturing area
   Controlled access
        •   24 hour site security, controlled card access throughout the facility