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ProMFG Clinical Manufacturing Services

Comprehensive and refined technology transfer process

Zero-Crossover with Unidirectional Flow

GenScript ProBio owns three segregated large-scale cell culture GMP upstream production lines, with a total culture volume of 2,200L (including 6x200L and 2x500L of disposable bioreactor systems); Two segregated downstream purification production lines.

GenScript ProBio GMP factory has strict physical isolation rules so that multiple samples can be produced simultaneously. The whole process, including solution preparation, cell culture, downstream chromatography and filtration, adopts single-use technology that effectively avoids the risk of cross-contamination. In addition, the GenScript ProBio Technology Transfer Team has established a comprehensive and refined technology transfer process and has implemented comprehensive risk control in the technology transfer process, which ensures the smooth transfer of customer projects and the successful completion of landing production.

Service Highlights

Technology Transfer
  • Comprehensive and refined technology transfer process
  • Parameter conversion model for different equipment (bioreactor, chromatograph)
  • Comprehensive risk management and control

Fully Disposable System
  • Cytiva XDR 200L/500L
  • Thermo Fisher HyPerforma 200L/500L
  • 10mm ÄKTA Ready
  • Merck Mobius single-use filtration skids

Zero-Crossover Production Lines
  • Unidirection flow design
  • Physical isolation of production lines

cGMP Quality System
  • Comply with the regulations of US and China
Technology Transfer
  • A technology transfer program is not just a process, it is a project
  • The key point of technology transfer is to ensure the quality and performance of biological products
  • Provides assurance that product and process knowledge from SU to RU is fully understood and properly communicated

Figure1. PDA TR65 Tech Transfer

Fully Disposable System
  • Disposable System with 80 Batches Max Capacity

    • Three Segregated Upstream Production Lines
    • Line 1:
      Cytiva XDR200L×2 + Cytiva XDR500L×1
    • Line 2:
      HyPerforma 200L×2
    • Line 3:
      HyPerforma 200L×2 + HyPerforma 500L×1
  • Two Segregated Downstream Production Lines
  • Line 1:
    AKTA Ready 10mm×2 + Mobius single-use filtration skids×1

    +       
  • Line 2:
    AKTA process 10mm×2 + Semi-automatic filtration system×1
  • QC Laboratory
Zero-Crossover Production Lines
  •   Physical Segregation for Each Production Line
    • Fully closed system & process
    • Independent Heating, Ventilation and Air Conditioning (HVAC) system
  •   Clean Utility Meeting Global Standards
    • American Society of Mechanical Engineers Bioprocessing Equipment (ASME BPE) standard
    • Chinese Pharmacopeia (CP), U.S. Pharmacopeia (USP) & European Pharmacopeia (EP) requirement
  •   Unidirectional Flow
    • Material, personnel, waste and cleaning flow
  •   Automation System
    • Environment Management System/Building Management System (EMS/BMS)
200L GMP Clinical Manufacturing Services
Milestones Content Delivery standard
Analytical method transfer and validation In process control and release test transfer and verification /
Cell line transfer and testing MCB & WCB transfer
Mycoplasma and sterility test		 /
Process transfer and validation Cell culture & purification process transfer
3/10L engineering run		 The process and product meet the quality requirements
Material purchasing and release test Material purchasing
Release test of raw materials per client's internal control standard
Release test of excipient and packaging materials per pharmacopoeia or client's standards		 /
GMP documentation preparation for drug substance production Prepare GMP Documentation including process instructtion, SOP, BPR and training records Comply with relative requirements of GMP documentation system
200L-scale GMP manufacturing of drug substance 1 batch 200L-scale GMP manufacturing of drug substance Production in compliance with GMP quality management regulation, sample passed all the required QC tests.
Drug substance release test Drug substance release test Complete release test according to GMP requirement
GMP documentation preparation for fill and finish Prepare GMP Documentation including process instructtion, SOP, BPR and training records Comply with relative requirements of GMP documentation system
Fill and finish 1 batch of fill and finish (vials) Production compliance to GMP, and samples are meet quality requirements.
Drug product release test Drug product release test Complete release test according to GMP requirement
500L GMP Clinical Manufacturing Services
Milestones Content Delivery standard
Analytical method transfer and validation In process control and release test transfer and verification /
Cell line transfer and testing MCB & WCB transfer
Mycoplasma and sterility test		 /
Process transfer and validation Cell culture & purification process transfer
3/10L engineering run		 The process and product meet the quality requirements
50L Qualification run 1 batch of 50L qualification run
Material purchasing and release test Material purchasing
Release test of raw materials per client's internal control standard
Release test of excipient and packaging materials per pharmacopoeia or client's standards		 /
GMP documentation preparation for drug substance production Prepare GMP Documentation including process instructtion, SOP, BPR and training records Comply with relative requirements of GMP documentation system
500L-scale GMP manufacturing of drug substance 1 batch 500L-scale GMP manufacturing of drug substance Production in compliance with GMP quality management regulation, sample passed all the required QC tests.
Drug substance release test Drug substance release test Complete release test according to GMP requirement
GMP documentation preparation for fill and finish Prepare GMP Documentation including process instructtion, SOP, BPR and training records Comply with relative requirements of GMP documentation system
Fill and finish 1 batch of fill and finish (vials) Production compliance to GMP, and samples are meet quality requirements.
Drug product release test Drug product release test Complete release test according to GMP requirement