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ProMFG Service Highlights

GenScript ProBio has established a complete technology transfer SMP, which enables multi-dimentional gap analysis and risk assessment in terms of personnel, equipment, material, method, environment and testing. Successful process transfer can be ensured either from clients or to clients.

  • Comprehensive and refined technology transfer process, including transfer in and out
  • Parameter conversion model for mainstream equipments
  • Comprehensive risk control system based on FMEA model
  • Complete the entire technology transfer process in only 2 months
  • Cytiva XDR 200L/500L
  • Thermo Fisher HyPerforma 200L/500L
  • ÄKTA Ready
  • Merck Mobius single-use filtration skids

    Upstream*3

    • Line 1:
      Cytiva XDR200L×2
      Cytiva XDR500L×1

    • Line 2:
      HyPerforma 200L×2

    • Line 3:
      HyPerforma 200L×2
      HyPerforma 500L×1

    Downstream*2

    • Line 1:
      ÄKTA Ready 10mm×2
      Mobius single-use filtration skids ×1

    •          
    • Line 2:
      ÄKTA process 10mm×2
      Non-disposable filtration skids ×1

  • Unidirectional-flow design including personnel, material, waste, cleaning, etc.
  • Physical segregation for each production line to achieve a fully enclosed process system.
  • Clean utility meets global standards (ASME BPE, USP / EP / ChP requirements)
  • Automation systems including environmental management system (EMS) and building management system (BMS)
  • Zero-crossover
  • Zero-crossover
  • Zero-crossover

The design and construction of ProBio’s cGMP production workshop was carried out in strick compliance with the current regulations and guidelines of China, the US and the European Union. It functions based on the quality system of highest standard and can effectively meet the requirements of global surveillance for biologics production facilities.

  • Comply with NMPA, FDA, EMA regulations
  • Comprehensive quality management system
  • Experienced quality management team
cGMP质量体系

ProBio’s quality management system strictly complies with ICH and global GMP regulations which includes 6 major sub-systems

cGMP Quality System
Milestones Content Delivery standard
Analytical method transfer and validation In process control and release test transfer and verification Analysis method is transferred according to the predetermined plan
Cell line transfer and testing MCB & WCB transfer
Mycoplasma and sterility test
Complete the transfer according to the agreed standard and time
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
Complete purchasing and releasing test according to standards
GMP documentation preparation for drug substance production Prepare GMP Documentation including process instructtion, SOP, BPR and training records Comply with requirements of GMP documentation system
GMP manufacturing of drug substance 1 batch of GMP manufacturing of drug substance Production in compliance with GMP quality management regulation
Sample passes all the required QC tests
Drug substance release test Drug substance release test Complete release test according to GMP requirements
GMP documentation preparation for fill and finish Prepare GMP Documentation including process instructtion, SOP, BPR and training records Comply with requirements of GMP documentation system
Fill and finish 1 batch of fill and finish (vials) Production in compliance with GMP quality management regulation
Sample passes all the required QC tests
Drug product release test Drug product release test Complete release test according to GMP requirements