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ProMFG Clinical Manufacturing Services

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Tech-transfer in 2 months only

Comply with US and China GMP regulations

Outstanding Clinical Biologics Manufacturing Capacity

GenScript Probio is the world's leading CDMO platform, committing to providing global biopharma and biotech companies with end-to-end, one-stop professional services from drug discovery to GMP Biologics manufacturing manufacturing.

Our GMP production center follows the internationally leading design concept and is a true "zero-crossover, unidirectional flow" plant, which meets global regulatory requirements. Strict physical isolation measures are adopted in the whole workshop, which ensure production of multiple samples at the same time.

GenScript Probio now owns 3 independent large-scale cell culture GMP upstream production lines with a total culture volume of 2,200L (including 200L and 500L disposable bioreactors); and 2 independent downstream purification production lines.

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 successful production.

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ProMFG Service Highlights

  • 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
    • Comply with the US / EU / China regulatory requirements for clinical sample production
    • Comprehensive quality management system
    • Experienced quality management team
  • cGMP Quality System
Milestones Content Delivery standard
Analytical method transfer and validation In process control and release test method 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
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 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 passes 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 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 requirement
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
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 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