Outstanding Clinical Biologics Manufacturing Capacity

1
Outstanding Clinical Biologics Manufacturing
Capacity
We at GenScript Probio commit to provide end to
end one stop Clinical Biologics Manufacturing
services.
2
ProMFG Service Highlights

• Comprehensive technology transfer Process
• Fully Single-Use System
• Zero-Crossover Production Lines
• cGMP Quality System

3
Comprehensive Technology Transfer Process

• Comprehensive and refined technology transfer
  process, including transfer in and out
• Parameter conversion model for mainstream
  equipment's
• Comprehensive risk control system based on FMEA
  model
• Complete the entire technology transfer process
  in only 2 months

4
Fully Single-Use System

• Cytiva XDR 200L/500L
• Thermo Fisher HyPerforma 200L/500L
• ÄKTA Ready
• Merck Mobius single-use filtration skids

5
Zero-crossover Unidirectional-flow Product Lines

• 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)

6
Contact Us
Tel [phone](Toll-Free)
Fax [phone] Email cdmo.us_at_genscript.co
m Address 860 Centennial Ave. Piscataway NJ
08854 Web www.genscriptprobio.com