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Outstanding Clinical Biologics Manufacturing Capacity

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Outstanding Clinical Biologics Manufacturing Capacity

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  1. Outstanding Clinical Biologics Manufacturing Capacity We at GenScriptProbio 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 HyPerforma200L/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: +1-732-885-9188 / +1-877-436-7274(Toll-Free) Fax: +1-732-210-0262 Email: cdmo.us@genscript.com Address: 860 Centennial Ave. Piscataway NJ 08854 Web: www.genscriptprobio.com

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