ProMFG Clinical Manufacturing Services

Schedule now, no need to wait

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 technology
transfer Process

Fully Single-Use
System

Zero-Crossover
Production Lines

cGMP Quality
System

Comprehensive Technology Transfer Process

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

Fully Single-Use System

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

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)

cGMP Quality System

- Comply with the US / EU / China regulatory requirements for clinical sample production
- Comprehensive quality management system
- Experienced quality management team

200L GMP Clinical Manufacturing Services

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

500L GMP Clinical Manufacturing Services

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	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 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