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ProMFG GMP Manufacturing Service

Support 200L to 2000L cGMP manufacturing

Tech-transfer takes 2 months only

Comply with NMPA, FDA, EMA GMP regulations

GMPOutstanding Biologics cGMP 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 (including but not limited to antibody production, protein production, etc.).

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./p>

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.

ProMFG Service Highlights

Comprehensive technology
transfer Process

Fully Single-Use
System

Zero-Crossover
Production Lines

cGMP Quality
System

GMP Drug Substance cGMP Center

Manufacturing Center, Nanjing, 2600L

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

Manufacturing Center, Zhenjiang, 16000L

LEPURE

Phase 1a:
2 x 2000L

Sartorius

Phase 1b:
6 x 2000L

Comprehensive Technology Transfer Process

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

cGMP Quality System

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

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

GMP Manufacturing Service Milestones and Delivery Standard

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
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

Manufacturing Center, Nanjing