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ProBio CGT GMP Facilities
GMP Facility
Hopewell, USA | Zhenjiang, China
Stable Supply Chain
State-of-the-Art
Equipment and
Facility
Fast Turnaround
Time with No
Waiting Time
with Local Operations
and Sourcing
Resilient supply chain in the USA and China
Hopewell, USA (128,000 ft² )
Zhenjiang, China (209,000 ft²)
-1.5h to JFK in New York by car
– 1.5h to Shanghai by train
End-to-end solutions for plasmid and
viral vector production to streamline and
accelerate project timelines
Proven track record in NMPA, MFDS,
TGA, DRAP, PMDA, CCMO, Ministry of
Health and FDA
Enhanced quality through full single-use
End-to-end solutions for plasmid to
technologies
viral vector and mRNA
US-based operations and sourcing for a
stable supply chain in US & EU market, reducing
complexities
In compliance with GMP and follow ICH, FDA
and EMA Guidance
ISO 9001:2015 certiꢀcation
US-based project managers and SMEs
Separated and dedicated function areas
with unidirectional ꢁow and airlocks
within production area
for convenient communications and meetings
ISO 27001 certiꢀcation
GMP facility passed FDA’s PAI
ProBioCDMO.com
+1-732-885-9188
Accelerating Ideas. Delivering Impact.
Plasmid
94 ,000 ft² including GMP suites
Ultra small scale ( 50mg~200mg) plasmid for early-phase trial with no excess waste and overproduction
Guaranteed plasmid quantity and quality – no surprises or hidden costs
Excellent ITR integrity with proprietary PowerS™-ITRrs strain for AAV transfer plasmid
Proprietary PowerS™-PolyAssure strain guarantees poly(A) purity
High performing PowerS™-DNA+ strain for DNA vaccine
E. coli fermentation ProPlus™ process and ProSyn™ cell-free linearized DNA)
Automatic fill & finish
In-house QC: supercoiled %, residuals, endotoxin, sterility, identity, potency, etc.
Viral Vector
105,000 ft² GMP cleanroom suites AAV/LVV/RVV
Proprietary PowerS™-293/PowerS™-293T and licensed PowerA™-293T cell line
Adherent viral vector production: up to 96L
Suspension single use bioreactor: up to 200L
Cell factory/fix-bed bioreactor/single-use bioreactor
Automatic filling/capping/labelling
mRNA/saRNA/circRNA
17,000 ft² from PD to GMP
Enzymatic and co-transcriptional capping
Excellent LNP encapsulation process
Automatic filling: filling/capping