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GMPro^TM Plasmid Manufacturing

Meet clinical trial expectations, ready for regulatory submission

Appropriate for viral vector and mRNA production

ProBio GMPro^TM Plasmid for research and development and clinical use of advanced therapy

GMPro^TM plasmid DNA is appropriate for the production of viral vectors or mRNA therapeutics. The whole process, manufacturing environment and documentation are strictly controlled under comprehensive quality assurance, guarantee the product quality and compliant for early clinical stages and research and development. We are also able to provide documentations for regulatory submissions.

ProBio is dedicated to providing one-stop solution from plasmid production to viral vector production (Lentiviral vector or AAV) to clients.

Plasmid FAST MFG. (GMPro^TM Grade)

Half of Turnaround Time

4 Weeks
Shorter Time

With High Quality
High Density Fermentation

Chromatography Purification

Expect MORE from GMPro^TM Plasmid

Speed to Clinic

Fast delivery
Support regulatory submissions

Critical Quality Assurance

Phase Appropriate Compliance (PAC)
Customer Quality Verification (CQV)
Accumulated Experience
- Over 500 manufacturing batches for clinical trials
- Various downstream applications for CGT, mRNA vaccine, DNA vaccine, etc.
- Global clients from China, USA, Korea, etc.

Product Details

High-density fermentation
Alkaline lysis
Chromatographic purification
Product release review
TSE/BSE statement
Manufacturing Summary Report
Full quality oversight

Optional:

E.coli Working Cell Banking
Stability test
Additional quality control

Quality Control Information

More assays are included except for the ones listed below, and other options are available. Get a quote for more information.

QC Item	QC Method
Appearance	Visual inspection
A260/A280	Absorbance ratio
Restriction Digest	AGE
Supercoiled Content	HPLC
Residual E. coli DNA	AGE
Residual E. coli RNA	AGE
Sequencing	Sanger
Endotoxin	LAL assay
......	......

GMPro^TM is a service trademark applied by ProBio

GMProTM Plasmid Manufacturing

ProBio GMProTM Plasmid for research and development and clinical use of advanced therapy

Plasmid FAST MFG. (GMProTM Grade)

Expect MORE from GMProTM Plasmid

Speed to Clinic

Critical Quality Assurance

Accumulated Experience

Optional:

Related Products

GMPro^TM Plasmid Manufacturing

ProBio GMPro^TM Plasmid for research and development and clinical use of advanced therapy

Plasmid FAST MFG. (GMPro^TM Grade)

Expect MORE from GMPro^TM Plasmid