Promotion: Research Grade Catalog mRNA 50% OFF Promotion
Get twice as much catalog mRNA encapsulated in LNP


GMP Plasmid

GMP mRNA

Lipid Nanoparticles
Excellent performance and track record
One Stop Shop
For all your mRNA manufacturing needs. Our streamlined process ensures ease in your CMC



Full compliance with global regulatory requirements
*Quality specifications are for a typical linear mRNA, 3-5 Kbp.
Plasmid cGMP Manufacturing Site
|
|
Read More
The facility is equipped with fermenters ranging from 5L to 200L, enabling batch sizes of up to ~100g plasmid, with hundreds of lots produced yearly.
PackGene s plasmid production site has a 1,300 sqf PD room and a 11,000 sqf GMP room, ensuring compliance with regulatory standards. With its reliability, scalability, and compliance, the facility provides high-quality plasmid production services that exceed industry standards.
PackGene Biotech, Guangzhou, China
mRNA and LNP cGMP Manufacturing Site
|
|
Kudo Bioworks, Shanghai, China
mRNA PD lab
- 5,500 sqf lab
- North American PD lab to efficiently support US/EU clients
Read More
Kudo Bioworks is a one-stop CDMO for customers worldwide, offering Process Development, Technology Transfer, cGMP manufacturing, Fill & finish, Testing & Release, and Supply Chain Management. Our facility is equipped with cutting-edge equipment customized for mRNA, to consistently achieve high product quality. Kudo’s deployment of Remote Terminal Units prevents cross-contamination, and allows for quick response to business and production changes to meet the dynamic needs of different customers and projects.
Kudo’s Manufacturing Sciences & Analytical Technology laboratories enable the development and transfer of manufacturing technologies between our facility and external partners. These laboratories can also produce non-GMP material for early-stage preclinical and toxicology studies.
Kudo Bioworks, Boston, MA. USA

At PackGene and Kudo Bioworks, we are committed to delivering the highest quality GMP mRNA production process. Our process starts with GMP plasmid DNA manufacturing, which includes the creation of an E. coli strain cell bank, fermentation, plasmid DNA purification, and QC release to ensure that the DNA is of the highest quality.
Next, we move on to mRNA transcription and purification, where we linearize the pDNA and perform in-vitro transcription, capping, dsRNA removal, bulk purification, and QC release to ensure that the mRNA is pure and free from contaminants.
Analysis of plasmid
- Restriction Pattern
- Sequence
- Purity
- Content
- Residual Protein
- Residual DNA
- Residual RNA
- Bioburden
- Endotoxin
Analysis of mRNA
- pH
- Content
- Sequence
- Purity
- mRNA Integrity
- Capping Efficiency
- Poly A Tail Length
- Residual pDNA
- Residual Protein
- Residual NTPs
- dsRNA Content
- Residual Solvents
- Bioburden
- Endotoxin
Analysis of LNP
- pH
- Osmolality
- Encapsulation %
- mRNA Integrity
- Lipid Content
- LNP Site
- LNP Polydispersity
- Residual Solvent
- Potency
- Sterility
- Endotoxin
- Subvisible Particle
- Extractable Volume

Activities | M1 | M2 | M3 | M4 | M5 | M6 | M7 | |||||||
MCB Generation | ||||||||||||||
MCB Characterization | ||||||||||||||
WCB Generation | ||||||||||||||
WCB Characterization | ||||||||||||||
pDNA upstream process development | ||||||||||||||
pDNA downstream process development | ||||||||||||||
Set-up of analytical methods for pDNA | ||||||||||||||
RNA platform process development | ||||||||||||||
Set-up of analytical methods for RNA | ||||||||||||||
LNP-DP platform process development | ||||||||||||||
Set-up of analytical methods for LNP-DP | ![]() |
|||||||||||||
Engineering (non-GMP) batch & release | ||||||||||||||
Analytical methods Validation | ||||||||||||||
GMP batch | ![]() |
|||||||||||||
GMP batch release | ||||||||||||||
Total excl. tax |


Platform Technology Timeline: At PackGene and Kudo Bioworks, we pride ourselves on our industrial-leading timeline of 6.5 months from PCB to GMP release. This streamlined process makes us highly competitive in the market, allowing us to provide you with the highest quality GMP mRNA and LNP production in a timely and efficient manner. Trust us to deliver exceptional results, while still meeting all regulatory requirements and maintaining the highest quality standards. With our efficient timeline and commitment to excellence, we are confident that we can meet and exceed your expectations for your next project.
Quality Management System


Project Document
- Enquiry Assessment
- Manufacture Summary
- Packaging Summary
- Delivery Summary
- Agreement and Contract

Operation Document
- SOPs
- Goods Receiving Record
- Work Order
- Batch Record
- Shipping Request
- Distribution Record
- Logbook
- Environment Monitor

Quality Document
- Specification
- Material and Product Test
- CoA
- Batch Record Review and Release
- Stability Data
- Validation Report
- Supplier Qualification