![icon 12](https://www.packgene.com/wp-content/uploads/2023/08/icon-12-1.png)
PackGene is excited to announce the launch of innovative mRNA products & services that are designed to streamline your research. From now until May 30, enjoy an exclusive 30% discount on our most recent developments.
Terms and conditions:
PackGene Biotech Inc. reserves all rights to this promotion. Promotion limited to North America, Europe and Asian Pacific except China. Valid for off the shelf mRNA and LNP, and gene editing mRNA fast service orders placed between Apr2nd. to May 30th only and cannot be applied to existing orders.
Coupon Code: mRNA30off24
Questions? Please contact info@packgene.com
Excellent performance and track record
One Stop Shop
For all your mRNA manufacturing needs. Our streamlined process ensures ease in your CMC
![Performance of PackGene‘s GMP mRNA One Stop Shop Performance of PackGene‘s GMP mRNA One Stop Shop](https://www.packgene.com/wp-content/uploads/2023/05/Performance-of-PackGene‘s-GMP-mRNA-One-Stop-Shop.jpg)
![Speed of PackGene‘s GMP mRNA One Stop Shop Speed of PackGene‘s GMP mRNA One Stop Shop](https://www.packgene.com/wp-content/uploads/2023/05/Speed-of-PackGene‘s-GMP-mRNA-One-Stop-Shop-2.jpg)
![Quality of PackGene‘s GMP mRNA One Stop Shop Quality of PackGene‘s GMP mRNA One Stop Shop](https://www.packgene.com/wp-content/uploads/2023/05/Quality-of-PackGene‘s-GMP-mRNA-One-Stop-Shop-1.jpg)
Full compliance with global regulatory requirements
*Quality specifications are for a typical linear mRNA, 3-5 Kbp.
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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
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- 5,500 sqf lab
- North American PD lab to efficiently support US/EU clients
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Kudo Biotechnology 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.
![GMP mRNA production process GMP mRNA production process](https://www.packgene.com/wp-content/uploads/2023/05/GMP-mRNA-production-process.jpg)
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
![Comprehensive analytical panel Comprehensive analytical panel](https://www.packgene.com/wp-content/uploads/2023/05/Comprehensive-analytical-panel.jpg)
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 | ![]() |
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Engineering (non-GMP) batch & release | ||||||||||||||
Analytical methods Validation | ||||||||||||||
GMP batch | ![]() |
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GMP batch release | ||||||||||||||
Total excl. tax |
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Quality Management System
![Quality management system Quality management system](https://www.packgene.com/wp-content/uploads/2023/05/Quality-management-system.jpg)
![icon 21](https://www.packgene.com/wp-content/uploads/2023/08/icon-21-1.png)
Project Document
- Enquiry Assessment
- Manufacture Summary
- Packaging Summary
- Delivery Summary
- Agreement and Contract
![icon 22](https://www.packgene.com/wp-content/uploads/2023/08/icon-22-1.png)
Operation Document
- SOPs
- Goods Receiving Record
- Work Order
- Batch Record
- Shipping Request
- Distribution Record
- Logbook
- Environment Monitor
![icon 20](https://www.packgene.com/wp-content/uploads/2023/08/icon-20-1.png)
Quality Document
- Specification
- Material and Product Test
- CoA
- Batch Record Review and Release
- Stability Data
- Validation Report
- Supplier Qualification