GMP mRNA & LNP

End-to-end Solution Provider for mRNA-LNP

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Overview

PackGene and Kudo Bioworks offer a one-stop platform for GMP mRNA and LNP by providing plasmid production, mRNA synthesis, Lipid Nanoparticle(LNP) encapsulation, formulation development, IND filing assistance, fill and finish, and complete documentation. We prioritize regulatory compliance and provide a quality management system that is fully compliant with regulatory standards. We offer customized process development for DNA templates, mRNA drug substances, and drug products to optimize each project’s potential. Furthermore, our comprehensive analytical panel for plasmid, mRNA and LNP provides valuable insights that allow for customized in-process control, release testing, and stability studies. Our streamlined process ensures efficiency and reliability, while our regulatory-compliant QMS and comprehensive analytical approaches ensure superior quality that exceeds industry standards. With both PD and cGMP facilities in operation, we offer a seamless transition from development to manufacturing, delivering unparalleled expertise, professionalism, and convenience in mRNA and LNP production.

What We Offer

GMP Plasmid

GMP mRNA

Lipid Nanoparticles

Excellent performance and track record

Our commitment to product quality has resulted in achieving a world-class standard that is comparable to the industry’s renowned CDMO products for mRNA and LNP. Our rigorous quality control processes and comprehensive analytical testing ensure that our products meet and exceed the highest global standards. Trust us to deliver outstanding results for your drug development project.

One Stop Shop

For all your mRNA manufacturing needs. Our streamlined process ensures ease in your CMC

Performance

Speed

Quality

Full compliance with global regulatory requirements

*Quality specifications are for a typical linear mRNA, 3-5 Kbp.

Plasmid cGMP Manufacturing Site

1,300 sqf PD room
11,000 sqf GMP room

5L to 200L fermenters
Batch sizes of up to ~100g

PackGene’s state-of-the-art GMP plasmid production site located in Guangzhou, China, and is dedicated to providing reliable, compliant, and scalable plasmid production services. With a team of ~40 staff members, including management staff members with over 15 years of experience and over 7 years of AAV and plasmid prep experience. The site and staff ensure that reliable materials are generated for the production of high-quality mRNA, and our team takes shifts to ensure continuous production without interruption.

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

57,000 sqf lab
3 mRNA lines, 2 LNP bulk lines, and 1 drug product fill & finish line

Capacity of 40 million vials/year
Preclinical through commercial manufacturing

Kudo Bioworks, Shanghai, China

mRNA PD lab

5,500 sqf lab
North American PD lab to efficiently support US/EU clients

Kudo Bioworks has a 57,000 square feet facility in Minhang, Shanghai, designed and constructed in compliance with cGMP and global regulatory guidelines. Our facility accommodates 3 mRNA lines, 2 LNP bulk lines, and 1 drug product fill & finish line. Our production lines fulfill manufacturing needs for preclinical studies through Phase 2 clinical trials, and our facility architecture has the capacity to manufacture up to 40 million vials/year, accommodating scales necessary for Phase 3 trials and commercial manufacturing.

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

GMP mRNA Production Process

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.

Comprehensive Analytical Panel

Our comprehensive analytical panel allows for customized in-process control, release testing, and stability studies for plasmid, mRNA, and LNP. This enables us to tailor our approach to meet the specific needs of your project and ensure that the final product is of the highest quality.

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

With our advanced analytical tools, we monitor every step of the production process to identify any potential issues early. This allows us to take corrective action quickly and efficiently when necessary. Our commitment to using the latest analytical techniques means that you can have confidence in the accuracy and reliability of our testing methods.

Project Timeline

Activities

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

non-GMP batch, 4 months

GMP batch, 6.5 months

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

Our Quality Management System is designed to ensure that every aspect of the product quality realization process is carefully monitored and controlled. This includes personnel, facilities and equipment, environment, materials, manufacturing, QC, and product release. We also employ validation and qualification protocols to ensure that our products meet the highest standards of quality. In addition, our quality assurance program includes change control, deviation handling, complaint handling, quality management review, recall procedures, internal audits, and corrective and preventive action planning, all guided by our quality risk management framework. Finally, all of our processes are thoroughly documented to ensure transparency and traceability, providing you with the confidence that your product is of the highest quality.

Our commitment to quality is at the heart of everything we do. Our Quality Management System is a comprehensive framework that ensures every step of our process is carefully planned, executed, and monitored to meet the highest standards.

Documentation In Real Life

Comprehensive documentation is essential to ensure regulatory compliance and product quality. At our facility, we provide extensive documentation covering all aspects of the drug development process, including project management, operation procedures, and quality control. This documentation is meticulously maintained throughout the entire lifecycle of the drug, from R&D, to clinical trials, and commercialization.

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