WuXi Biologics offers extensive development capabilities and GMP manufacturing capacity for mRNA therapeutics and vaccines. Our expert and highly-trained team provides end-to-end services from early-stage development through to initial plasmid DNA manufacturing and on to drug substance (DS) and drug product (DP) GMP production. Our GMP services include a manufacturing facility with up to 300L scale fermenter for plasmid DNA production and 50L volume vessels and purification equipment for mRNA transcription and purification. In addition, state-of-the-art mRNA-LNP production systems and robotic aseptic filling systems are available for DP manufacturing. Like all of our services, the foundation of our mRNA service platform is built upon remarkable in-house, single-source CMC development and manufacturing capabilities and expertise, execution excellence, and our world-class quality system. TIPS: We also provide rapid material generation and high-quality feasibility study services as standalone projects.
WuXi Biologics’ services for mRNA therapeutics and vaccines
Integrated, End-to-end Services from Sequence to IND
Plasmid DNA manufacturing
E. coli strain construction
Plasmid purification
Plasmid DNA
Fermentation
In vitro transcription (Co-capping or post-capping)
mRNA transcription and purification
Key services include: Sequence optimization MCB/WCB creation and testing Process development:
Plasmid DNA linearized template
mRNA purification
mRNA DS
mRNA-LNP formulation
Sterile filtration
LNP encapsulation
TFF
mRNA-LNP
Plasmid DNA: E. coli fermentation, cell lysis and purification mRNA: In Vitro Transcription (IVT) including co-capping or post-capping, purification LNP: encapsulation, UF/DF, fill/finish
DS & DP manufacturing
Stability
mRNA DS
mRNA-LNP
Release
Tech transfer and scale-up GMP manufacturing: DS and DP Comprehensive analytical development and QC testing capability Full CMC and regulatory support
WuXi Biologics services cover all critical CMC processes with a timeline of 8 months from DNA to IND filing.
8 months from DNA to IND filing
1
2
3
4
5
6
7
8
Tox materials release
GMP pDNA release
DNA
GMP mRNA release
GMP mRNA-LNP DP release
Powered by FlippingBook