mRNA

Overview: WuXi Biologics’ services for mRNA therapeutics and vaccines

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 initial plasmid DNA manufacturing to drug substance (DS) and drug product (DP) GMP production. Our GMP facilities include a microbial-based manufacturing facility with up to 300L scale fermenter for plasmid DNA production, and multiple vessels covering a wide range of reaction volumes 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. As with all of our services, the foundation of our mRNA service platform is built upon our remarkable in-house, single-sourced CMC development and manufacturing capabilities and expertise, executional excellence, and world-class quality system.

Integrated end-to-end services from sequence to IND

Key services include:

Sequence optimization Process development:

- Plasmid DNA: E. coli fermentation, cell lysis and purification
- mRNA: In Vitro Transcription (IVT) including co-capping or post-capping options, purification
- LNP: encapsulation, UF/DF, fill/finish
Tech transfer and scale-up
GMP manufacturing: DS (mRNA) and DP (mRNA-LNP)
Comprehensive analytical development and QC testing capability
Full CMC and Regulatory support

Drug Substance
Drug Product
Analytical Science & Quality Control
Quality Assurance

Drug Substance Process Development and Manufacturing

Our GMP services include a manufacturing facility with up to 300L scale fermenter for plasmid DNA production and various volume vessels and purification equipment for mRNA transcription and purification.

Drug Product Process Development and Manufacturing

Our DP service include state-of-the-art mRNA-LNP production systems (e.g. Microfluidic and T-Junction mixing techniques) as well as robotic aseptic filling systems.

Drug Product Development

Formulation development, process development and technology transfer
Lyophilization cycle development
Stability, stress study, CCIT, clinical in-use study
25 µL to 10 L scale (feasibility / pilot)
Extensive mRNA-LNP DP characterization techniques: particle size, PDI, encapsulation rate, potency, etc.

Drug Product Manufacturing

Two segregated Vanrx SA25 Robotic filling lines
Microfluidic and T-junction encapsulation processes
Aseptic formulation isolator
Single-use systems
Ready-to-use container-closure systems (vials and pre-filled syringes)

Analytical Science and Quality Control

Our dedicated team of highly trained and experienced analytical and QC professionals, allows us to offer:

Integrated labs that support diverse mRNA modalities
Methods development, transfer and qualification/validation
Product biochemical, biophysical, and biological characterization, and comparability analysis
Comprehensive analytical capabilities for full CMC packages that enable IND/BLA filings
Tox/Clinical lot DS/DP release and stability testing
Reference standard generation, qualification, characterization, storage, and life-time management
Analytical investigation; troubleshooting of GMP manufacturing related issues

Quality Assurance System

Our established global quality system, quality control and operational systems meet or exceed worldwide regulatory standards from the U.S. FDA, EMA, NMPA and other major regulatory agencies. Our commitment to quality is ingrained in our company culture and our employees. We have harmonized our quality assurance (QA) and quality management system across all sites around the world for the clinical or commercial production of biologics and vaccines drug substance and drug product.

WuXi Biologics services cover all critical CMC processes with a timeline of 8 months from DNA to IND filing.

Overview