Drug Substance
Our GMP services include a manufacturing facility with up to 300 L scale fermenter for plasmid DNA production and various volume vessels and purification equipment for mRNA transcription and purification.
For Sequence to Cell Bank
mRNA DS suite #1
Sequence synthesis
Sequence synthesis in 2-4 weeks; codon optimization
Vector construction
A matrix of vector backbones with different UTRs, polyA, restriction sites, etc.
Strain & clone screening
E. coli strain and clone screening for stable and high production of plasmid DNA
Bacterial cell banking
PD & GMP cell banking; cell bank release and testing
WuXi Biologics provides a matrix of vector backbones with different designs of promoters, UTRs, polyA, restriction sites, etc.
mRNA DS suite #2
mRNA Production Process
pDNA linearization
• Selection of restriction enzyme • Optimization of reagent concentration and reaction condition to ensure complete linearization
GMP plasmid DNA intermediate production • State-of-the-art GMP suites • Multiple single-use fermenters up to 300 L • Platform process with high yield
Purification of linearized pDNA
in vitro transcription
• With or without cap analogs • Optimization of reagent concentration and reaction conditions to achieve high yield of mRNA & complete digestion of pDNA template
GMP drug substance
mRNA recovery*
• One suite of pDNA linearization • One suite of mRNA synthesis • One purification suite for mRNA, with extensive utilization of advanced single use technology
Enzymatic capping*
• Optimization of reagent concentration and reaction conditions to achieve high capping efficiency and minimize enzyme cost
mRNA purification
*Not required for co-transciptional capping
Drug Product
Drug Product Manufacturing
Our DP offerings include state-of-the-art mRNA-LNP production systems as well as robotic aseptic filling systems.
• 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)
Drug Product Development
• Microfluidic and T-Junction mixing technologies • 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.
From sequence to LNP for all mRNA programs
Flexible dosage forms: liquid and frozen vials, freeze-dried vials and pre-filled syringes
Microfluidic Mixing Technology
Impingement Jets Mixing Technology
0.6 m 2 freeze-dryer equipped with AI software and nucleation control technology
Powered by FlippingBook