Analytical Science and Quality Control
• 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 for GMP manufacturing related issues
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
Identity
Purity
Impurity
Potency
Safety
pDNA supercoiled% A260/280 by UV absorbance
pDNA sequencing Restriction enzyme digestion
pDNA
Residual dsRNA Residual host cell protein by ELISA Residual host cell DNA Residual solvent Residual antibiotics Residual DNA template
S terility Bioburden Mycoplasma Endotoxin
RNA integrity and fragment Capping efficiency polyA tail length Encapsulation efficiency LNP size and zeta potential LNP morphology
In vitro GOI expression by Cell-based Assay(CBA)
RNA length RNA sequencing
RNA
RNA-LNP
Lipid identification
• Document management/ training • Deviation/CC/CAPA • Quality agreement management • Management review
• Batch release • Warehouse management • Product reception, storage, and distribution • Handling of abnormal and nonconforming materials and products • Supplier management
Quality Assurance System
• Internal audit • Batch release
• Sample management • Retained sample management • Reference standard management • Stability management • Environmental monitoring • Contamination and cross- contamination control strategy • DS/DP production technique transfer • Risk assessment of NPI • Clearance and changeover • Cleaning and disinfection
• Calibration and maintenance • Pest control • Validation management • Water system/HVAC
• Distribution and control of label
About WuXi Biologics
WuXi Biologics is a leading contract research, development and manufacturing organization (CRDMO) that provides end-to-end capabilities to healthcare organizations worldwide. With operations in China, the United States, Ireland, Germany, and Singapore, we enable our partners to effectively and efficiently bring biologics and vaccines to patients worldwide through our comprehensive and high-quality drug development model.
wuxibiologics.com | info@wuxibiologics.com The world’s leading global single-source platform from concept to commercialization.
5-12-2023
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