Genevoyager provides small-scale manufacturing and process development services for early-stage studies of Bac/Sf9 system AAV drugs. non-GMP services are consistent with the large-scale manufacturing process for early-stage studies and animal studies, preclinical studies including pharmacodynamic and toxicology studies, etc.
• 20-200L scale Bac/Sf9 system AAV production
• Ultracentrifugation (optional) and AKTA Ready/Pilot purification system
• Quality Inspection
• Batch records, production summary reports, CoA documents
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Category |
Quality Attributes |
Analytical Method |
|
Identification |
Capsid protein identification and purity |
SDS-PAGE |
|
Characteristic sequence identification |
First generation sequencing (target gene) |
|
|
Purity |
Capsid purity |
SDS-PAGE |
|
Aggregation |
SEC-HPLC |
|
|
Empty shell rate |
TEM, AUC |
|
|
Content and potency |
Physical titer |
ELISA |
|
Genomic titers |
qPCR,ddPCR |
|
|
Infection titer |
TCID50 |
|
|
specific activity |
Infectious titers, genomic titers |
|
|
Potency - Gene Expression |
Cell-based in vitro mRNA expression or protein expression（qPCR，ELISA，Western Blot） |
|
|
Potency-activity |
Cell-based in vitro biological activity, animal experiments |
|
|
Impurity |
Host cell DNA residues |
qPCR |
|
Nuclease residues |
ELISA |
|
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Host cell protein residues |
ELISA |
|
|
Specific process-related residues (e.g., affinity ligands, PEI, decontaminants) |
ELISA, HPLC |
|
|
Security |
Bacterial endotoxins |
Gel limit test method |
|
Replicating viruses（rcAAV,BEV） |
Cultivation method |
|
|
Aseptic |
Membrane filtration method |
|
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Mycoplasma |
Cultivation method，qPCR |
|
|
Viral exogenous factors |
Cultivation method |
|
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Physical examination |
Appearance |
Visual method |
|
Packing quantity |
/ |
|
|
Visible Foreign Objects |
Light Inspection Method |
|
|
pH |
pH value measurement method |
|
|
Osmotic pressure |
Freezing point detection method |
|
|
Insoluble particles |
Photoresist method |
US: 3675 Market Street, Suite 200, Philadelphia, PA19104 Tel: +1 (215) 205-6963 | +086 027-65023363
E-mail: hui.wang@genevoyager.com
China: No128, Guanggu 7th Rd, East Lake High-tech Development Zone, Wuhan, China Tel: 17720522078
E-mail: marketing@genevoyager.com
US: 3675 Market Street, Suite 200, Philadelphia, PA19104 Tel: +1 (215) 205-6963 | +086 027-65023363
E-mail: hui.wang@genevoyager.com
China: No128, Guanggu 7th Rd, East Lake High-tech Development Zone, Wuhan, China Tel: 17720522078
E-mail: marketing@genevoyager.com
