Creative Biogene has the expertise to assist you with the GMP manufacture of lentivirus.
Our promise to you:
Guaranteed product quality, expert customer support.
Creative Biogene has the expertise to assist you with the GMP manufacture of lentivirus. Our top priorities are to streamline our platform processes or work with you to design a process that meets your specific needs and expedites your transition to the clinic. Whether your intended clinical use is direct injection or ex-vivo transduction, our team has years of experience in the production, purification, and characterization of lentivirus.
The GMP production of clinical grade lentivirus for gene therapies requires technology of the comprehensive methods to product, purify and characterize lentivirus in a well-established proven GMP quality system. As a leader of lentivirus production, Creative Biogene combines the leading lentivirus production technology with systematic GMP procedural controls that have been developed to ensure clinical product quality, safety and consistency for gene therapy clinical trials. Creative Biogene has developed a proprietary and highly efficient system for ultra-high titer lentivirus production including that with clinical scale.
|Lentivirus Detection and Tittering Lentiviral Particles|
|Osmotic pressure (mOsm/Kg)||USP assay||260-350|
|Sequencing of the GOI||RT-PCR||Positive|
|Lentiviral protein-P24 VSVG||Western-blot||Pattern matches standard|
|Infection titer (TU/mL)||QPCR||≥1×10^8|
|HIV gag p24 antigen (ng/mL)||ELISA||≥1×10^4|
|Expression of the GOI||Western-blot||Positive|
|Sterility test||Sterility test||Negative|
|Mycoplasma test||FDA mycoplasma assay||Negative|
|Endotoxin test||LAL - kinetic turbidimetric||≤10 EU/mL|
|Exogenous virus test in vitro||PCR||Negative|
|Exogenous virus test in vivo||PCR||Negative|
|Large T antigen contamination||ELISA kit or western-blot||Negative|
|Large T DNA residual||QPCR||≤2×10^5|
|Benzonase contamination (ng/mL)||ELISA kit||≤0.2|
|E1A DNA residual (copies/mL)||QPCR||≤2×10^5|
|Total DNA residual (μg/mL)||Southern-blot||FI0|
|BSA contamination||ELISA kit||FI0|