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GMP Lentivirus Production Service


Creative Biogene has the expertise to assist you with the GMP manufacture of lentivirus.

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GMP Lentivirus Production Service

GMP Lentivirus Production Service

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.

Service Workflow

GMP Lentivirus Production Service

Quality Control

Lentivirus Detection and Tittering Lentiviral Particles
ItemMethodCriterion
Osmotic pressure (mOsm/Kg)USP assay260-350
pHUSP assay7.0-8.0
Sequencing of the GOIRT-PCRPositive
Lentiviral protein-P24 VSVGWestern-blotPattern matches standard
Infection titer (TU/mL)QPCR≥1×10^8
HIV gag p24 antigen (ng/mL)ELISA≥1×10^4
Expression of the GOIWestern-blotPositive
Security Detection
ItemMethodCriterion
Sterility testSterility testNegative
Mycoplasma testFDA mycoplasma assayNegative
Endotoxin testLAL - kinetic turbidimetric≤10 EU/mL
Exogenous virus test in vitroPCRNegative
Exogenous virus test in vivoPCRNegative
Purity Detection
ItemMethodCriterion
Plasmid residual(VSV-G)QPCR≤4×10^8
Large T antigen contaminationELISA kit or western-blotNegative
Large T DNA residualQPCR≤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-blotFI0
BSA contaminationELISA kitFI0

Service Highlights

  1. Separate manufacturing suites
    Three separate state-of-the-art GMP facilities are dedicated to microbial, cell culture and virus manufacturing.
  2. Quality control and quality assurance
    QA and QC group oversee the entire production process from the validation of equipment to the approval of the documents required (SOPs, batch records, validation reports, etc.) to release the GMP product.
  3. Cost saving
    Small footprints combined with high efficiency systems reduce operating costs over longer campaigns and for smaller production runs.
  4. A well-established proven GMP quality system
    Our GMP systems and procedures are developed and maintained to ensure GMP compliance to applicable FDA and EMA regulatory requirements and standards.

Quick Inquiry

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