GMP Virus Packaging

Creative Biolabs is developing state-of-the-art technologies and facilities to produce AAV, lentivirus and adenovirus with a rigorous GMP quality system to meet the needs and expectations of clinical material customers. We have established a strong process development and GMP team of virologists and technologists, experienced quality control (QC) professional and GMP research team to ensure end-to-end quality compliance. We offer flexible and high-quality GMP virus packaging services, ranging from construction design to lentiviral vector production, concentration, and titration.

Bioreactor for GMP-Compliant Cell CultureFig1 Bioreactor for GMP-Compliant Cell Culture

Cell Line Production and GMP-Compliant Cell Culture

Creative Biolabs has developed a proprietary suspension of HEK293 and HEK293T cell lines grown in animal-free conditions. Cell lines rapidly optimized for scalable production of all serotypes and adeno-associated virus chimeras (AAV) can also be developed to produce adenoviruses and lentiviruses.

Creative Biolabs uses high-density adherent cell culture bioreactors to expand adhesion to HEK293 and HeLa culture processes. High titer viral vectors can be produced through either transfection or infection method in batch mode. The bioreactor system enhances the upstream process and production.

AAV, Lentiviral and Adenovirus Packaging

AAV, Lentiviral and Adenovirus Packaging

Upstream production platform

  • Triple transfection of adherent cells (HEK293, 293T cells)
  • Triple transfection of suspension cells (HEK293, 293T cells)
  • Adhesion virus-based adherent cell production (HEK293, 293T cells)
  • Suspension cell production based on helper virus (HEK293, 293T cells)

Downstream purification platform

We offer gradient ultracentrifugation and large-scale chromatography purification services (IEX, AEX, Affinity, SEC, etc.) based on the specific needs of our customers. With our experienced production, quality control team, and expertise, we are confident to provide our customers with the best yield and purity.

Virus Packaging QC Assays

We offer comprehensive assay development and in-process testing services to ensure product characterization, quality and purity. Our analytical capabilities include:

  • Purity and impurities
  • Viral vector purity (SDS-PAGE, silver staining)
  • Residual polyethyleneimine (SDS-PAGE)
  • Residual iodixanol (HPLC)
  • Residual host cell protein (ELISA)
  • Residual host cell DNA (qPCR)
  • Residual plasmid DNA (qPCR)
  • Vector genomic titer (qPCR)
  • Total viral particle titer (ELISA)
  • Microbiological safety and quality
  • Bioburden (direct vaccination)
  • Endotoxin (LAL / color method)

For more details, please feel free to contact us for project quotations and more detailed information.

For Research Use Only | Not For Clinical Use

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