Bacterial Vector

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Hands-on experience in process development and GMP manufacturing of bacterial-based therapies

Live and live-attenuated bacterial vectors have been extensively studied for their applications in gene therapy, oncolytic bacterial therapy, vaccines, and more. Various bacterial strains, including Bifidobacteria, Salmonella, Escherichia coli, and Listeria monocytogenes, may be naturally sourced, engineered, or genetically modified to enhance their therapeutic potential. In 2016, the FDA defined these bacterial vectors for drug delivery systems as microbial vectors used for gene therapy (MVGT) to express human tumor antigens, cytokines, growth factors, enzymes, therapeutic proteins, or nucleotides. To help global clients translate their research into clinical applications more efficiently, Porton Advanced leverages its extensive experience to provide integrated CDMO services ranging from microbial banking to aseptic filling and finishing of injectables.

The scientists at Porton Advanced possess extensive knowledge and hands-on experience in handling naturally screened, engineered, and genetically modified bacterial strains, including Salmonella, Escherichia coli, Listeria monocytogenes, and more. Our state-of-the-art facility is fully equipped with bioreactors for aerobic and anaerobic fermentation, ultrafiltration liquid exchange systems, and sterility assurance systems.

Services

We offer integrated CMC services for bacterial vectors:

  • 01
    Strain construction and screening (gram-positive/ gram-negative)
  • 02
    Microbial banking and characterization
  • 03
    Process development
  • 04
    GMP production for pre-clinical, clinical, and commercial supplies
  • 05
    Analytical method development and optimization, analytical qualification, and validation
  • 06
    Fill & finish
  • 09
    CMC information writing and regulatory submission

Therapeutic applications

  • 01

    Oncolytic bacteria

  • 02

    Bacterial cancer therapy/ bacteria-mediated cancer therapy/ Bacterial-mediated Tumor Therapy

  • 03

    Vaccine

  • 04

    Gene therapy

Capability for various strain types

Porton Advanced's capability spans from aerobic to strictly anaerobic bacterial strains.

Strain Type Source Examples
Wild-type strain domestication Strains from customer or compliant suppliers Lactobacillus acidophilus
Lactobacillus plantarum
Enterococcus faecium
Wild-type strain domestication Staphylococcus aureus
Salmonella
Strains engineered with plasmids Attenuated Listeria monocytogenes (including GOI plasmid)
Genetically modified strains Attenuated Salmonella 
(Metabolic gene mutation and functional gene expression)

Comprehensive analytical and testing strategies


Here is an example testing list for final injectables of oncolytic bacteria therapy:

  • 01

    Physical and chemical properties

    •  Appearance
    •  Visible particulates
    •  Insoluble particles
    • Container content
  • 03

    Identity

    • Colony Morphology
    • Gram Stain
  • 03

    Content

    • Bacterial Cell Count
  • 04

    Gene Stability

  • 05

    Potency

  • 05

    Safety

Please consult with our experts for a complete list of tests available.

Project timeline for IND CMC study

Porton Advanced can deliver a bacterial vector-related IND CMC project, from clone screening to GMP production and QC release, within 6 to 7 months.

Clients & Partners

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