BUSINESS

CMO

CMO service

  • Our CMO service facilitates customers’ preclinical programs of AAV gene therapy. Sponsors or academic researchers can be supported by Genixcure’s customized service from design to manufacturing of various serotypes. We offer quasi-GMP grade vectors based on optimized process from plasmids design to QA of produce


    • Process development : we offer customized process development for manufacturing & purification of AAV and plasmid DNA and transfer SOP-driven preclinical CMO
    • Development of Analysis Method : Development of QC analysis method equivalent to GMP grade
    • Customized plasmid & AAV production by cell types and scale

  • 1 AAV Design

    Plasmid / AAV

    Upon request of customers, we design to find an optimized GOI plasmid to certain target cell/tissue and assist customer’s serotype selection in accordance with MoA of each therapeutic program.

  • 2 AAV Manufacturing & Purification

    Plasmid / AAV Production Services

    As an AAV-gene-therapy-focused biotech, Genixcure leverages its expertise and experience to professionally work as a preclinical CMO service provider

    • Equipped with its own clean room facilities
    • Production scale
      • Adherent cell (cell stack → maximum 80 layers)
      • Suspension cell (single use → maximum 25L)

  • 3 Quality Assurance

    Analysis and Quality Assurance Services

    We issue CoA(Certificate of Analysis) normally including analytical assurance of followings

    • AAV (DP)
      • Titation (qPCR/ddPCR)
      • Full/empty ratio (TEM/qPCR and ELISA ratio analysis)
      • transduction efficiency (fluorescent microscope/TCID50)
    • Drug substance
      • Endotoxin
      • SDS-PAGE
      • stability test
      • HPLC analysis
      • Mycoplasma test

Main Composition

  • Manufacturing
  • Purification
  • Analysis

  • Process development

  • Customized Plasmid manufacturing

  • Customized AAV manufacturing

equipment

Bioreactor

Fluorescenece microscope

Cell stack

Features

  • Design of optimized GOI plasmid to targets and serotypes
  • Both adherent and suspension platform available
  • Production scale
    • Adherent cell – 150mm cell culture dish ~ cell stack (80 layers)
    • Suspension cell – 1~25L scale (wave bioreactor)

  • Development of Harvest
    and lysis

  • Purification process optimization

  • High concentration and clarification/formulation

equipment

FPLC

Ultracentrifuge

Features

  • Harvest and analysis methods for the target
  • Buffer exchange and concentration using UF/DF
  • Refining process using FPLC (~25 L)

  • Characteristics analysis

  • Viral safety analysis

  • COA Issuance

equipment

ddPCR

Endotoxin

HPLC

Osmolality

pH, conductivity

Fluorescenece Microscope

RT-PCR

iBright imaging system

Microplate reader

Features

  • Titer Analysis
    • qPCR, ddPCR
  • Purity analysis
    • SDS-PAGE, HPLC, Full/empty ratio analysis (transmission electron microscope analysis)
  • Safety Analysis
    • Aseptic test, Endotoxin, Mycoplasma
  • Certificate of Analysis (CoA)

How it works

  • Apply for service

  • Discussion on
    Customized
    production

  • Confidentiality
    agreement

  • Process development,
    sample production and
    analysis of quality of
    samples produced

  • Product delivery
    with issued CoA

  • Starting from the discussion of virus scale via email, call, or F2F meeting
  • Finding agreed range of characteristics analysis by customers’ use of viruses
  • Finalizing customers’ request on CoA features and quantitative grade of each feature
  • QA-based CoA issued and material transfer

Contact Us