BUSINESS

CDMO

ANLBIO CDMO

  • ANLBIO supports the process from early research and development of gene therapy using AAV to the non-clinical stage. Provide a vector equivalent to the GMP grade through AAV serotype selection, optimized GOI plasmid design, production and QC that is appropriate for the customer's request.

    • Process Development : Optimization of Plasmid DNA / AAV Production and Refining Process and Technology Transfer
    • Development of Analysis Method : Development of QC analysis method equivalent to GMP grade
    • Plasmid production : Plasmid production of various scales
    • AAV production : AAV production of various cell types and scales

  • 1 Non-GMP AAV Design

    Plasmid / AAV

    ANLBIO provides various analysis services (optional) based on excellent experts for AAV sample production experience and quality control for samples produced.

    • Design of optimized GOI plasmid in target cell/tissue through ANLBIO's know-how and selection of AAV serotype

  • 2 Non-GMP AAV production and refining service

    Plasmid / AAV Production Services

    ANLBIO, a company specializing in the development of AAV-based gene therapy products, provides custom viral packing services for the desired purpose.

    • High-quality AAV production and purification through its own clean room facilities
    • High-quality AAV production and purification through ANLBIO's clean room facility
    • Production scale
      • Adherent cell (cell stack → maximum 80 layers)
      • Suspension cell (single use → maximum 25L)

  • 3 Bioanalytical 및 Biologics Quality Control/Assurance Service

    Analysis and Quality Assurance Services

    Based on analysis service, ANLBIO guarantees the quality of samples produced by issuing a CoA (Certificate of Analysis).

    • AAV Sample Analysis and Quality Assurance Service
      • Titation (qPCR/ddPCR)
      • Full/empty ratio (TEM/qPCR and ELISA ratio analysis)
      • transduction efficiency (fluorescent microscope/TCID50)
    • Raw material drug analysis and quality assurance service
      • Endotoxin
      • SDS-PAGE
      • stability test
      • HPLC analysis
      • Mycoplasma test

Main Composition

  • Production
  • Refinement
  • Analysis

  • Process development

  • Cultivation of Customized Scale cells

  • Production of Customized Viruses

dquipment

Bioreactor

Fluorescenece microscope

Cell stack

Features

  • Optimization according to Target cell/tissue GOI plasmid and serotype design
  • Production through two cell types at the request of the customer
  • AAV production at various scales
    • Adherent cell – 150mm cell culture dish ~ cell stack (80 layers)
    • Suspension cell – 1~25L scale (wave bioreactor)

  • Separation of cell culture fluid

  • Concentration of culture fluid

  • Production of high-concentration samples

equipment

FPLC

Ultracentrifuge

Features

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

  • Virus titration

  • Analysis of purified sample impurities

  • Analysis of sample pH, conductivity,
    and osmotic pressure characteristics

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 of the production sample

PROCEDURES of OUR SERVICES

  • Apply for service

  • Discussion on
    Customized
    production

  • Confidentiality
    agreement

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

  • Transfer of CoA and
    samples produced
    througj consignment

  • After applying for service, determine the capacity of samples to be produced through e-mail/wired consultation/meeting
  • Select the scope of characteristic analysis according to the purpose of the samples produced
  • After producing customized samples that meet the standards through process development, sample production, and characteristic analysis, transfer CoA and samples produced through consignment

Contact Us

  • Contact Us Online

    cmc@anlbio.com

  • Contact Us by Phone

    031 - 215 - 1511