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  • Vector Platform
  • CMC Platform
  • Manufacturing Platform

High Efficient Promotor Platform GritPAC®

High efficient promotor and enhancer system is able to increase the protein expression largely. Gritgen's GritPAC® platform has been demonstrated in non-human primate animal studies and clinical trials. GritPAC® makes the microgram per liter of protein expression in blood into reality, that broadens our pipeline significantly.


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Next-generation AAV Capsid Platform GritOcul®

Gritgen has developed a next-generation, propriatary AAV capsid platform GritOcul®. Using the innovative capsid, gritgen is developing a long-lasting treatment for ophthamological disease.  


AAV Process Development
1.Upstream process
  • 01
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    HEK293 suspension

  • 02
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    Three plasmids transfection

  • 03
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    Lysis and harvest

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2-4E14 vg/L

Upstream yield

2.Downstream process
  • 01
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    Clarification

  • 02
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    Column chromatography(affinity and anion exchange chromatography)

  • 03
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    Ultrafiltration

  • 04
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    Vertical filtration

  • 05
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    Formulation

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Plasmid Process Development
1.Upstream process
  • 01
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    Cell thawing

  • 02
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    Cell expansion in shake flask

  • 03
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    Scale-up cultivation in fermenter

  • 04
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    Cell harvest

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>85%

supercoiled ratio after fermentation

2.Downstream process
  • 01
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    Continuous lysis

  • 02
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    Column chromatography

  • 03
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    Ultrafiltration

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Quality Control and Release

Integrated quality control system, with full compliance on regulatory requirements and clarified release specifications, ensure the manufacturing capability to meet clinical and commercial demands.

01

Identification
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Identification
  • Target gene

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02

Quantitation
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Quantitation
  • Genome titer

  • Total viral titer

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03

Activity
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Activity
  • Target protein expression

  • Target protein activity

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04

Purity and impurity
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Purity and impurity
  • Residual HEK293 host cell DNA

  • Residual HEK293 host cell protein

  • Residual Benzonase

  • Residual plasmid

  • Molecular mass distribution purity

  • Ration of full capsid

  • Capsid protein purity

  • Replication-competent AAV

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05

Safety
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Safety
  • Sterility

  • Mycoplasma

  • Endotoxin

  • Abnormal toxicity

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Dispensing and Preservation of Final Products
  • Aseptic filling of drug product in isolator
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  • Cryopreservation
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Clinical and Commercial Manufacturing
  • Large scale

  • High capacity

  • Compliance

  • 8,600sq.m.

    GMP facility

  • 100L

    Plasmid production line

  • 2X500L

    AAV production lines

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