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  • Contract Development Services

    : Cell Line Development, Process & Analytical Development, Formulation Development, non- GMP & cGMP Manufacturing (1KL) and IND Filing support

  • Large-scale Drug Substance Manufacturing Service

    : Clinical & Commercial DS Manufacturing at 5KL~15KL scale

    Small-scale Drug Substance Manufacturing Service

    : Clinical & Commercial DS Manufacturing at ≤ 2KL scale

    Aseptic Filling Service of Drug Product (liquid, lyo, vials, syringes, cartridges)

    : Clinical & Commercial Drug Products

  • Mycoplasma Detection Test

    : Direct or indirect culture method using culture medium or indicator cell

    In vitro Virus Test

    : 14/28 day method with detector cell lines MRC-5/Vero/CHO-K1/A9/NIH3T3 etc.

    MVM qPCR Test

    : Detection of MVM in sample by Real Time PCR

    Microbiology Test

    : Microbial Challenge Test,
    Antimicrobial Effectiveness Test,
    Endotoxin/Sterility/Bioburden Test

    Contract QC Test

    : Contract quality control testing for batch release of commercial DP

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