KOREAN

YUHANPROMOTES

BETTER HEALTH AND LIFE

Yuhan Chemical is doing its best to supply excellent APIs for the healthy lives of people around the world.

YUHAN CHEMICAL

    Yuhan Chemical has built API manufacturing capability as the core competitiveness since its foundation in 1980.
    We have a remarkable comparative edge in process development based on the accumulated experience.

    Characteristics of Process Development

    Drug discovery

    API development

    Clinical trials

    Launch and
    commercialization

    Process development

    Preclinical

    • · Synthetic route scouting
    • · A board range of scale-up possible,
      from lab to commercial scale
    • · Non-GMP supply

    Clinical

    • · Process familiarization studies
    • · Process safety assessment & simulation for scale-up
    • · Process development & optimization studies
      (optimal parameter ranges & critical parameter
      justification)
    • · Troubleshooting and process modification

    Commercial

    • · Technical transfer to manufacturing plant
    • · Continuous process improvement for cost reduction
    Analytical development

    Preclinical

    • · Analytical method development for IPC &
      release tests
    • · Major impurity identification

    Clinical

    • · Identification & characterization of RS
    • · Trace analysis (GTI) & impurity profiling
    • · Forced degradation studies
    • · MV/MT

    Technologies

    Crystal Engineering & PAT

    • · Enhancement of filterability (Particle size & shape)
    • · Purity & quality control
    • · In-situ monitoring of particle characterization using FBRM & PVM
    • · Understanding of the crystallization process

    Over 200 Chemical Reactions

    • Catalytic Reaction ·
      Metal catalyzed Hydrogenation (Palladium, Platinum, Vanadium etc.)   
      Ring-closing metathesis (Grubb’s catalyst)   
      Enzymatic resolution (Lipozyme, Alcalase, Novozyme)   
    • Cross Coupling Reaction ·
      Suzuki coupling reaction ( Pd₂(dba)₂, PdCl₂[P-(t-Bu)₂ph]₂)   
      Sonogashira coupling ( Pd(ph₂P)₄, Pd(OAc)₂)   
      Grignard reaction   
    • Others ·
      Ozonolysis   
      Cryogenic reaction (-80℃, n-BuLi, n-Hexyl Lithium)   
      Thin film evaporation   
      Ion exchange resin purification   
      Oxygen contamination control   

    Process Safety & Simulation

    • · Basic process hazard review
    • · Thermal hazard identification (DSC & TGA)
    • · Process risk assessment (RC1e and iC Safety)
    • · Physical properties assessment for mixture
    • · Mixing efficiency & Heat transfer
    • · OEL (Occupational exposure limits) control

    Flow Chemistry (Under Development)

    • Understanding of flow chemistry ·
    • Application of flow reaction using in house tubing system ·
    • Introduction of flow system in 2017 ·
    • Introduction of flow system for kg scale (2017~) ·