Preparative LC

Preparative LC

General Information

Preparative LC

    Preparative Chromatography Experience

    YMC is one of the very few global players in the market that meet the challenging demands in preparative scale chromatography. Our ambition is to provide chromatographic solutions for any compound from its discovery throughout scaling-up into production and its quality control in the lab, as well as positive, active support, chromatographic tools and technical assistance.

     

    In order to optimise preparative processes the employed bulk needs to
    provide:

    • optimised selectivity => maximum output per run
    • mechanical stability => cost efficiency
    • reproducibility => reliability

     

    YMC of today maintains three technology platforms:

    • chemically re-enforced pH-stable YMC-Triart Prep with C18, C8 and customised (e.g. quarternary ammonium) surface chemistries
    • high grade silica phases for preparative HPLC with improved mechanical stability, including polysaccharide phases for chiral applications
    • high resolution IEX prep media in 10, 20, 30 or 75 μm particle sizes with an annual capacity beyond 40,000 litres

    Our substantial investments into facilities and staff represent YMC’s ongoing commitment towards high quality products and technical support:

    YMC’s state-of-the-art silica production facilities allow large lot sizes of more than 500 kg/lot. With the inauguration of our large-scale bonding site in 2004 lots of even more than 200 kg of bonded silica have become routine operations. The annual capacity of YMC’s production plants amounts to multiple tons of spherical silica.

    Moreover, YMC is one of a very few stationary phase manufacturers, who can offer full scalability from sub-2 micron UHPLC phases, through 3 to 5 micron analytical HPLC phases to 10 to 50 micron phases for semi-preparative and preparative scale chromatography. This makes YMC the partner of choice for fast and easy method transfer from (sub)-analytical to process scale separations.

     

     

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    Regulatory Affairs Support

    Since its inception in 1980, YMC has frequently been subjected to a variety of audit formats by major companies with periodical re-audits, specifically from pharmaceutical and/or biotech customers.

     

    As all YMC processes and working procedures are thoroughly monitored and documented, YMC always has been in perfect condition to prove full compliance with the requirements. In addition, YMC consistently provides total responsiveness to suggestions for specific adaptions that customers deem relevant in their individual working environment.

     

    As of today, numerous audits on all core business activities have been completed successfully:

      • Silica production and bonding facilities
      • YMC-BioPro manufacturing (polymer-based media)
      • YMC-Triart (hybrid-style media)
      • Preparative LC-systems and columns
      • Laboratory services (at YMC Europe GmbH)
      • Glass column production (at YMC Europe GmbH)

    and YMC continues to actively encourage customers’ requests for their individual inspection opportunity.

     

    Routinely, the following topics are covered within a specific audit plan (subject to a signed NDA being in place):

    • Corporate information
    • Plant tour (ideally based on applicable working procedures)
    • Quality Manual
    • Drug Master File
    • Regulatory Support File
    • Change Control
    • Business Continuity Policy
    • Supply Guarantee/Supply Agreement
    • Quality Agreement
    • Procurement Documentation.

     

    Corresponding certificates will be provided, e.g. with regard to:

    • BSE/TSE
    • Leachables/extractables
    • Stability data
    • Material Safety Data Sheets
    • Certificates of Analysis
    • Pest control
    • Asbestos
    • Conflict minerals
    • Other solids data relevant to the customer.

     

    YMC will gladly showcase premium quality features to guest visitors – guaranteed.

     

    Contact

    Please contact YMC for pricing or specific solutions for your purification process.

    Michael Ostendorf

    Product Manager Bulk Media

     

    ph. +49 (0)2064 427-280

    Related Categories

    Contact

    • Michael Ostendorf
    • Product Manager
    • Bulk Media
    • ph. +49 (0)2064 427-280