Microbial Manufacturing Capabilities

Large Chromatograph Column in Kourim, Czech Republic

Reach Our Microbial Experts:

microbialbiopharma@lonza.com

  • Introduction

    Versatility and Experience

    Lonza's microbial manufacturing professionals are highly experienced in developing, optimizing and scaling-up microbial fermentation and product isolation processes. Technical experts are involved right from the start of the project and remain involved during process transfer and production. This ensures a smooth transition from the project’s early phase up to commercial scale.

    Over the years, Lonza has become a recognized leader for outsourced microbially derived active pharmaceutical ingredients (APIs) and chemical intermediates.  Our versatile manufacturing facilities for injectable-grade biopharmaceuticals produced in microbial organisms is located in Visp, Switzerland, with additional oral-grade facilities in Kourim, Czech Republic.

  • Systematic Technology Transfer

    Through systematic and closely regulated operational and documentation processes, managed by dedicated program managers, we design and implement seamless technology transfer from your facility to our development and manufacturing sites. To date, we have transferred numerous clinical and commercial production processes. These transfers have covered scale-up factors from 5 to over 100 and scales ranging from 40L to 15,000L.

  • GMP Production

    Our state of the art facilities extend across both North America and Europe.  We offer oral, topical and injectable grade production throughout the world.   All our facilities conform to cGMP standards and have been successfully audited by customers and regulatory authorities.

    Visp, Switzerland 

    • 20L, 1,000L, 2x15,000L

              (expansion planning under way for additional mid- and large-scale capacity)

    Kouřim, Czech Republic 
    • 5x15m3, 5x50m3, 2x75m3 (oral-grade only)
  • Quality Inspections

    We know that quality and cGMP compliance is an absolutely essential part of this business. Vigorous adherence to cGMPs is something that Lonza takes very seriously.  We dilligently work closely with global regulatory authorities to adhere to current guidelines and best practices.

     

    Table 1:  Lonza’s inspection history at our Visp, Switzerland facility.

                  Visp                           Agency                Comments
    March 2010 FDA PAI
    December 2009 Swissmedic GMP Inspection
    November 2008 Swissmedic GMP Inspection  (BPMSS, GMP Laboratory)

    October 2008

    FDA & Swissmedic

    PAI
    September 2007 Swissmedic GMP Inspection of 15,000L facility (for manufacturing license)
    October 2006 Swissmedic GMP Inspection
    February 2006 FDA Combined PAI / Systems Inspection
    September 2004 Swissmedic Routine GMP Insp. + license extension