Microbial Manufacturing Capabilities

Large Chromatograph Column in Kourim, Czech Republic

Reach Our Microbial Experts:

microbialbiopharma@lonza.com

  • Introduction
  • Systematic Technology Transfer
  • GMP Production
  • Quality Inspections

  • 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 are located in Visp, Switzerland, and Hopkinton, Mass. (USA), 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)

    Hopkinton, Massachusetts, USA 

    • 40L, 150L, 800L, 2,000L, 2,800L

    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.

     

    Tables 1 and 2:  Lonza’s FDA inspection history at our Hopkinton, MA, USA and Visp, Switzerland facilities.

                Hopkinton                            Agency                              Comments             
    October 2009 FDA GMP; rhATryn
    August 2008 FDA; EMEA / Netherland GMP
    April 2008 FDA PAI
    March 2006 FDA / Team Biologics GMP
    December 2005 EMEA / Netherlands PAI and GMP
    August 2005 EMEA / Netherlands PAI and GMP
    November 2003 FDA / Team Biologics GMP
    August 2002 EMEA / UK PAI
    November 2001 FDA / Team Biologics GMP
    September 2000 FDA / Team Biologics GMP
    April 1998 FDA / CBER PAI

     

     

                  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