Mammalian Manufacturing Capabilities

Employees standing between large vats

Reach Our Mammalian Experts:

mammalian@lonza.com

  • Introduction

    Superior Facilities, Worldwide Locations

    Lonza is hard at work developing the world’s most advanced biotechnology manufacturing processes and extensive network of biopharmaceutical manufacturing facilities.  We know that global access is important to you and your pipeline.  Here at Lonza, we are dedicated to building clean and efficient facilities with a range of production scales to accommodate every customer’s outsourcing needs.  Our manufacturing staff is committed to using the most advanced production technology to optimize your process and ultimately reduce your cost of goods.

     

    Lonza’s Mammalian Cell Culture Production Services Include:

    • Monoclonal antibodies and recombinant proteins
    • Start-up biotech to large pharmaceutical companies
    • Cell line construction and PD to regulatory support
    • Laboratory scale to commercial supply
    • Over 30 years in industrial mammalian cell culture
    • Stirred tanks, airlift & single-use bioreactors
    • Advanced technologies
      • GS System™, Epibase™, Potelligent® CHOK1SV

       

      Lonza’s Mammalian Locations:

      Pre-Clinical to Clinical

      Clinical to Commercial

    • Pre-Clinical to Clinical

      Our pre-clinical to clinical manufacturing services offer scales of 200L to 2000L.  We have two production sites that offer comprehensive pre-clinical mammalian manufacturing across the globe.   These two state-of-the-art cGMP plants -- one in Thames Valley technology corridor in Slough, UK and the other in the Tuas, Biomedical Park in Singapore, 24 miles from Changi Airport -- offer a global and secure solution for your outsourcing needs.

      For more details on each facility, please visit our site pages by clicking on the site names below:

      Slough, UK

      Lonza operates a 65,000 square foot multi-product cGMP manufacturing facility in Slough, UK, close to London's Heathrow airport. The facility is used to manufacture therapeutic grade monoclonal antibodies and recombinant proteins, using small to mid-scale fed-batch suspension culture of mammalian cell cultures.

      The UK facility was the first multi-product licensed contract manufacturing facility to be licensed by the FDA, with its original Establishment License for the production of monoclonal antibodies first granted in 1985. Since then, regular inspections by the FDA and Europe’s MHRA have been hosted for both monoclonal antibodies and recombinant proteins.

      The cGMP facility houses cell banking, production (fermentation and purification) and quality control laboratories. Contained within the two fermenter halls are numerous air lift and stirred-tank bioreactors with a wide range of manufacturing capacities (up to 2,000 Liters) able to handle pre-clinical and early clinical supply. Disposable, single-use bioreactors (SUBs) are also available. Each reactor has associated inoculum suites, media preparation areas and primary recovery equipment (comprising continuous centrifuge for cell removal, depth filtration, concentration and 0.2μm filtration equipment).

      Capacity:

      • 1 x 200L (Airlift)
      • 1 x 800L (Stirred)
      • 3 x 1,000L (Single-use)
      • 1 x 2,000L (Airlift)
      • Associated Purification Suites
      • Process R&D Services

       

      Tuas, Singapore

      Lonza, with more than 25 years of custom manufacturing experience, has built Asia’s most advanced mammalian cell culture manufacturing facility for the contract development and production of biopharmaceutical products, including monoclonal antibodies (mAbs) and other recombinant proteins.   In addition, the facility will produce cell based therapeutic products.

      Lonza has built Asia’s most advanced mammalian cell culture manufacturing facility for the contract development and production of biopharmaceutical products, including monoclonal antibodies (mAbs), recombinant proteins and cellular therapies.  

      This new facility commenced cGMP production in early 2011 with a complete range of mammalian bioreactor production systems (200L to 20,000L lot sizes) for both clinical and commercial operation. 

      In early 2012, the completion of a second building on the Singapore site introduced new laboratories for a full range of process development and analytical services to expand our process development services capabilities, plus cGMP manufacturing suites for cell based therapeutic products.

      Capacities:

      • 200L
      • 1000L
      • 5000L
      • 4 x 20,000L (Stirred)
      • Associated Purification Suites
      • Process R&D Services
    • Clinical to Commercial

      Our clinical to commercial manufacturing services offer scales of 1500L to 20000L.  We have two production sites that offer comprehensive clinical and commercial mammalian manufacturing.  These two state-of-the-art GMP plants -- one located outside Boston, MA in Portsmouth, NH (USA) and the other close to Vigo in the northwest of Spain, in Porrino --  offer a global solution to our outsourcing needs.

      For more details on each facility, please visit our site pages by clicking on the site links below:

      Portsmouth, New Hampshire, USA  

      The Portsmouth facility has been designed specifically for the production of therapeutic proteins derived from mammalian cell culture using deep tank fermentation systems. This facility houses stirred tank as well as airlift reactors for maximum flexibility.

      This multi-product facility was designed for the manufacture of bulk purified therapeutic proteins for use in clinical studies and in-market supply. Lonza has incorporated over 20 years of manufacturing experience into the design of the Portsmouth facility. Close contact with the regulatory authorities and consultants has led to a design that provides customers with the confidence that their products are being manufactured to cGMP standards.

      Since 2001 the Portsmouth facility has hosted 21 regulatory inspections by FDA, EMEA, Health Canada, Japan, Brazil, and Mexico. Lonza's Portsmouth facility is currently approved for 6 customer products. The facility design minimizes downtime, which maximizes throughput and provides customers with economically viable, long-term production.

      Capacities

      • 3 x 5,000L (Airlift)
      • 4 x 20,000L (Stirred)
      • Associated Purification Suites

       

      Porrino, Spain

      The Porrino facility was commissioned in 1960 by a local company and since that time it is producing a number of bio-pharmaceutical products for clinical and commercial purposes. The 95,000 sq. ft. facility is approved by the FDA and the AEMyPS (Spanish Medicines Agency).

      Lonza's Porriño facility offers customized services to best meet the individual needs of each product. The technical staff evaluates products and their unique requirements to tailor our process technologies to meet those requirements. Lonza's unique experience in mammalian cell culture enables us to offer customers a broad spectrum of possibilities to fulfill their manufacturing needs.

      Capacities:

      • 4 x 10,000L (Stirred)
      • Associated Purification Suite