Mammalian and Cell Therapy manufacturing: pre-clinical to commercial


In the last few years, a significant Pharmaceutical Industry presence has developed in the Tuas Biomedical Park, led by Lonza’s initial trailblazing investment in 2005. As a leader in global custom manufacturing, we have expanded our presence in these growing Asian demographics. The Singapore site part of our worldwide custom manufacturing network provides customers with capacity to successfully develop and commercialize their important products in the global market.

Our Tuas site is a mammalian cell culture manufacturing facility for the contract development and production of biopharmaceutical products, including monoclonal antibodies (mAbs), cellular therapeutics and other recombinant proteins. Our multi-product facility is located in a largely industrial area in western Singapore. We commenced production in cGMP production in early 2011 with bioreactor production systems at 2,000L and 20,000L batch sizes, for both clinical and commercial operation. The site also has process development services for both early phase clinical (such as cell line construction and process development) as well as late phase clinical (such as process characterization and validation).

Lonza Biologics Tuas Site Masterplan

25
thousand m2 cell culture manufacturing facility
4.1
thousand m2 cell therapy manufacturing facility
1.4
thousand m2 Mammalian process development and analytical laboratories

Manufacturing services available span a wide range


Our Singapore facility offers large-scale (20,000 L) and small-scale (2,000 L) GMP mammalian manufacturing services, as well as, cell therapy manufacturing capabilities. It is a multi-product, campaign based, contract manufacturing facility with multiple scales of operation. Furthermore, at the facility we offer a lot of depth in development services for mammalian products.

  • Large-scale mammalian GMP Manufacturing
    • 20,000L production bioreactor suites
      • Multi product inoculum suites
      • Dedicated seed reactor trains
      • Dedicated feed tanks
    • Primary recovery system including centrifugation, depth and terminal filtration
    • Four purification suites
      • Large scale chromatography columns, up to 2.0m
      • Tangential flow and terminal flow filtration systems
      • Product and buffer prep and hold capacity
    • Bulk fill suites - final filling by isolator, mobile stainless steel tanks or pre-irradiated single use bags
    • Bulk product storage temperature ranging from 2-8°C to -80°C
    • Seed train: shake flasks, wave bioreactors (20L and 50L), 200L single use bioreactors
    • Production bioreactors: 2,000L single use bioreactors
    • Primary recovery by depth filtration system
    • Pre and post viral purification suites
    • Small-scale chromatography systems
    • Column sizes 14, 20, 30, 45 and 60cm currently available
    • UF/DF and other filtration systems
    • Column and filter sizes selected based on process and yield requirements
    1. Cell culture development services
      • Cell line development
      • Upstream process development
      • Customer process transfers
      • Cell bank creation and characterization
    2. Purification development services
      • Platform purification process
      • Customer process transfers
      • Downstream process development
      • Purification viral clearance studies
    3. Analytical services
      • Platform analytical
      • Method transfer
      • Stability testing
      • Protein characterization
    • Dedicated allogeneic and autologous cell therapy suites
    • Clinical and commercial manufacturing
    • Dedicated cell therapy media formulation & fill suite
    • Additional space available for expansion

Quality systems and regulatory inspections


We operate local quality management systems that comply with internal policies as well as with national and international standards and regulations (e.g. GMP, PIC/S)

  • United States Food and Drug Administration (US FDA) Code of Federal Regulations (CFR) Title 21, Parts: 11, 210, 211 and 600 (where applicable)
  • Eudralex - Volume 4 Good Manufacturing Practice (GMP) Guidelines
  • International Council for Harmonization (ICH)

We are proud of our excellent track record of over 20 successful inspections from various agencies over the past seven year without any critical observations.