Mammalian Biopharmaceuticals

Clinical to Commerical Supply

Lonza’s facilitiy in Porriño, Spain is located 15 kilometers from Vigo (Pontevedra) and 110 kilometers from Porto, Portugal.  Porriño is a metropolitan town whose main industry is granite production.

This clinical to commercial facility specializes in custom manufacturing of recombinant proteins – ampule thaw to frozen bulk drug substance. Lonza Porriño is a cGMP manufacturing site with a strong quality assurance and regulatory track record.  We offer flexibility of scale and process and always adhere to cGMP, safety, health and environmental practices.  Our fully integrated project management program ensures that each customer’s project is monitored through completion.

Authorized as commercial multi-product manufacturing site by AEMPS (Agencia Española de Medicamentos y Productos Sanitarios-Spanish Medicines and Sanitary Products Agency) and authorized in 2010 for commercial manufacturing by EMA (European Medicines Agency).  The Porriño site obtained USA and Korean FDA approval for commercial manufacturing.

Lonza Porriño Site Specifications

  • Plant Area: 35.460 m2
  • Built Area: 11.350 m2 

 

Lonza Biologics Porriño is an integrated global contract manufacturing organization (CMO) offering a complete range of therapeutic protein manufacturing services. Our capabilities include technology transfer, scale-up and cGMP manufacturing services.

 

Upstream Capabilities:

  • Mammalian Cell Culture Processes (CHO, NS0, Hybridoma, etc.)
  • Seed Train from mL to 50L Single-use Bioreactors
  • Inoculum Train Bioreactors Capacity from 20L to 8000L
  • Production Bioreactors of 10000L
  • Media Preparation up to 10000L Batches
  • Harvest by Centrifugation and Depth Filtration Train

 

Downstream Capabilities:

  • Dedicated ‘non-live’ Processing Areas
  • Chromatographic Columns
  • Viral Inactivation
  • Ultrafiltration / Diafiltration
  • Buffer Preparation up to 12000L Batches
  • Bulk Filling

 

Analytical Development & Testing

  • Raw Material, In-process and Release Testing
  • Development of cGMP Compliant Analytical Methods
  • Complex Biological Activity Assays
  • Physiochemical Analysis
  • Protein Characterization
  • Microbiological Testing