CDMO BIOTECH

EXPERT IN BIOTECH MANUFACTURING

  • Live & Inactivated Bacteria & Viral Vaccines
  • Roller Bottles & Cell Factory
  • Single-use Bioreactors
  • Sterile processing systems
  • Centrifugation, Ultrafiltration, Diafiltration
  • Chromatography
  • Process Development/ Optimitation
  • Storage
  • Cold chain up to -80 ºC
  • cGMP preparation and control of Master and Working Seed Lots of cells, Virus and Bacteria.
  • GMP Upstream & Downstream processes, based on single use equipment.
  • Upstream process optimization for Virus, Bacteria and Cell cultivation.
  • Downstream process optimization, with capabilities for Centrifugation, Purification and Immunopurification.
  • Vaccines formulation.
  • Wide capacity for aseptic filling.
  • Lyophilization: Virus, Bacteria and other biological investigational medicinal products.
  • Stability testing of seed lots, intermediates and finished products.
  • In-use stability studies.
  • Commercial prodution.
  • Labeling & Packaging
  • Wide capacity for physical-chemical and biological control, including sterility test.
  • Implementation of methods of control of intermediate and finished product.
  • Assays in animals models to BSL 3.
  • Preparation of Investigation Medicinal Product Application Quality dossier for Clinical trial IMP authorization.
  • Biological and sterile products release.
  • Storage and Shipment.

Para más información

Contáctenos