cell culture in normoxia
DESCRIPTION
3P Biopharmaceuticals has the GMP (Good Manufacturing Practices) certification issued by the AEMPS for the manufacture and release of biological active substances, the release of biological drugs and the release of sterile products for both human and veterinary use and for the manufacture and release of cell therapy product: human allogeneic adult stem cells extracted from hearth tissue an "in vitro“ expanded.TRANSCRIPT
At 3P Biopharmaceuticals there is a clear orientation towards achieving results, quality and continuous improvement.
As a CMO, 3P offer specialized and highly customized services to biotechnology and
pharmaceutical companies.
Development and validation of analytical
methods
Development Services Process development, scale-up and validation for advanced therapy products
Cell therapy and tissue engineered products to autologous or allogeneic use. Intermediate products: cell culture media, biomaterials (scaffolds or membranes).
Storage, Distribution and Delivery
Final product formulation for cell based therapies (autologous or allogeneic). Primary packaging: pre-filled syringes, glass vials, cryovials, bags and bottles. Labelling of final container with customized label Cryopreservation and cell banking of final product under GMP conditions (in clean rooms). Controlled storage at different temperatures -20ºC, -85°C or -196°C. Logistical services and shipping validation protocols for advanced therapy products. Completely secure point-to-point chain of control and custody. Ideally, full real-time package tracking.
Facilities
4,500 m² facility with 1,160 m² GMP certified. 840 m² extension area. Fully equipped Analytical and QC laboratories. Biosafety level 2. State-of-the-art electronic facility monitoring system.
Clean steam. Compressed air (free of water, oil and particles). Cooling water (12/16°C, cooling capacity 800 kW). Independent HVAC for clean rooms. Highly purified water, Water for Injection (WFI).
Contact
Address : Polígono Mocholí C/ Mocholí 2 31110 Noáin Navarra – SPAIN
Phone : +34 948 34 64 80
Email : [email protected]
Website : www.3pbio.com