mammalian cell culture
DESCRIPTION
In order to provide a global offering to 3P clients, 3P has one of the first facilities in which the Sartorius cell culture system, the Cultibag STR, was introduced.TRANSCRIPT
Cellbanks
Generation and characterization of
master/working cell banks
3P Biopharmaceuticals efforts have been focused on the installation of two separate rooms for the preparation of ISO5-classified cell banks with state-of-the-art biosafety cabinets based on the important development of the first phases of biologics.
Cell bank
storage As a fundamental part of the chain of value of the products manufactured by 3P Biopharmaceuticals, storage of raw, intermediate and finished materials at 5 ° C, -20 ° C and -80 º C can be accommodated in control temperature in real-time.
GMP Manufacturing
Good manufacturing practices (GMP) are required for pharmaceutical product employed in clinical trials and advisable for preclinical studies.
3P Biopharmaceuticals offers GMP manufacturing services for biologics obtained through mammalian, yeast or microbial systems.
3P is GMP certified by AEMPS* for:
API for clinical trials and commercial.
QC and release of medicinal products for clinical trials and commercial.
The Spanish Agency of Medicines and Medical Devices (equivalent to EMA) See here 3P GMP certification
Mammalian Cell Culture In order to provide a global offering to 3P clients, 3P has one of the first facilities in which the Sartorius cell culture system, the Cultibag STR, was introduced.
This single-use technology allows us the necessary flexibility to adapt to the needs of 3P customers while reducing production costs and accelerating time-to-market by eliminating unnecessary cleaning validations.
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. • Highly purified water, Water for Injection (WFI). • Clean steam. • Compressed air (free of water, oil and particles). • Cooling water (12/16°C, cooling capacity 800 kW). • Independent HVAC for clean rooms.
Contact
Address :
Phone :
Email :
Polígono Mocholí C/ Mocholí 2 31110 Noáin Navarra – SPAIN
+34 948 34 64 80
[email protected] [email protected]
Website : www.3pbio.com