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.
1. 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.
2. 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
3. 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.
4. 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.