Cryopreservation and Cell Banking

1
Development and validation of analytical methods
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.
2
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).

3
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, -85C or -196C.
• 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.

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.

• Clean steam.
• Compressed air (free of water, oil and
  particles).
• Cooling water (12/16C, cooling capacity 800
  kW).
• Independent HVAC for clean rooms.
• Highly purified water, Water for Injection
  (WFI).

5
Contact
Address
Polígono Mocholí C/ Mocholí 2 31110 Noáin Navarra
SPAIN
Phone
34 948 34 64 80
Email
info_at_3pbio.com
Website
www.3pbio.com