Manufacturing of Biopharmaceutical Products - PowerPoint PPT Presentation

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Manufacturing of Biopharmaceutical Products

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3P Biopharmaceuticals is the first Spanish CMO that offers full service to develop and manufacture processes and products of Advanced Therapy.Cell Therapy Department have broad knowledge and know-how in stem cells from human bone marrow, adipose tissue, cornea, and somatic cells such as osteoblasts, chondrocytes, ephitelial and endothelial cells, and other cell populations (hybridomas and tumor cells). – PowerPoint PPT presentation

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Title: Manufacturing of Biopharmaceutical Products


1
Welcome to 3P
3P Biopharmaceuticals is a European-based
Contract Development and Manufacturing
Organization (CDMO) specialized in the process
development and GMP manufacture of
biopharmaceutical and cell therapy products from
early stages (POC,PC) up to clinical and
commercial.
2
Awards and Distinctions
  • The company was awarded the prize of most
    innovative company
  • of Navarra by the magazine Actualidad
    Económica in 2008.
  • Recognized by Gobierno de Navarra with Moderna
    label
  • Founding agreement with ENISA, the National
    Innovation
  • Company
  • Member of the Spanish Association of
    Bio-Companies (ASEBIO).
  • Recognized by ANCES as a Technology based
    Innovative
  • Company (EIBT).

3
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 (12/16C, cooling capacity 800
  • kW).
  • Independent HVAC for clean rooms.

4
Biologics
  • 3P Biopharmaceuticals offers a highly integrated
    range of services to support the development and
    manufacture of biological products.
  • Custom manufacturing of biologics from mammalian,
    yeast, and bacterial systems are developed from
    proof of concept to commercial stages being able
    to adapt to regulatory requirements for every
    phase (GMP certified).

5
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.
6
Contact
Address
Polígono Mocholí C/ Mocholí 2 31110 Noáin Navarra
SPAIN
Phone
34 948 34 64 80
Fax
34 948 34 67 02
Email
info_at_3pbio.com
Website
www.3pbio.com
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