Biologics Manufacturing Services

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3P Biopharmaceuticals
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.
Development and Validation of Analytical Methods
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Process Development
Biosynthesis Development
Analytical Development
Effective development and qualification of
analytical and bioanalytical methods for end
product testing (API and final drug product) is
developed in compliance with regulatory
requirements.
3P Biopharmaceuticals RD Department supports
development and optimization of processes
offering batch, high cell density fed-batch
fermentation, and perfusion, including medium and
feeding strategy.
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Quality Control Services

• Product comparability studies.
• Analytical test methodsm
• validation
• Product characterization
• Traceability of identity
• Potency assays
• Stability studies

• Flow cytometric analyses
• Impurity controls
• Genetic stability
• Polymerase chain reaction
• Microbial assays
• Infectious disease testing

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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.
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Contact
Address Polígono Mocholí C/ Mocholí 2
31110 Noáin Navarra. SPAIN
Email info_at_3pbio.com rrhh_at_3pbio.com
www.3pbio.com
Website
Phone / Fax Phone [phone] Fax 34 948
34 67 02