Biopharmaceutical and Cell Therapy Products

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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.
3P Biopharmaceuticals is equipped to handle both
New Biological Entities (NBEs) manufacturing
(fusion proteins, vaccines, monoclonal
antibodies) as well as Biosimilars Project
specific customization of many manufacturing
related services such as analytical method
development, process validation, stability
studies, formulation, advanced therapy services
(cell therapy) and Master and Working cell bank
generation, characterization and Storage can be
offered.
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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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Biosynthesis Development
3P BiopharmaceuticalsRD Department supports
development and optimization of processes
offering batch, high cell density fed-batch
fermentation, and perfusion, including medium and
feeding strategy.
By evaluating critical parameters of the process,
such as related impurities control from the early
beginning, the Process Validation team ensures
successful scale-up and tech transfer.
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Purification Development
3P Biopharmaceuticals supports the development of
different biologics (innovative, bio-superiors
and biosimilars) defining a robust, scalable,
time and cost effective process in compliance
with regulatory requirements.
RD Department supports the development of
purification, covering different steps of
process, such as effective and well-controlled
refolding, tangential flow filtration,
chromatography media selection and optimization,
virus inactivation, and filtration.
By evaluating critical parameters of the process,
such as related impurities control from the early
beginning, the Process Validation team ensures
successful scale-up and tech transfer.
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Contact
Address
Polígono Mocholí C/ Mocholí 2 31110 Noáin
Navarra. SPAIN GPS 42.753298, -1.635239
Email
info_at_3pbio.com
Visit
http//www.3pbio.com