Biologics Manufacturing Services - PowerPoint PPT Presentation

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Biologics Manufacturing Services

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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.The Company offers an integral service for the process development and manufacture of biopharmaceutical products. – PowerPoint PPT presentation

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Updated: 19 August 2015
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Title: Biologics Manufacturing Services


1
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.
2
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 Cell bank storageAs 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.
3
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.
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
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.
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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