Manufacture of Biopharmaceutical Products - PowerPoint PPT Presentation

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Manufacture of Biopharmaceutical Products

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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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Title: Manufacture of Biopharmaceutical Products


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. The Company offers an integral
service for the process development and
manufacture of biopharmaceutical products
2
Cell Banks
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.The integrity of all materials from the
beginning of the process to final storage are
guaranteed. All refrigeration units and freezers
are fully qualified and calibrated to ensure the
robustness of storage.
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
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
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