biopharmaceutical and cell therapy products
DESCRIPTION
A GMP European biotechnology company certified CMO, specialized in the development and manufacturing of biologics for biotechnology and pharmaceutical companies.3P Biopharmaceuticals is a Europe-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 stages.TRANSCRIPT
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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 C can be accommodated in control temperature in real-time.
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Biosynthesis Development 3P BiopharmaceuticalsR&D 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.
R&D 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
Email : [email protected]
Visit : http://www.3pbio.com
Polgono Mochol C/ Mochol 2 31110 Noin Navarra. SPAIN GPS 42.753298, -1.635239
Address :