Biopharmaceutical and cell therapy products
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3P Biopharmaceuticals is a European CDMO specialized in developing and manufacturing biopharmaceutical and cell therapy products from early stages through commercialization. They support process development from batch fermentation to perfusion, as well as analytical development and validation of testing methods in compliance with regulations. 3P Biopharmaceuticals also generates and characterizes cell banks in ISO5-classified clean rooms, and stores raw materials, intermediates, and finished products at controlled temperatures.
Biopharmaceutical and cell therapy 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. Development and Validation of Analytical Methods
- 2. Process Development Biosynthesis Development 3P Biopharmaceuticals R&D Department supports development and optimization of processes offering batch, high cell density fed-batch fermentation, and perfusion, including medium and feeding strategy. 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.
- 3. 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
- 4. 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 属 C, -20 属 C and -80 尊 C can be accommodated in control temperature in real-time.
- 5. Contact Address : Email : www.3pbio.comWebsite : Phone : Pol鱈gono Mochol鱈 C/ Mochol鱈231110 No叩in Navarra. SPAIN +34 948 34 64 80 Fax : +34 948 34 67 02 info@3pbio.com