3P Biopharmaceuticals is a European-basedContract Development and Manufacturing Organization (CDMO) specialized in theprocess development and GMP manufacture of biopharmaceutical and cell therapyproducts from early stages (POC,PC) up to clinical and commercial.
In collaboration with our technology partners, we offer a COMPREHENSIVE SERVICE, assisting our clients in terms of every need arising including the development and manufacture of active ingredients (API), pharmaceutical development and essential regulatory aspects.
SERVICES WE OFFER
1º Microbial Fermentation
Development of Biologics (Bacterial and Yeast Systems) from discovery phases until commercial: Up to 10L, 100L, and 1,000L for microbial fermentation in GMP; Akta purification systems (Explorer, Pilot, and Ready) and transfer by means of closed circuits (SART).
2º Mammalian cell culture
Development of Biologics from discovery phases until commercial: Up to 400L in GMP;disposable system; Akta purification systems (Explorer, Pilot, and Ready) and transfer by means of closed circuits (SART).
3º Cell therapy
Development of cell culture media and biomaterial for clinical use; development and production of stem cells for allogeneic cell therapy; manufacture of a tissue engineered product for autologous treatment of skin lesions and GMP validation.
4º Related services
Generation of protein expression systems; development and validation of analytical methods; generation and characterization of MCB and WCB; cell bank storage; development of stability studies; release of raw materials, drug substances and drug products; GMP and Regulatory consulting assessment.