3P Biopharmaceuticals, S.L. (3P)
Workpackage (WP) participation
3P Biopharmaceuticals is a Contract Manufacturing Organisation (CMO) specialised in the development and manufacture of biologics (proteins and other biological molecules) as well as advanced therapy products for clinical trials and commercial stages. The collaborators are well versed in cell and molecular biology, in isolation, culture, characterisation of somatic cells and adult stem cells. It has 4’500 m2 facilities with clean rooms, equipment, processes and quality system in accordance with Good Manufacturing Practices (GMP). 3P is currently composed of a multidisciplinary and qualified team of 56 employees, including pharmacists, biologists, chemists, engineers and laboratory technicians.
3P cumulates competences in Research & Development, Quality Control and Maintenance Departments, Project Management, Quality Assurance and Financial Department.
Main tasks attributed to the project
3P is well experienced in viral and non-viral transfection methods (electroporation, lipofection, etc.). Thus, they will evaluates the definition of optimised transfection parameters (WP3, 4), particularly developing two types of buffers for transfection and storage of pigment epithelial cells. The development is focused on satisfactory rates of cell transfection and provides good results in terms of morphology, growth and viability of transfected human IPE and RPE cells. A stability study concerning storage and transport conditions for these reagents will be transformed.
3P prepared SOPs and a manufacturing guide according to the standards set by GMP, describing the raw materials used, product specifications, and all the quality and in-process controls required. 3P will produce the necessary reagent lots for the clinical trial (WP7) in clean rooms. Finally, 3P also collaborates editing the Investigational Medicinal Product Dossier (IMPD), and assisting in the dissemination of the objectives and results of this project in an industrial environment and for the general public as well (WP10).
Dr. Pablo Arandaparanda@3pbio.com
Dr. Pablo Aranda, PhD in Biochemistry and Cellular and Molecular Biology. During his career he has worked in the field of human adult stem cells and has participated in several projects of regenerative medicine. He is the current head of the Cell Therapy Area at 3P Biopharmaceuticals and has significant expertise in cell therapy processes.