3P Biopharmaceuticals is a European-based Contract Development and Manufacturing Organization (CDMO) specialized in the process development and GMP manufacturing of biopharmaceutical and cell therapy products.
People, passion and precision come together in a unique method of working.
A highly qualified team accompanies clients through the full life cycle of their products as a robust manufacturing partner: from cell line development to clinical and commercial manufacturing.
3P has a successful track record on a global scale helping customers bringing their candidates from the early stages of development up to clinical phases and, ultimately, to commercialization. In its state-of-the-art biomanufacturing facilities, the company also offers a comprehensive range of analytical and development services as well as continuous regulatory support that will improve the value of its client’s candidates.
3P Biopharmaceuticals offers GMP manufacturing services for biologics obtained both mammalian and microbial expression system.
3P is GMP certified by AEMPS* for:
·· API manufacturing (clinical trials & commercial phase)
·· QC and release of API and Final Product for clinical trials and commercial phase
* Spanish Medicines and Sanitary Products Agency (equivalent to EMA)
· Biologics (NEW BIOLOGICAL ENTITIES /BIOSIMILAR) Development of Bioprocesses and GMP Manufacturing of:
• Recombinant Proteins
·· Advanced therapies (Cell therapy) for non-GMP/GMP processes
• Cell therapy products
• Tissue engineered products
• Cell culture media
• Biomaterials (scaffolds or membranes)
Manufacturing related services:
·· Generation of expression systems and cell lines
·· Process development
·· Bacterial, yeast capabilities (up to 1,000 L)
·· Mammalian capabilities (up to 2 x 200 L)
·· Analytics development/validation
·· Comparability Studies
·· Stability studies (preliminary, GMP, cell banks)
·· Cell bank manufacture, characterization and storage
·· Stability cameras: +25°C, +5°C, -20°C, -80°C
·· QA & Regulatory support
Facilities & equipment
The company operates a 4,707 m² state-of-the-art manufacturing facility which is equipped with a microbial fermentation production suite, with a capacity of 10 L, 100 L and 1,000 L and a mammalian cell culture system fully segregated with a current capacity of 50 L and 2 x 200L.
The facility has all of the necessary utilities required for bulk biologics manufacturing, including purified water, WFI, clean stream, nitrogen and compressed air. A 4,700 SF (436 m2) cGMP warehouse also supports the operation.
In addition to the fit out areas, 3P counts with enough of shell space available for expansion and adaptation to new projects. The facility also contains a cell therapy area and a research and development area for process development and quality control laboratories.
3P has been involved in GMP manufacturing projects starting from gene design up to clinical phase manufacturing and others involving Technology Transfer from several CMO s based in Europe, United States, Argentina and Australia and targeting late stage GMP manufacturing.
3P has experience working with different expression systems: microbial (E. Coli, S. Cerevisiae, H. Polymorpha, P. Pastoris) and mammalian (CHO , BHK, HE K, Hybridomas) for the process development and GMP manufacture of New Biological Entities (NBEs) like fusion proteins, vaccines, monoclonal antibodies among others.
Moreover, the company has extensive experience in biosimilars (development from bacterial and mammalian processes; innovator characterization and comparability studies).
2:30 PM–2:45 PM Jun 4, 2018 (US - Eastern)