3P Biopharmaceuticals offers a highly integrated range of services to support the development and manufacture of biological products.Custom manufacturing of biologics from mammalian, yeast, and bacterial systems are developed from proof of concept to commercial stages being able to adapt to regulatory requirements for every phase (GMP certified).
Industrial production of chemical acids glutamic acid
Biologics Manufacturing Services
1. 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.
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.
2. 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.
Cellbanks
3. Microbial Fermentation
Fermentation is an important part of industrial microbiology and 3P has one of the most advanced
microbial growth installations on the market equipped with state-of-the-art equipment
manufactured by the best suppliers in the Biotechnology industry, in every area of specialty.
With a capacity of up to 1000L fermentation in stainless steel seed trains associated with a flexible
growth in volume, 3P has become the first biotech company in Spain with sufficient flexibility to
meet the needs of customers in terms of quality, quantity and time to microbial fermentationmarket
in the development and production of material for preclinical, clinical and commercial phases.
4. Mammalian Cell Culture
In order to provide a global offering to clients, 3P has one of the first facilities in which the Sartorius
cell culture system, the Cultibag STR, was introduced.
With a current capacity of 400L and growth forecasts of up to 4000L, 3P will become one of the
first CMO’s in Spain in the global offering of capacities to cover all stages of development and the
scaling of processes based on cell culture in mammal cells.
5. Cell Therapy
3P Biopharmaceuticals is the first Spanish CMO that offers full service to develop and manufacture
processes and products of Advanced Therapy
Cell Therapy Department have broad knowledge and know-how in stem cells from human bone
marrow, adipose tissue, cornea, and somatic cells such as osteoblasts, chondrocytes, ephitelial
and endothelial cells, and other cell populations (hybridomas and tumor cells).
6. GMP Manufacturing
Cell and Tissue Processing
Standard operating procedures to obtain properly biological
material, according to current regulations and GMPs.
Tissue processing (including bone marrow, peripheral
blood)
Mechanical and enzymatic digestion, immunoselection, cell
depletion.
Cell and Tissue Culture
Isolation, culture and harvest of human cells (primary
cultures and cell lines; suspension or adherent cells;
differentiated cells and stem cells).
Cell culture in Normoxia or Hypoxia conditions.
Custom manufacturing of cell therapy medicinal and tissue
engineered products.
Batch production record and cGMP documentation
development.