Good manufacturing practices (GMP) are required for pharmaceutical product employed in clinical trials and advisable for preclinical studies.
3P Biopharmaceuticals offers GMP manufacturing services for biologics obtained through mammalian, yeast or microbial systems.
3P is GMP certified by AEMPS* for:
* The Spanish Agency of Medicines and Medical Devices (equivalent to EMA)
See here our GMP certification
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 our customers in terms of quality, quantity and time to market in the development and production of material for preclinical, clinical and commercial phases.
With GMP certification granted by the competent authority (AEMPS), and the experience of its professionals working in regulated environments, 3P is positioned as an alternative necessary for success in the development of Biotechnology products.
In order to provide a global offering to our clients, 3P has one of the first facilities in which the Sartorius cell culture system, the Cultibag STR, was introduced.
This single-use technology allows us the necessary flexibility to adapt to the needs of our customers while reducing production costs and accelerating time-to-market by eliminating unnecessary cleaning validations.
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.
3P Biopharmaceuticals has the facilities and the ability to perform the early stages of formulating a finished product. Robust agreements with leading companies have been established to provide comprehensive and quality service always maintaining control of all processes and leading the trials.
Fill & finish and lyophilization
In addition to our capacities for the manufacture of medical products, 3P Biopharmaceuticals is able to provide, through our partners, access to various finishing options, allowing customers to benefit from their experience in aseptic filling and secondary packaging.
Knowing how important is the Project to our customers and, in an effort to cover and supply all the activities of the value chain of the development and production of our clients molecules, 3P has robust agreements with the most specialized companies in Lyophilization to guarantee the success of this stage without loosing the control over the Lyo process. All of our technological partners are GMP certified and matches with our Quality requirements to be aligned with our exigencies to maximize the percentage of succes of each phase of the project.