3P Biopharmaceuticals has successfully completed the project for the expansion and improvement of its facilities in Noáin (Spain) that had been carried out over the past months. The investment exceeded the 5 million euros invested in this project in addition to the 8 million euros that 3P has invested since 2013.
The new facility design is part of the company’s strategic plan and means a huge qualitative leap that positions 3P as a CDMO of international reference. This project has equipped 3P with new capacities and capabilities to meet the growing demands of the market and the needs of its current clients, with some of their projects already in commercial stages. In addition, 3P has incorporated innovative technology and equipment to obtain greater competitiveness in this highly demanding market.
The new facilities have already been GMP-certified by the AEMPS (The Spanish Agency of Medicines and Medical Devices).
The future of bioprocesses
3P Biopharmaceuticals is a CDMO specialized in the process development and GMP production of biologics. The company collaborates with its clients to provide personalized solutions at every stage of process development and GMP manufacturing from pre-clinical to commercial supply.
Thanks to this recent project, 3P has maximized success in the process development area through a two-tier strategy. On the one hand, it has built segregated new areas equipped with specific equipment for the culture of microbial and mammalian cells. These facilities allow 3P to develop different processes simultaneously.
On the other hand, the process development area has been equipped with an innovative air handling design that is similar design to the one used in our GMP manufacturing plant. This minimizes the risk of cross-contamination during the execution of different simultaneous experiments.
Also noteworthy is the acquisition of a Single-Use Multi-Parallel Bioreactor: ambr® 250 that together with other analytic equipment, have required an investment of almost 1 million euros. The ambr® 250 allows 3P to develop 24 different experiments concurrently. This capacity facilitates rapid decision-making for future manufacturing processes. Furthermore, this technology strengthens the capacity of 3P to carry out process characterization activities, an essential phase to drive the drug to the market.
Expansion of GMP manufacturing capacity
The expansion of the GMP manufacturing area has focused on the amplification of the bacterial area. Thus, allowing 3P to transfer in and manufacture such products at different stages of their clinical development.
The mammalian cell culture area has been enhanced thanks to the acquisition of a new 50 L single use bioreactor. This provides an attractive option for small scale batch manufacture as well as for intermediate cell expansion.
Robustness of the other areas
3P is making extraordinary investment efforts to improve data management in the analytical areas: Development and QC by incorporating LIMS technology (Laboratory Information Management Systems). LIMS is a comprehensive solution that improves quality and safety throughout the entire product lifecycle: from sample intake to the delivery of accurate results, driving smarter decisions throughout the entire process. It also optimizes data management, accessibility, traceability, integrity and long-term value.
The analytical area has been also equipped with state-of-the-art technologies like mass spectrometry, chromatography equipment, bioanalytical analysers and a Maurice system (Protein Simple). All these technologies allow the rapid determination of identity, purity and characterization of proteins with a higher precision.
This Project specific to facility growth and adaptation, has been accompanied with an important increase in human resource. During 2018, more than 50 professionals have joined the company and is expected to exceed the 245 personnel forecasts for 2019.
Damaso Molero, General Manager at 3P says, “this investment is consolidating the important successes we have achieved with our clients, with two of their products already in commercial stages. We have no doubts that our capacity and knowledge in mammalian cell culture will allow us to compete in this important market”.