3P Biopharmaceuticals, a contract development and manufacturing organization (CDMO) specialized in the process development and GMP production of biologics, has completed the project for the expansion and improvement of its facilities in Noáin, Spain that had been carried out over the past few months. The investment exceeded the €5 million in addition to the €8 million that 3P has invested since 2013.
 
The new facility design is part of the company’s strategic plan designed to position 3P as a an international CDMO. 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 processes already in commercial stages. In addition, 3P has incorporated technology and equipment to obtain greater competitiveness in this highly demanding market. 
 
The new facilities have been GMP-certified by the AEMPS (The Spanish Agency of Medicines and Medical Devices).
 
As part of this recent project, 3P 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. 

The process development area has been equipped with aninnovative air handling design that is similar design to the one used in its 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. The ambr 250 allows 3P to develop 24 different experiments concurrently. This capacity facilitates rapid decision-making for future manufacturing processes. In addition, this technology strengthens the capacity of 3P to carry out process characterization activities, an essential phase to drive the drug to the market.  

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 development. The mammalian cell culture area has been enhanced thanks to the acquisition of a new 50 L single use bioreactor. This provides an option for small-scale batch manufacture as well as for intermediate cell expansion. 

3P is also making investment efforts to improve data management in the analytical areas including 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 including mass spectrometry, chromatography equipment, bioanalytical analyzers 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, said, “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.”