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Advanced Therapies Production Platform (PPTA)

Presentation

The Advanced Therapy Production Platform (PPTA) of the Biobizkaia Health Research Institute supports basic and clinical research for the production of cell therapies. PPTA offers a research support service to researchers from Biobizkaia and Cruces University Hospital (HUC), as well as to professionals from other hospitals, research centers or companies, who would need assistance in preclinical and clinical studies in the field of Cell Therapies.

The PPTA provides support for the design and development, validation and production of cell therapies and their associated quality controls, as well as for the transfer of manufacturing techniques from processes already developed in other facilities, thereby expanding the scope of application of cell therapies. This service is always carried out in compliance with the good manufacturing standards specific to Advanced Therapy medicines (NCF/GMP). (Part IV. Specific NCF guidelines for advanced therapy medicines). PPTA provides support for the design and development of the product, validation of the process, production of cell therapies, associated quality controls and technology transfer of manufacturing processes developed at other facilities, thus expanding the application of cell therapies. This service is always performed in compliance with GMP guidelines specific to Advanced Therapies (Part IV. Guidelines on GMP specific to Advanced Therapy Medicinal Products).

To carry out all these tasks, PPTA is composed of Production, Quality Control and Quality Assurance departments.

PPTA is part of the Certera Project (Consorcio Estatal en Red para el desarrollo de Medicamentos de Terapias Avanzadas), and has funding allocated in the 2022 grant call. PPTA thus participates in the network of scientific-technical infrastructures coordinated by the Carlos III Health Institute (ISCIII) and is part of the consortium that brings together, coordinates and amplifies the capacities of the Science, Technology and Innovation System (SECTI) in the field of Advanced Therapies.

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Infrastructures and equipment

PPTA facility in Biobizkaia is located on floor 0 of the HUC extension building (Bio4 building). This facility has an extension of over 200 sq m and more than half is dedicated to the production and storage of material in class D, C and B areas. It has several class B independent rooms allowing for simultaneous execution of independent processes without the risk of cross-contamination. In addition, the facility includes quality control laboratories for microbiological testing as well as for other safety and characterisation controls.

The B classification of PPTA's production rooms allows for class A work in open systems by means of laminar flow cabinets located in independent rooms. In addition, there is a multi-purpose room, which will allow the incorporation of new equipment for future needs.

Sterile production also relies on a CliniMACS Prodigy, a closed system designed to automate and standardize complete manufacturing processes of cellular products for cell therapy and ex vivo gene therapy. The CliniMACS Prodigy is equipped with an electroporator that enables nucleic acid transfer protocols without viral vectors.

In addition, the facility is equipped with refrigerated centrifuges, high-capacity CO2 incubators, inverted microscopes for image acquisition, enabling cell and gene product manufacturing with full guarantee, besides production in the CliniMACS Prodigy.

Finally, quality control laboratories contain all the necessary resources to perform safety and efficacy tests on cell therapy products following the analytical methods defined in the European Pharmacopoeia European Pharmacopoeia.

STERILITY TEST: (Eu Ph 2.6.27.)

  • Advanced therapy isolator ATI-1130 (LITEK PHARMA)
  • BACT/ALERT® 3D (BIOMERIUX)

MYCOPLASMA TEST: (Eur Ph. 2.6.7)

  • Biosystems QuantStudio™ 5 Real-Time (THERMO FISHER)

ENDOTOXIN TEST: (EU Ph. 2.6.14)

  • Endosafe Nexgen -PTS (CHARLES RIVER)
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Platform members

Contact form

Contact form - Advanced Therapies Production Platform(PPTA)

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Plaza Cruces S/N | 48903 Barakaldo
Pho.: 94 618 26 22

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