The Agenda
The Consortium has outlined a set of activities that believes will enable the development of valuable knowledge. These activities will embrace different areas of work, namely:
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clinical validation and production of bacteriophage cocktails and small domain antibodies, in Phase I, II/III studies;
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construction and implementation of a production unit for the development and manufacturing of innovative biopharmaceuticals;
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development of a qualification and internationalization strategy oriented towards the promotion of new bioproducts that will be manufactured in the new production unit;
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plan for dissemination and promotion of the advances and results of the different subprojects/activities.
Work Package 1
Development and clinical validation of a national platform for the production of innovative biological medicines - Clinical trials, Process Development and GMP production
(Leader: TechnoPhage | Co-promoters: LxBio, VectorB2B and FFUL)
This work package covers a batch release process for research purposes, phase I/II, II/III clinical trials according to the specificities of each phase of clinical development.
The developments of this work package will take place between January 2023 and December 2025 and includes clinical research and validation actions - clinical validation work will be carried out by TechnoPhage, clinical trial monitoring by VectorB2B and biologic drug pharmacovigilance by VectorB2B under FFUL consulting.
First Product to be commercialized
Work Package 2
Implementation of the biopharmaceutical development production unit for commercial phases and as services for third parties. Definition of an internationalization plan and qualification of the Biopharmaceuticals production unit
(Leader: LxBio | Co-promoters: TechnoPhage, VectorB2B and FFUL)
WP2 will take place between January 2023 and December 2025 and it will include the design, planning and construction of a new biopharmaceutical production unit, in order to empower LxBio to operate in all commercial phases of the product life cycle, enabling a productive capacity that will allow to introduce new biopharmaceuticals into the market.
Together with co-promoters VectorB2B, FFUL and TechnoPhage, LxBio will be responsible for the implementation of a business project for the productive up-scaling of the biopharmaceutical unit.
Work Package 3
Plan for dissemination and promotion of results, as well as technical and financial management of the project
(Leader: LxBio | Co-promoters: TechnoPhage, VectorB2B and FFUL)
The work carried out under this WP will take place between January 2023 and December 2025 and will be a responsibility to all elements of the Consortium. Structuring this dissemination plan will ensure an effective dissemination of Bio-Hub activities and goals throughout the project lifetime, in order to give visibility to the technical-scientific skills developed, as well as the generation of new biological therapies that are on the verge to enter the market.
The Agenda will be led by an internal management and coordination team, which will ensure both technical and financial execution of the different activities and tasks, as well as, supporting the representative members of the Consortium during the lifetime of the project.
