Objectives

The main Objective of this WP6 is to design the scale-up of the selected solution as low cost treatment against Chagas disease. The final output of the WP will be the design of a production line for the production of pilot batches of medicaments for ulterior trials. The scientific-technical objectives to achieve are the following:

·         Objective 1: To obtain a complete knowledge on the medicament characteristics and properties at lab scale, including formulation, materials of reference time control and operation conditions.

·         Objective 2: Based on laboratory results, the second objective is to obtain all the design parameters related to the production process, including design of auxiliary systems, equipments, and materials, and the definition of working conditions.

·         Objective 3: To design production areas, including building materials, unit operations, materials fluxes, sterilization needs, operative procedures and environmental issues.

·         Objective 4: To get the necessary Pilot Lots to be used in the Clinical Trials in WP 7

Description of work (possibly broken down into tasks), and role of participants The Work Package 6 will start after the selection of the optimum solution within the previous work packages. WP 6 will involve the industrial partners (Praxis, ELEA) and the research partners CIBER-BBN and UB, which will help in the translation of the solutions from research at laboratory scale to pilot scale. The WP6, lead by ELEA, is split in the following tasks:

·         Task 1. Assessment of medicament properties at laboratory scale.

·         Task 2. Design of the production process.

·         Task 3. Design of production areas.

 

·         Task 4. Production of Pilot lots for Clinical Trial under GMPs.