Services

from facilities design to production start-up


Co-management of Projects from
Plant Construction to Start-Up
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Customised project co-management service for the construction of biopharmaceutical plants and the start-up of production.

Our role is to work as if we were part of the client’s staff, fully understand the needs of their process and contribute our experience in the design of the facilities, management of purchasing and installation/qualification of the equipment, management of the drafting and implementation of the standard work procedures (SOPs), drafting annual preventive maintenance plans, calibration, (re-)qualification, establishment of work flows…

In addition, we would provide support to the client in the relationship with the engineering company and the crews involved in the construction of the pharmaceutical plant. In this way, the entire flow of information is streamlined and misunderstandings that could lead to delays in the process are avoided.

The project would end with the start-up of production, providing direct support at the client’s facilities.


Plant Design Based on Process Needs
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We analyze the needs of the client process in terms of scale, equipment, containment, material and generated waste workflows, biodecontamination, etc., to offer the client the solution that allows optimizing the productivity of the facilities.


Support in Process Development and
Scale-Up/Industrialization
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Support in the development and scaling of biotechnological processes (fermentation, cell cultures with mammalian cells, production of viral vectors, enzymatic processes…). Analysis of larger scale equipment, evaluation of the need for technology changes associated with scale-up, scale-up calculations, direct support in the management and execution of scale-up and engineering batches.


Technical and Regulatory Analysis of the Equipment for the Process
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Support in the analysis of the technologies available on the market with the objective of meeting the user requirements specifications (URSs) from the point of view of equipment engineering, the regulations applicable to the process and digital requirements (data integrity, audit trail, user management…).

Technical Training of Personnel
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Training of personnel on scale-up of biotechnological processes, GMP production, maintenance of GMP facilities and supply chain.

Start-Up of the Activity: Management and On-Site Support
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Direct collaboration with the client to launch their production processes. We support all the necessary management and preparation of the facilities, equipment, and personnel for start-up. Additionally, on-site support is offered during the first production batches.

GMP production management
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Support in the coordination and planning of production batches, cleaning and disinfection of facilities, routine preventive maintenance of equipment, optimization of workflows, management of process execution, etc.

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