Anthony is a C&Q consultant for the Geneva office. He explains us one of his missions he realized in APC Project and Biomass Probes.
Context
APC project:
Upgrade of one of the production suites to allow the introduction of high-performance process, new generation, and so, to ensure continuity of supply and long-term supply of drug substances.
Biomass probes:
Continuous process improvement with the installation of new biomass probes in bioreactors.
Project Goal
APC project:
Installation of new equipment and modifications of existing equipment, to allow the future production of this new generation process.
Challenge – The integration of these new equipment and the qualification of this new process, must not affect the current processes.
Biomass probes:
Installation of new biomass probes (currently not used to release the process), to ensure a reliable and continuous measurement of cell concentration in the bioreactors.
Make sure that these new probes do not have any impact on the bioreactors at the different stages of the process (especially CIP).
Scope of the project (extended to 1 site, several sites, which departments are involved etc.)
APC Project:
This upgrade affects only one production line, but in several areas (Media Preparation Area, DSP Area, USP Area).
In addition, this project was carried out in coordination with several pharmaceutical companies (technological partnership).
The main additions are:
– 2 new “TFF” (tangential Filtration Flow) skids on 2 (existing) bioreactors to increase cell density (USP area)
– 1 new media preparation tank and 4 intermediate media storage tanks, in connection with the addition of the TFFs on the 2 bioreactors (MP Area)
– 1 new CIP skid to clean the new media tanks
– 1 new SPTFF skid to increase the concentration of the protein of interest. (DSP Area)
The different departments impacted by this project are (mainly): Manufacturing, Engineering, Utilities and Quality
Biomass probes:
These new probes were installed on 6 bioreactors of different volumes, on one of the customer’s production lines.
Activities requested by the client
APC project:
The client solicited many consultants to fulfill several roles on the project. Form the project manager, to the executing qualification protocols, through engineering and quality expertise.
Biomass probes:
Activities requested were Qualification activities.
What CVO-EUROPE does for this project
APC Project:
Several CVO-EUROPE consultants have been deployed on this project in different domains (quality, automation, validation …).
In the Validation department, for which I worked, the consulting teams were split according to the area production (MP, DSP, USP, CIP stations…). CVO-EUROPE staff for validation dealt more specifically MP, USP and CIP stations areas).
Our commissioning and qualification activities consisted of:
– Writing and execution of Commissioning/IQ/OQ equipment qualification protocols
– Writing of the qualification protocols of the CIP and SIP
– Challenge the validation strategy (especially on CIP and SIP cycles)
– Writing of the final reports of the protocols
Note: The activities of PQ and engineering runs are managed internally by the Manufacturing department.
Following the realization of the 1st engineering run, several optimization possibilities were highlighted. So, CVO-EUROPE also provided support during the assessments made in the various risk analyzes to define the validation strategy to apply
Subsequently, the client wanted to use our expertise developed in the APC project framework to update their validation documents (protocols and reports templates)
Biomass probes:
Only one consultant was needed on this project. My activities were:
– Writing and support for the execution of the OQ protocols (the spray pattern)
– Writing and execution of IQ protocols.
– Support the internal project manager to coordinate interactions with probes provider and manufacturing people.
Status for CVO-EUROPE in terms of activities
APC project:
The activities attributed to CVO-EUROPE have been successfully executed. The project is now entering the second phase of the engineering runs.
Biomass probes:
The probes have been installed successfully. And the different OQ tests were run.
When will the project be completed
Qualification phases requiring consulting are now complete for the two projects.
New experience for me
The main novelty for me, lies in the TFF skid. It’s a technology I had never approached, and whose the applicability to a USP process I did not know.
This project also allowed me to expand my knowledge of the DSP process
CVO-EUROPE’s know how in APC Project