Regarding the diagnosis site
The Diagnostics site is integrated into the new Pherecydes facilities built in Nantes. The plan and set up of the diagnosis site have been carefully designed, followed and monitored by our own staff according to the advises of consultants. In order to support them, CERIS, an architectural firm specializing in pharmaceutical sites have been appointed by Pherecydes Pharma. In addition, Nantes Metropole which hosts the laboratory is supported by AIA architects which is specialized in hospital and clean room installation. All these actors finalized the construction plans in April 2018. Regular site construction monitoring meetings take place with Nantes metropole, AIA, CERIS and Pherecydes Pharma (Q4-2018) and minor modifications/adaptations are implemented as the construction progresses.
From 2021, a dedicated team was recruited to lead the set-up of the diagnostic laboratory, with the support of expert consultants (5QBD-Biotech). The set up requires huge work, on the phagogram test it-self and on the QMS (Quality Management System). The 2 main achievements are :
- The development and validation of the IVD test (Phagogram) in accordance with the IVD Directive 98/79/CE
- (ii) the design and implementation of a QMS compliant to the ISO 15189 (Medical Biology Laboratory).
Indeed, to comply to the Directive 98/79/CE, a dossier, called “Technical documentation”, must be available, containing the following topics (a) The analytical evaluation of the IVD - In Vitro Diagnostic -; (b) The set up of a QMS - Quality Management System - ; (c) The Risk Analysis.
Afterwards, the “self-certification” according to the Dir 98/79/CE can be carried out (with the dead line : May 2022).
The phagogram 1.5 was developed by the Diagnostic manager (PhD, PharmD), arrived in May 2021, with the expert technician (transferred from Pherecydes R&D Department) in liaise with the CSO and Quality Director. The analytical performance of the phagogram was performed Q4-2021, showing its reproducibility and robustness.
The design of the QMS was defined Q4-2021, by the expert consultant 5QBD-Biotech, in liaise with the new QA engineer (arrived in Sept 2021) and diagnostic team.
Regarding the production site
An agreement has been signed with MB Pharma so as to upgrade its production site in a GMP standard.
Pherecydes reviewed and supervised the organisation for setting up the quality control laboratories, including the choice of equipment’s and machineries in line with GMP compliance. All along the years of the project, Pherecydes Pharma wrote documentation required for regulatory such as detailed definition of the project, user requirement specifications for equipments, validation master plan, master standard operational procedures which explain the way Pherecydes Pharma wants to manage the site and the quality on site (deviation, change control, Preventive actions and corrective actions, training management, audit...)
Most equipment were now bought and transferred to our production site (MB Pharma).
The equipment qualification, training and qualification of the MB Pharma team, choice of GMP raw material, including buffer solution, aseptic process validation, and documentation writing were performed in 2019/2020, to ensure that MB Pharma could produce batches compliant to GMP/ICH requirement.
A strong collaboration was developed over the years between Pherecydes Pharma and MB Pharma teams, thanks to discussions, meetings, audits, improvement plans. The production plan and process robustness were enhanced with the arrival of a new Industrial Operation Director in March 2021 in Pherecydes Pharma.
All GMP batches produced in 2020 and 2021 (total of 10 batches) were all confirmed by the QP (Qualified Person) of MB Pharma, demonstrating the capability of the CDMO to produce batches compliant to GMP/ICH requirements, in a consistent manner.
