Qualification and validation for a new biotechnology production line

Compliance / Security Life Sciences Switzerland

Context and challenges

This client is a Swiss biotechnology company, that has recently been acquired by an international major biopharmaceutical company. This client wished to increase the production of its flagship product at its plant located in Neuchâtel. For this purpose, this company had to set up a new production line (biotech upstream and downstream process). Therefore, this company needed to shut down the whole facility until the new line was fully operational. 

In order to maintain its production capacity, this client needed to reduce the duration of the production shutdown and ensure the proper start-up of the new biotech production line.

This client appointed Assystem Care to get support in the qualification and validation phases for this new production line, applying the ASTM E2500 methodology. Assystem Care has also been appointed to provide a coaching and mentoring program for more than 20 client collaborators (called “Subject Matter Expert”) in order to ensure transfer of skills after implementing  the ASTM E2500 methodology.

Project Scope

Apollo Maturity and Atlas solutions are Assystem Care proprietary solutions and project management set of tools with standardised processes and methodologies.

  • Development of a specific CQV(1) methodology to meet client needs, using Apollo (specific verification module based on risk management and “quality by design” approach) and Atlas solutions for writing and implementing Standard Operating Procedures - SOPs - and the development of project management and follow-up materials:
    • Creation of documents architecture and CQV strategy based on ASTM E2500
    • Set up of a risk based methodology until the handover to production and maintenance once the performance qualifications have been performed
    • Methodology fully integrated in corporate SOP and with local SOPs
  • Implementation of ASTM E2500 qualification methodology approach:
    • In the framework of requirements specification/conception/validation:  development of QRA methodology (Quality Risk Assessment) based on products specific knowledge (quality attributes), to evaluate quality criteria to manage (including process parameters and critical aspects)
    • QRA analysis applied to systems involved (facilities and clean rooms, biotech process equipment, utilities, CSV(2)), including SIP/CIP (Cleaning In Place/Sterilisation In Place) processes. This strategy covered the whole equipment life cycle for qualification and validation (URS, DR/DQ, FAT, SAT, IV/OV, PQ(3))
    • Test capitalisation and follow-up with a matrix set up for each system (materials preparation, upstream/downstream, utilities,  facilities, CSV, IS/AS(4))
  • Training of client “Subject Matter Expert” SME (coaching / mentoring program), about various topics: quality, process, maintenance, qualification, validation and engineering

(1) Commissioning, Qualification, Validation; (2) CSV: Computer System Validation; (3) URS: User Requirements Specifications - DR/DQ: Design Review/Design Qualification - FAT: Factory Acceptance Test - SAT: Site Acceptance Test - IV/OV: Installation Verification and Operational Verification - PQ: Performance Qualification; (4) IS/AS: Information Systems/Automated Systems

Client benefits

  • Significant reduction in shut down duration (20 weeks vs. 36 weeks planned) thanks to drastic optimisation of the schedule, strong involvement of all project stakeholders and changing shifts of workers over several months
  • Reduction in manufacturing costs of products in part due to modifications of some manufacturing process phases (in particular the bioreaction and purification phases)
  • Increased profitability due to better time to market delays and fast relaunch of production
  • Reduction in project non-compliances (quality KPI): >90% (>600 events vs >6650 events), mainly linked to FAT phases and inside the CSV) and due to development and implementation of processes modifications
  • Approval by swiss regulatory inspection for the commissioning of this new production line, without any minor/major/critical remark

In figures


of duration shutdown


weeks vs 36 weeks



life sciences: related projects


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