Context:

In December 2011, our biopharma customer had just completed the construction of a purposed-built mammalian cell lines bio-plant.

BQG was contracted to manage and coordinate the start-up of the plant and test the various installations & systems (upstream / downstream process development) under Verification guidelines - ASTME E2500.

BQG was also in charge of managing the appointed teams to be brought up to speed with the best practices and quality standards by the end of 2013.

Time and materials project capped on budget and planning

 

 Objectives:

  • Conduct a risk-based analysis of the systems as well as compliance status, with respect to the work done up to the end of phase 1 (EPCMV).
  • Build a two-year project plan dedicated to switch and prepare systems for routine production and first GMP campaign.

 

Approach:

As part of BQG's preliminary assessment, a need for a taskforce of experts was identified, to successfully address engineering and routine operations constraints.

Within its own professional network, BQG screened, interviewed and selected professionals from various countries, and submitted a shortlist to the client. A total of 6 experts were selected, seconded with another 2 BQG consultants. The taskforce was led by BQG who was responsible for:

  • The audit of the engineering documentation issued during phase 1,
  • The start-up strategy to successfully manage such a strategic project, involving the production of the first GMP batches by the end of 2013,
  • The overall operational project plan, highlighting out of project, agreed objectives, detailed milestones and detailed planning, key deliverables and reporting structure,
  • Developing systems test plans and related verification tests to convert all systems to a fully functional production plant,
  • Reporting on a weekly basis to the customer, proposing recommendations and managing exceptions.

Results:

Both operational and compliance objectives were successfully met.

As a result of this project success, and upon debriefing with the client, several lessons-learnt were identified:

  • Wherever possible, use important data available at the end of phase 1 (EPCMV). Complete them if necessary.
  • Ensure continuity between audit carried out in phase 1 and those planned in phase 2. Connect user needs with the planned tests, review the work done in the context of critical quality attributes (CQA) for the product and the safety of the patient,
  • Provide a rationale to justify the extent of the tests made in phase 2, based on a risk analysis documented. 

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