Project Delivery Partners have been working in partnership with Lonza at their Visp site in Switzerland since 2019. We are very fortunate to be involved in several high profile and fast track projects supporting with CAPEX Management, Start UP and Digital CQV services.
Notable our most challenging, but equally rewarding in term of speed to market, was the hypersonic delivery of the Moderna mRNA COIVD vaccine facilities where PDP supported with Project Management, Start up, Qualification and end User support with Engineering batches. The facility comprises of a number of Production suites, Clean Utilities and process mRNA equipment.
From ‘shell to shot’ in 8 months, this was truly a remarkable project which challenged our traditional CAPEX delivery model, our ways of working, our procurement and sourcing approach, supply chains and interestingly the way in which Projects and Operations co-existed, worked together safely to deliver a GMP operational facility and process including regulatory approval in a phenomenal time frame.
PDP are grateful to continue our collaborate with Lonza on multiple projects in Switzerland including Vaccines, Mammalian, Bioconjugates and Drug product facilities. We are supporting our Client with Project Management, CQ Management and delivery and with the implementation of a new digital CQV platform which is set to revolutionise the industry and in particular the Qualification of Process equipment.
From a CQ perspective we provide full services including:
- Documentation Management
- Development of URS, GMPRA and DQ
- CQ Protocol Preparation
- FAT Support
- Change Management
- Deviation Management
- Support Mechanical Completion
- CTOD and VTOD Review and Approval
- Start Up Safety including PTW, PSSR and LOTO activities
- Start Up and Shakedown
- SAT Coordination and Oversight
- IQ, OQ and PQ execution
- Support Handover
- Support End User with Engineering Batches
We are working on a variety of Biotech Process and Utility Equipment including;
- Clean Utilities including Purified water, Clean Steam, WFI generation systems and associated loops
- GMP Clean Rooms
- Single USE and Metallic Upstream Bioreactors
- Single USE and Metallic Downstream Processing Equipment
- Fill Finish Equipment
- Highly automated process using Delta V and MES
Project Delivery Partners has significant experience in delivering CQV on multimillion dollar fast track projects in Europe, the USA and in Asia.