cGMP biotech plant for drug development and pilot manufacturing

As part of its transformation from a chemical company to a global, patient-centric biopharma company, UCB Pharma built a cGMP biotechnological pilot plant – including development laboratories – on its site in Braine-l’Alleud in Belgium. NNE provided design and EPCMV services, and helped the customer set up a risk and science-based verification system.

The overall purpose of the project was to provide clinical manufacturing and development capability for mammalian cell culture-based protein products, utilising a “template” process that covers most products foreseen by UCB’s global technical development group.

The new facility contains a pilot plant (up to 2,000L bioreactor scale, including both upstream and downstream operations), a process development laboratory (for upstream and downstream processing) and a stand-alone utility building. With the facility, UCB Pharma aims to speed up availability of biotechnological drugs for serious illnesses in the central nervous system and immunological problems, concentrating on pilot projects and delivering products for clinical trial activities.

The first stone was laid on 4 June 2010, and final handover took place in February 2013. NNE supported UCB under an engineering, procurement, construction management and verification (EPCMV) contract, from detailed design through construction to verification.

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Patient safety first

Investing in this new facility is a central part of UCB’s patient-centric approach to business. To safeguard patient centricity, the project is based on risk and science-based verification principles according to the ASTM E2500 as well as the ICH guidelines Q8, Q9 and Q10. The application of the ASTM E2500 verification approach may seem difficult to handle at first. However, the tools and principles of risk assessments and verification of vendor-prepared tests are well known and easy to implement.

As a result of the verification methodology, duplication of tests is avoided and focus is intensified on the areas with the highest risk to patient safety, which is a key element of the verification approach. Furthermore, flexibility in project execution is increased by elimination of the non-value-adding dependencies between installation, operational and performance qualification. At the same time, resources are used more efficiently and the quality risk assessment process ensures that focus is directed towards the real quality issues.

Quick facts

Customer

UCB Pharma S.A.

Country

Belgium

Size

Total area approx. 8,500 m2

Project duration

Jun. 2010 – Dec. 2012

Total investment cost

USD 73 million

Services provided

Conceptual design, basic design, detailed design, engineering, procurement, construction management, verification (according to ASTM E2500)