Best Way to Ensure Biomanufacturing Plants Have Quality? By Design
Since 2010, Lonza has been working with GSK on designs for a £370m ($574m) biomanufacturing facility in Ulverston, UK. BioPharma-Reporter asked Michael Cicio - VP Operations at Lonza Biologics what he considers are the three most important design issues to consider when constructing a new plant.
“Compliance in room classification design, validation and operation,” is the first he said, followed by “simplicity of design in order to allow for quicker validation.” Third was “flexibility of design - a facility needs to be able to accommodate for various throughput levels, equipment storage and process requirements.”
We put the same question to M+W – another firm that specializes in the engineering and construction of bio-facilities. David Estapé, Technology Manager for Biotechnology told us design needs to be small scale, flexible, and lean to ensure efficiency, especially as there is a current “trend to small facilities and decentralized production.”
Both Estapé and Cicio also told us new biopharmaceutical technologies – better bioreactors, more efficient processing systems – and the growing acceptance of disposable systems are also impacting facility design, and driving the need for greater flexibility.
Michael Anderson - Executive VP and COO of Total Facility Solutions (TFS) – also suggested that design principles are changing, telling us he has witnessed the simplification “process design [methodologies] to produce less and less construction documentation.
“This is partly due to the speed-to-market demands of the industry to initiate construction as soon as possible to maximize patent protection of the products.”
Rebuild or Restructure?
In June, former GSK Director of European External Supply Quality Peter Murray told delegates at the Global Pharmaceutical Contract Manufacturing (GPCM) Event in London that it may be better to rebuild old and problematic plants than to try and fix them.
This is not an approach seen in the biopharmaceutical sector so far according to TFS’ Anderson, who told us “due to the high capital investments in significant biologics manufacturing facilities, ‘knock downs’ are not common.”
“More typically, facilities are re-purposed for new product campaigns or upgraded to improve operating efficiencies.” However, he added “older plants face continuous challenges maintaining cleanliness levels or protection against cross-contamination excursions.”
A similar view was taken by Lonza: “Facilities are adapted or modernized within their current footprint to meet the changing needs of production” and “often there is a significant portion of infrastructure that can be repurposed for the new design.”
However, Cicio continued: “If a structure was to be demolished it may be due to what the facility made before and what the plans are for the new facility.” For example, “changing an antibiotics facility to a biologics facility would require full demolition and restructuring of an existing site.”
