Five of the six winning facilities in the 2013 ISPE-sponsored Facility of the Year Awards (FOYA), announced during the US ISPE Annual Meeting in November, were biotech-based facilities: Biogen Idec’s new facility won the category for Facility Integration; MedImmune UK’s automation upgrade project won the category for Equipment Innovation; Merck & Co’s vaccine and biologics sterile facility was winner for Operational Excellence; Morphotek won the Sustainability category for a pilot manufacturing plant; and Novartis’s US vaccine and diagnostic flu cell culture facility was winner for Process Innovation and the overall 2013 winner.
Many of these wining facilities illustrate a major therapeutic industry trend away from chemically synthesised blockbuster drugs towards more targeted biological and cell-based products. Not only does this entail new process technology, often involving biological raw materials, cell culture and fermentation, it also changes other aspects of traditional pharmaceutical facility design, such as containment practices.
Novartis’s US flu cell culture facility in Holly Springs, North Carolina, built for vaccine production, breaks with the traditional use of eggs for the method of growing the virus in favour of new cell culture technology. This uses raw materials that are readily available and not threatened by pandemic events. It also uses closed-system bioreactors that reduce the required biosafety level for the manufacturing space.
The Novartis team used creative solutions in other facility operations, notably their approach to ‘containment convertibility’, which allows the facility to operate at BSL-1, -2, and even -3 levels, to reduce costs associated with operating in higher containment modes ‘on demand’.
Greater flexibility
More flexible manufacturing was the key requirement for Biogen Idec’s new facility, constructed at Research Triangle Park, North Carolina for producing treatments for neurodegenerative diseases, haemophilia and autoimmune disorders. ‘The very nature of clinical manufacturing, smaller batch volume requirements, and less predictive outcomes requires an adaptable, flexible manufacturing platform,’ said the company. To fulfill this requirement in the most cost-effective manner, Biogen Idec integrated the new facility into the existing site. It created a hybrid network of fixed and single-use equipment to accomplish variable product demands. The facility features a 100% single-use flow path in a validated closed system.
According to the judges, the technologies employed enable the facility to be a flexible multi-product environment, with lower capital investment, reduced utility demands, and increased speed through the product pipeline, compared with traditional manufacturing methods.
Increased automation
MedImmune, meanwhile, recognising that its existing egg-based vaccine production process would not meet a rapid increase in demand for its influenza vaccine Intranasal, implemented an automation upgrade project for the existing equipment line in Speke, Liverpool, UK. Faced with a lack of commercially available equipment and tight timelines for seasonal influenza vaccine production, the MedImmune team used a system engineering methodology to redesign each discrete processing step into a fully integrated and automated production train.
The team made significant innovations to equipment for automated candling (egg inspection), harvesting, isopropyl alcohol (IPA) spray, decap inspection, and isolation. As a result, the company has seen a 15% increase in yield, a 25% reduction in seasonal labour, an 8% reduction in rejects, and a decrease in waste at every stage.
Sustainability
Sustainability is an increasingly important build criterion and Morphotek, a subsidiary of Eisai, showed its commitment to sustainable design and environmental stewardship when building its pilot plant in Exton, Pennsylvania, US. The plant supports the manufacturing of advanced therapeutic candidates with either cell culture or microbial systems.
The implemented HVAC system was 90% more efficient than a traditional building system. The project team used Building Information Management (BIM) software to integrate the best sustainable decisions into the design process. The company has submitted for LEED Silver Certification to the US Green Building Council.
Built on a brownfield site, its sustainable features include a modular building envelope system with superior insulation; louvred sunshades, a light shelf to maximise daylight exposure while minimising interior heat gain; and comprehensive water and energy conservation plans, including water recycling, a flexible clean steam generation system, and a rooftop solar array for onsite renewable energy.
All these facilities highlight the prerequisites of today’s biotech builds – flexible production facilities, adoption of single-use equipment, greater automation and reduced but more flexible containment areas and more sustainable use of materials and energy.