Fast-track Pharmaceutical Facilities
a report by
Being the first to market has been the key to success in almost every manufacturing industry. This increasingly applies to the pharmaceutical and biotech industries. Pharmaceutical companies want to be able to get their discoveries into production as soon as the last regulatory hurdle in the clinical trials has been passed. “The biotech industry is going to become similar to the electronics industry”, Hans Ole Voigt, General Manager of NNE®, believes. Biotech and pharmaceutical companies know that they will have to jump, almost overnight, from producing small amounts of a compound for a clinical trial to producing industrial quantities of the same substance if the trial is successful. Voigt explains: “A significant proportion of products fail in the late stage of their clinical trials, so companies do not want to commit themselves to building a manufacturing facility until they are sure the product will come to market.” NNE’s solution to the drug companies’ dilemma is modular engineering. This means that capacity can be added when it is needed without disrupting existing operations. “It allows us to expand a facility very quickly. We know that the equipment that is already being used meets the regulatory standards and does the job. More importantly, we also know that the process – the way the drug is being produced – is also correct,” Voigt explains. There is tangible evidence that NNE can deliver at the speed it boasts. It has taken only 18 months to design, build and validate (IQ/OQ) a fully fledged large-scale biotech facility just outside Copenhagen to produce Novo Seven®, a product for haemophiliacs. Drivers and Constraints
• the launch of new products; • adjustment to capacity needs; and • minimising the disturbance. Why is this a particular problem for the pharmaceutical industry? • Products are chemically/biologically novel and frequently require new design of process equipment. This, combined with the regulatory requirements for documented evidence of a facility’s capability to produce a given product, means that the lead time for a new process from laboratory to the production scale is longer than in most other industries. • For the same reasons, a lot of facilities are specifically designed to produce a given product or are limited by regulations to produce one or a few products. This, again, means that shifts in product volumes and mix frequently require costly expansions or reconstructions. • Good Manufacturing Practice (GMP) requirements, including physical protection of the production environment and requirements to keep production under tight and stable control, limit the possibility to modify or reconstruct an existing facility. Modular Engineering
A generally recognised approach to fast-track projects is modular construction. By separating the process plant into modules that can be constructed and potentially tested off site, a lot of the schedule constraints of a construction site can be removed, e.g. space, availability of qualified construction resources, limitations in parallel testing due to utility constraints, test personnel or quality assurance resources, organisational and logistical complexity of a site, etc. While this is definitely a key to large-scale fast-track projects, it is not the all-encompassing solution. The specific constraints and requirements may be in the way of a straightforward ‘ship in the plant in boxes’
Let us look closer at the some of the particular issues that face biotech and pharmaceutical companies, focusing on three factors: BUSINESS BRIEFING: PHARMATECH 2003
Technology & Services
• completeness of modules – if the modules fit to the process functionality, it is easier to include the automation aspects and conduct a more complete off-site testing. Even more important in the long run is that, by applying modular process design, you result in a facility that is...