Fast-Track Pharmaceutical Facilities
Technology & Services
Fast-track Pharmaceutical Facilities a report by
NNE
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
Fast-track Pharmaceutical Facilities a report by
NNE
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