Germany shows special facility in FOYA category awards

Three of the five category winners in the 2008 FOYA programme sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX and Pharmaceutical Processing​ magazine were companies located in the German market, albeit in one case with a US parent. The awards come at a time when pharmaceutical manufacturing costs are under an unusual degree of scrutiny. Despite the growing trend to outsourcing, some market observers suggest the industry is still not paying nearly enough attention to inefficiencies in its cost of goods. Noting the plethora of "outstanding"​ projects submitted for this year's awards, ISPE director of business initiatives Scott Ludlum commented: "I believe this indicates the commitment of the industry to build truly innovative facilities that reduce costs and improve operational efficiency"​. The award for Facility Integration went to Germany's Boehringer Ingelheim Pharma, for a new building constructed at the company's R&D site in Biberach. The aim was to integrate all the major functions of pharmaceutical development in a single unit to promote synergies, optimal communication and seamless co-operation across the relevant disciplines. At the same time, maximum flexibility was needed to enable handling of a broad range of product types, batch sizes, potencies and dosage forms. Commissioned in January 2006, the resulting 9,000sq m space encompasses state-of-the-art formulation laboratories, pilot plants for solids and parenterals, GMP facilities to support Phase I-IV clinical trials, and office areas. Bristol-Myers Squibb (BMS) won the Facility of the Year Award for Equipment Innovation, scooping the prize for the Pharmaceutical Development Center of Excellence created on the US company's campus in New Brunswick, New Jersey. A two-phase approach was taken to adapt an existing building in a way that would allow full implementation of lessons learnt as containment and process automation technology were integrated into the operation. Phase One consisted of a state-of-the-art Clinical Supply Operations (CSO) expansion facility, including full containment for expanded oral solid-dose activities and, according to BMS, the most flexible clinical-scale continuous barrier line for sterile products in the US. Phase Two built on the technologies in Phase One, adding further processing space and scale to the OSD clinical operation and a new stand-alone Product Technology Center for development scale-up. IDT Biologika, a German company that performs contract development and manufacturing for new human viral vaccines, was the FOYA winner for Operational Excellence. The company's new Facility for Production of Live Human Viral Vaccines IDT 201 addressed the challenges of incorporating all the relevant operations in a multipurpose facility while avoiding cross-contamination and expensive lead times between manufacturing cycles. Also foremost among the requirements were disposable technologies, room sterilisation procedures and transparency of operations/process flow to satisfy regulatory and client expectations. The result was a total production area of 4,698sq m encompassing two contained manufacturing lines that allow operations to be segregated for the preparation of cells, virus propagation and virus purification using highly efficient technical systems such as fermenters and robotics. The building has capacity for the development and manufacturing of vaccines for Phase I to III clinical trials, as well as for commercial supply. The Process Innovation award went to Pfizer Manufacturing Deutschland at Illertissen, Germany, a strategic site in the Pfizer Global Manufacturing network focused on oral solid-dose forms and containment production. Project NEWCON was launched to expand capacity at Illertissen in the face of growing demand for the smoking-cessation medicine Chantix (varenicline) and to accommodate future demand for highly potent compounds. A novel concept in high-containment manufacturing operations was developed, with the highest possible degree of integrated automation. All the unit operations were located within a single containment module, supported by automation systems without any manual handling. All of the equipment within this module was fitted with suitable barrier technology such as isolators and split-valves. The related process controls were sited in an adjacent room with links to all automation systems and levels supporting processes such as MES (manufacturing execution systems) and laser-guided transport systems. The facility design meant no operator attendance was needed inside the containment suite, nor was any personnel protection equipment required for routine operations. Coming up trumps in the Project Execution strategy was the Swiss-based F. Hoffmann La Roche AG. The company built two biotechnology production facilities to expand capacity for its new anticancer drugs, one of them at the Roche site in Penzberg, Germany. This 'Biologics IV' plant was four stories tall and comprised two highly automated production lines, each with three 12,500 litre fermenters and downstream processing, as well as associated laboratory and office space. The €290 million project was run on an ultra fast-track basis and the new plant was designed, built and brought into operation within three years. The facility is initially being used to manufacture the active ingredient (trastuzumab) for the breast cancer drug Herceptin. Once operating at full capacity, Biologics IV will be able to produce enough active ingredient for another 100,000 Herceptin patients per year. The overall winner of the 2008 Facility of the Year Award will be announced at ISPE's annual meeting in Boca Raton, Florida on 25-29 October.