Pharma Packaging & Manufacturing Awards

ghp Pharmaceutical Packaging & Manufacturing Awards 2016 | 15 Best Severe Disease Pharmaceutical Company - Europe & Most Innovative Immunology Product: Cimzia® PP160010 The mission of UCB Immunology is to deliver value beyond expectations to their patients. They are passionate about providing authentic solutions that address the real-world issues that affect people living with immunologic disorders. The team are dedicated to advancing care for rheumatoid arthritis, while seeking to be leaders in treating psoriatic arthritis and axial spondyloarthritis and to bring sustainable value to patients beyond rheumatology, in immune- inflammation areas such as dermatology and gastroenterology. UCB manufactures a number of therapies for serious neurological and immunologic diseases, including CIMZIA (certolizumab pegol), a biologic drug, specifically a monoclonal antibody fragment that blocks tumor necrosis factor (TNF), a cellular protein that is overly present in people with autoimmune diseases. Unlike other anti-TNF drugs, the CIMZIA molecule lacks a specific binding site, known as the Fc region, which may help reduce side effects. CIMZIA has also undergone a process known as PEGylation, which changes the physical and chemical properties of the molecule to improve drug stability and reduce dosing frequency. CIMZIA is the only Fc-free, PEGylated anti-TNF drug available for patients. UCB adheres to high standards through its Quality System in compliance with Pharmaceutical Regulations (Good Manufacturing Practices) and UCB’s policies and procedures. The Quality System is regularly audited by Health Authorities and takes into account various aspects such as the facilities, the equipment, the documentation, the personnel and the manufacturing process itself. The packaging of the various marketed packs is conducted using dedicates lines in dedicated rooms. Before manufacturing operations, steps are taken to ensure that the work area, packaging lines, printing machines and other equipment are all clean. Gowning procedures are in place for personnel working in those areas. All those measures ensure the delivery of a high quality product. In addition to the existing formulations of CIMZIA, including lyophilized powder and a solution formulation in a pre-filled syringe, UCB recently announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the use of the CIMZIA AutoClicks® Pre-filled Pen in all approved indications. The AutoClicks® device provides a button-free delivery system and a wide non-slip grip that keeps patient hand disability in mind. It has a large viewing window that shows the progress of the injection and it makes a clicking noise both at the start and at the end of the injection, giving patients confidence to know they have received their full dose of CIMZIA. UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. Contact Details Company: UCB Web Address: Address: Allée de la Recherche, 60, 1070 Brussels, Belgium Telephone: +32 2 559 99 99