To maximise new opportunities in biomedical research, and bring more innovative medicines to more patients more quickly, Pfizer has created two distinct research organisations. The PharmaTherapeutics Research & Development Group focuses on the discovery of small molecules and related modalities; and The BioTherapeutics Research & Development Group focuses on large-molecule research, including vaccines.
Pfizer has also developed an enhanced commercial operating structure. Pfizer has eight diverse health care businesses: Primary Care, Specialty Care, Oncology, Emerging Markets, Established Products, Consumer Healthcare, and Nutrition. Each of these businesses is led by an executive with clear accountability for results - from product development following proof of concept to providing access to patients and through to the end of the product's life cycle. The businesses are provided with the resources to pursue attractive growth opportunities and to deliver benefits to all who rely on us around the world.
With this structure, we are able to rapidly capitalise on opportunities to advance our business by increasing support for successful new medicines, forging partnerships with key customers, entering into co-promotion and licensing agreements, investing in new technologies to add value to our core product offerings, and acquiring new products and services from outside the company.
The breadth and range of the new Pfizer business structure is well reflected in our Irish footprint which represents major capital and human resource investments over a large number of years in areas such as Active Pharmaceutical Ingredients, Sterile Injectibles, Solid Dose Pharmaceuticals, Nutritionals, Vaccines and Biopharmaceuticals as well as Global Financial Services.
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Pfizer at Ringaskiddy exports bulk pharmaceuticals, the active ingredients in Pfizer's medication for both humans and animals.
Pfizer was one of the first US pharmaceutical businesses to locate in Ireland and set up its first production facility in Ringaskiddy in 1969 to produce food chemicals, including citric acid and gluconate products. In 1972 the first production plant, Organic Synthesis Plant 1 (OSP1), was constructed to produce bulk pharmaceutical products. The site has grown considerably over the years to meet growing production demands and increase production capacity. The site currently has 3 organic synthesis plants, OSP1, OSP3 and OSP4. In 1990, Pfizer sold its worldwide citric acid business to Archer Daniels Midland.
The site also scales up new products in cooperation with Pfizer Global Research & Development to ensure timely approval and launch of these new products.
In 2007 the Pfizer global Process Development Centre opened a Kilo Technology Laboratory (KTL) on the Ringaskiddy site. The KTL scales up 2nd generation processes coming from the global Process Development Centre laboratories. The KTL specialises in the development and scale-up of novel chemical routes and in the use of new manufacturing technologies.
Our bulk products are shipped from Ringaskiddy to Pfizer plants across the world for finishing and packaging. Each Organic Synthesis Plant is a multi-purpose manufacturing facility capable of producing a wide range of products. Solid and liquid raw materials are added to steel or glass-lined steel-enclosed vessels called reactors. Subjected to temperatures ranging from -50°C to 160°C, pressure or vacuum, and with controlled additions of other raw materials, these mixtures react to form pharmaceutical product. Waste is removed from this product using separation equipment such as filters. Following drying, specially designed mills may be used to grind the material to the correct size. OSP4, the newest facility on-site, contains all standard processing equipment as well as some new technology including extensive use of solids containment equipment, a comprehensive material tracking system and a state-of-the-art control system.
Quality is considered at all stages of processing; all production staff are trained in Good Manufacturing Practices and the Quality Control, Quality Assurance and In-Process Control groups monitor product quality. All raw materials are tested before use and testing during the manufacturing process, as well as final quality control, ensure that all products meet the highest quality requirements before supply to our customers.
Environmental, Health and Safety standards are a major focus area on the site and we actively encourage colleagues' input and suggestions. Waste treatment, waste minimisation, solvent recovery and air emission treatment protect the well-being of colleagues and the environment. The EHS Department continually assesses the way we work and seeks out improvements in all areas of health and safety.
As part of the supply chain and global value streams we have a strong focus on our customers with the goal of being responsive, efficient and cost competitive. Six Sigma and Lean Tools are used extensively across all functions to identify areas of waste and poor flow thus to drive continuous improvement across the site be it in improvements to systems or processes in the areas of robustness or efficiency.
The site started production as Plaistow Limited in 1978 as a contract manufacturer. In 1997 Warner Lambert acquired the site as part of its Lipitor manufacturing capacity expansion. The expansion programme lasted four years and was completed in 2001. In 2000 Warner Lambert merged with Pfizer and all intermediates and final API for Lipitor are now supplied from this site. Lipitor is due to come off patent in 2012 and Little Island has developed a competitiveness strategy in order to compete with the generic market. The Little Island site strategy focuses on delivering a competitive cost in a highly compliant and safe environment.
This strategy is based on excellent performance in the 4 pillars Safety Quality Cost and Supply. Cost competitiveness is driven by introducing best process and engineering technology in an operationally excellent environment.
The Organisational design in Little Island supports this strategy. The introduction of process teams in 2004 gives Little Island a matrix structure supporting each process.
The site currently employees 180 highly qualified and experienced colleagues. The average age of these employees is 38 years and average length of service is 10 years. Over 70% of the colleagues on site have a 3rd level qualification.
The site is situated on 19 acres and contains the following manufacturing areas:
The support infrastructure includes: Warehousing, laboratories (including high containment), utilities building which houses two steam boilers, each capable of generating 13 tonnes of steam per hour, waste water treatment plant which is capable of treating 500 tonnes of processed water each day and an administration building.
The site has special expertise in:
OP1 is a large volume organic synthesis facility which has specialised low temperature and hydrogenation capabilities.
OP3 is a small volume high containment facility and has the only OEB5 API capability in Pfizer. Here we manufacture high potency products which require specialised containment.
The Loughbeg Drug Product plant was built in record time and approved for commercial supply by the Irish Medicines Board in 2000 and FDA soon afterwards. During the first 10 years of operation, the plant has successfully supplied over 40 Billion tablets to over 60 global markets with the highest levels of Quality & Supply Reliability.
The plant is a modern GMP facility with through-wall GMP equipment, gravity flow principles and state-of-the-art equipment installed throughout. A central utilities and technical space provides USP water, steam, chilled water and clean compressed air. A GMP HVAC system operating to ISO14644 with suite segregation, Terminal HEPA filtration & directional airflow. High levels of automation exist in the plant with extensive use of Electronic Batch Record and automated wash-in-place systems for all major equipment.
The equipment in the Plant spans several technologies – Segregated dispensing, High Shear Wet Granulation, Spray Granulation, Roller Compaction, Compression, Direct Compression, Coating, Quality Control Technologies. Advanced technologies are constantly being embraced like Multi-tip tooling, Process Analytical technology & Continuous Processing.
During design and construction great emphasis was placed on creating a safe working environment that is open, bright and pleasant to work in. Extensive glazing was used to allow maximum natural light into the plant. The external design, finish and landscaping were specifically chosen to capture the spectacular harbour views and blend sympathetically with the local environment.
The Loughbeg Drug Product organisation was designed from start-up to be highly agile, innovative, customer-focused and team-based. To enable the performance demanded of a specialist in bulk solid oral dosage manufacturing, ‘layers’ of authority were restricted to 3, including the Site Leader. True leadership is expected and required of all colleagues. Recruitment and selection processes therefore have been designed to identify in prospective colleagues the aptitude and attitudes necessary to thrive in such an environment.
All HR policies and practices are coherent with the design principles around which the organisation is built. A commitment to learning and development is reflected in the common practice of face-to-face feedback as well as a commitment to role enrichment and opportunities to learn through stretch projects and assignments. Within manufacturing as an example, the Tablet Technician role encompasses operations, maintenance, in process control testing, writing of GMP documents, continuous improvement and budgeting. Everybody being a leader is also reflected in self-managed teams and 100% of colleagues being salaried rather than hourly-paid.
Grange Castle is Pfizer’s largest single investment in Ireland, a €1.8 billion biotechnology facility located on a 90-acre site in South County Dublin, with buildings and facilities extending to more than one million square feet. The development is one of the largest integrated biotechnology plants in the world and is part of the Pfizer Specialty Biotech manufacturing network. Construction of the facility commenced in 2000, and the site was licensed and officially opened in 2005. Principal manufacturing technologies include large-scale mammalian cell culture, protein purification, vaccines conjugation, and aseptic syringe filling.
The site manufactures biological active ingredients, which are used in parenteral products for the treatment of rheumatoid arthritis, psoriasis and ankylosing spondylitis, and in vaccines for the prevention of pneumococcal disease. The site also manufactures the finished vaccine drug product in pre-filled syringes. As well as commercial operations, Grange Castle is licensed for, and has manufactured investigational medicinal products for use in clinical trials.
Manufacturing at Grange Castle is supported by extensive Quality Control laboratory facilities, which also provide support to other global Pfizer manufacturing sites. Site central utilities support manufacturing through the provision of essential services such as water purification, heating, ventilation and air conditioning, management of plant infrastructure, and calibration and maintenance. Expansive on-site warehousing provides both ambient and cold storage for raw materials, intermediates, and finished products, as well as facilities for the weigh and dispense of materials for use in manufacturing. Administrative support comes from other departments such as human resources, business technology, organisational learning, regulatory affairs, occupational health, and finance.
Grange Castle has significant development operations, and benefitted from a major expansion of its development facility in 2007. This facility houses state-of-the-art pilot-plant, laboratories and equipment for the development of processes for production of many different types of biological drugs, including proteins and vaccines. In addition, Grange Castle is also home to scientists from Pfizer’s biotherapeutics research organisation working on a number of drug discovery and optimisation projects in collaboration with other Pfizer research and development sites and various partners.
All of Grange Castle’s manufacturing processes are subject to rigorous control to assure the quality of processes and products. This includes a comprehensive Quality Assurance system coupled with a series of stringent Quality Control tests to ensure that each batch meets its requirements for safe and effective patient use. In addition, the highest standards of environmental performance and a deep commitment to safety and corporate responsibility are part of the culture at Grange Castle. In 2011, Grange Castle joined with the other Pfizer Ireland Pharmaceuticals sites to win the prestigious Green Manufacturer Award in Ireland, and in 2012 Grange Castle won The Chemical & Pharmaceutical Manufacturer Award for its submission to the National Irish Safety Organisation safety awards scheme.
Pfizer Newbridge was established in Co Kildare in 1992. Since then, successive expansions have seen the site grow from 40 to over 120 acres in a facility of over 1,000,000 sq ft making it one of Europe's largest manufacturers of solid dose pharmaceuticals. Today, Newbridge is a centre of excellence for the global and regional supply of established products as well as a manufacturer for new and innovative therapies that are currently in the research and development pipeline.
Since 2006, over €350 million has been invested in Newbridge to expand its development and manufacturing capabilities. The facility currently supplies over 80 product formulations across a wide range of product categories including central nervous system, hormone therapy and oral contraceptive to more than 100 markets around the world.
Good environmental and energy management forms an integral part of how Newbridge operates and is an indistinguishable element of the search for excellence in every area of operations. Pfizer Newbridge has developed its Environmental and Energy Management Systems based on the requirements of ISO system standards. On an annual basis SGS Ireland Ltd. audit and independently certify and verify that the Pfizer Newbridge environmental and energy management systems comply with the requirements of ISO14001 standard, EU Eco-Management and Audit Scheme (EMAS) and IS393 standard.
The systematic ISO 14001 approach requires an organisation to take a rigorous look at all areas where its activities have an environmental impact. The Pfizer Newbridge Environmental Management System has been independently certified as complying with the requirements of ISO14001 standard since 1998. Building on the success of previous certification to the requirements of ISO 14001 the Pfizer Newbridge environmental management programme has been verified as complying with the requirements of the Eco Management and Audit Scheme (EMAS) since May 2004.
In March 2006 Pfizer Newbridge signed an agreement with Sustainable Energy Ireland (SEI) to put a certified energy-management system in place. Following through on this commitment, in June 2008 the Newbridge Energy Management System was certified to IS 393, the Irish Standard for energy management. This Energy Management System puts a structure around how the Newbridge facility manages its energy and helps to identify and minimise the sites energy consumption. The aim of the IS393 standard is to establish a systematic approach for continuously improving efficiency of energy usage.
Pfizer Healthcare Ireland (PHI) brings the prescription medicines of Pfizer's industry-leading pipeline to patients and GPs in Ireland. It is part of Pfizer’s Worldwide Biopharmaceutical Businesses (WBB), and four of WBB’s business units are represented in Ireland - Primary Care, Specialty Care, Oncology and Established Products. Each global business unit operates as a totally integrated enterprise, spanning clinical development (post-proof-of-concept), commercial development, medical, marketing, sales and post-loss-of-exclusivity management.
PHI is the market leader in Ireland, bringing a range of medicines and vaccines to Irish patients across a diverse range of therapy areas and conditions. The company’s mission is to deliver innovative, life saving, and life enhancing medicines to patients, while partnering with others to grow the business and develop sustainable solutions. We seek to earn trust and be a valued corporate citizen, through the actions, pride, passion and performance of our people.
The business believes in “Working together for a healthier world” and invests heavily in a range of partnering activities in Ireland to realise that goal. Such activities include patient information campaigns, advocacy group support, health screening services, health policy initiatives, as well as local community support.
Pfizer’s Consumer Healthcare Business (CHB) is among the largest over-the-counter (OTC) healthcare products companies in the world. CHB develops, manufactures and markets leading non-prescription medicines, vitamins and nutritional products. CHB works to continually bring new and better solutions based upon cutting-edge science to market that help consumers around the world support their health and enhance personal well-being.
CHB drives growth through major global brands including Centrum®—the #1 multivitamin; Caltrate®—the #1 calcium supplement; and Advil®—the #1 ibuprofen analgesic brand in the world. The division’s major categories consist of Pain Management, Nutritionals, Respiratory and GI-Topicals, and include these trusted brands:
The Dublin Treasury Centre (DTC), with a presence in Dublin since 1991, is Pfizer’s global treasury centre outside of the US. The DTC provides in-house banking and corporate treasury services to all of Pfizer’s international affiliates including Intercompany loans and deposits, various foreign exchange hedging programs and multilateral netting. In addition, the DTC works closely with Treasurers in NY to manage Pfizer significant investment portfolio and to provide support for other corporate treasury initiatives.The DTC currently employs 18 colleagues who manage the end to end treasury function; from front office to credit, settlement, financial control/compliance & IT.
GFS-E is the primary shared financial services centre for Europe and is a unit of Pfizer Global Financial Solutions (GFS). GFS is a network of centres across the globe working to centralise and standardise the company's financial support, streamlining processes to create efficiencies, improved effectiveness and control environment. Following the establishment of a financial shared services pilot in Memphis, Tennessee, in 2002, a second financial shared services location was established in Dublin, Ireland, to service the European markets - GFSS Europe Financial Shared Services Centre (GFSS Europe). GFS Europe currently supports 16 European markets: UK, Spain, Denmark, Finland, Sweden, Norway, Switzerland, Netherlands, Luxembourg, Austria, Portugal, Ireland, France, Italy, Germany and Belgium.