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 nine diverse health care businesses: Primary Care, Specialty Care, Oncology, Emerging Markets, Established Products, Consumer Healthcare, Nutrition, Animal Health and Capsugel. 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.
Click on any Pfizer location to find out more about the activities carried out.
The Dublin Sterile Plant's primary focus is the production of Sterile Parenteral vials for human use and Low Bioburden Drug Substances.
The Plant is a global sourcing unit approved to supply product all over the world. Vial size ranges from 2mls to 30mls. Technologies employed at the site include bulk compounding, sterile filtration and filling, freeze drying, protein purification, inspection and packaging. The Drug Substance facility is a small scale versatile conjugation and downstream processing unit.
Currently the site has five operational areas. Two sterile vial manufacturing suites with FreezeDryers, a Bioprocess area, A Biologics area and an Inspection and Packaging unit.
The product portfolio consists of Vfend, Somavert, Macugen and Zithromax.
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.
History
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 2011 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.
People
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.
Facilities
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.
The Pfizer Biotechnology Ireland, Shanbally Plant became operational in 2009. Located at Shanbally, Ringaskiddy, Co. Cork, Ireland, the facility is a phase 2B / 3 clinical trial scale facility to manufacture, purify, formulate and bulk fill mammalian cell culture derived proteins. The facility also serves to establish a strategic biotech manufacturing centre of excellence and is planned to support the rapid development of new biotechnology products.
Construction of the facility began in late 2007, and was a global project, with design undertaken by Fluor Inc. (Greenville, South Carolina, USA), Construction Management by Jacobs Engineering Ltd. (Cork, Ireland) and with equipment sourced from various locations around the globe including US, Europe & Asia.
The plant is utilising a novel operating model, including self directed high performance teams, a low hierarchy organizational approach, Integrated Facilities Management, and implementation of cross functional Product Teams to manage process activities. Cultural attributes that remain essential to all plant colleagues include teamwork, continuous improvement, learning and development, candid and open communications, innovation, and business awareness and understanding.
A learning and development program for operating personnel was developed and implemented during plant construction by colleagues from Pfizer Global Manufacturing, Pfizer Global R&D, NIBRT and FAS. The plant is committed to Operational Excellence through implementation of Right First Time (Six Sigma) and Lean principles such as training of all site personnel in the DMAIC approach to root cause analysis, development of standard work, and 5-S workplace setup among other initiatives.
The facility includes 5,500 litres of bioreactor capacity, over 12,000 square meters of production floor space, and is designed with significant utilization of disposable technology such as bags, filters, tubing and mixing technology, as well as modularization of unit operations. The inherent flexibility that is provided by this design supports the multi-product and variable nature of the potential product portfolio.
The Pfizer Biotech Campus at Grange Castle is Pfizer’s largest investment in Ireland - a €1.8 billion biopharmaceutical campus located in South County Dublin. The development is one of the largest integrated biopharmaceutical campuses in the world and is the only facility in Europe to manufacture biopharmaceuticals, pharmaceuticals and vaccines within the same facility. Over 1,220 full time employees work at Grange Castle which is part of the Pfizer Specialty and Biotech manufacturing network.
Grange Castle is where cutting-edge thinking in biopharmaceutical science combines with state-of-the-art technology and the production expertise it requires to make a real difference to people's lives. The Campus has been designed to the highest architectural quality and aesthetic appeal befitting a dynamic modern setting for the manufacture of breakthrough medicines. It takes its inspiration from a university Campus seeking to reflect the quality and ambiance suitable for a high tech biopharmaceutical manufacturing and development operation.
The Campus manufactures three key healthcare products for the prevention or treatment of serious illnesses including rheumatoid arthritis, inter-abdominal infections and pneumococcal disease in young children. Grange Castle will manufacture products in each of the key platforms of biopharmaceuticals, pharmaceuticals and vaccines.
The campus consists of:
Quality & Compliance
The Quality & Compliance Unit provides resources, expertise and tools to assure that all products manufactured at Grange Castle are safe, pure and effective. All raw material, in-process and final product testing for our products is carried out in state-of-the-art laboratory facilities.
Manufacturing Suites
Suite 1: Vaccines
This facility manufactures monovalent bulk conjugates for Prevenar 13, a vaccine for pneumococcal disease. The process consists of activation and conjugation reactions, buffer preparation and purification of the conjugates.
Suite 2: Vial Fill/Finish
The facility is designed to formulate, fill liquid or lyophilised vials with the capability to terminally sterilise the products and carry out 100% inspections of vials before shipping to packaging facilities.
Suite 3: Syringe Fill/Finish
Syringe Fill/Finish is designed as a multi-product facility for drug product formulation, syringe filling and inspection. The facility uses the latest modular clean room construction and state-of-the-art equipment technology.
Drug Substance Proteins
This facility manufactures therapeutic proteins using mammalian cell culture. The process consists of media preparation, cell culture, buffer preparation and purification of the products. The facility has six 12,500 litre production bioreactors. Currently, the facility produces the drug substance etanercept.
Development and Technical Services
The laboratories allow bench top and pilot scale cell culture and recovery to be carried out as well as conjugation chemistry and fill/finish technology at lab scale.
Engineering and Maintenance
Provides life cycle asset management for the site by implementing strategies that assure best in class performance for compliance and effectiveness. The scope includes all plant infrastructure, maintenance, calibration, automation, equipment validation and utilities programs; as well as all aspects of engineering; civil, mechanical, electrical, water and HVAC.
Warehouse
Provides a support service to the Campus and comprises three distinct areas of responsibility: Shipping & Trade Compliance, Warehouse Distribution and Weigh & Dispense. This team is responsible for all outbound shipments - Finished Product, Samples and Equipment.
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.
The Nutritionals plant, in Askeaton, County Limerick is one of Europe's leading producers of infant and child nutritional products. Established in 1974, this world class facility is one of largest purpose built infant nutritional production facility in the world. The plant produces both powdered formulas and a liquid ready to feed range of products. The plant has an annual production capacity of 50 million kilograms, and more than a third of the company's output goes to Europe - mostly to the UK, with the remainder being shipped to markets in the Middle East, Africa, Asia, Australia and Latin America. The cornerstone of the Pfizer philosophy is one of quality with extensive testing at every stage of production to ensure families get only the best in infant and child nutritional products.
Always a ground breaking company, our Ready to Feed formulae are supplied to Maternity hospitals around the world and are used by many healthcare professionals and new mothers to either supplement breastfeeding, or as the major source of nutrition for newborns. We were also the first company to introduce a whey dominant infant formula that brought the protein and mineral composition in the formula closer to breastmilk. In addition, Pfizer Nutritionals Ireland was one of the first to develop a long chain polyunsaturated fatty acid fortified baby formula. These LCPs play an important part in brain and eye development.
Other unique developments include the application of a physiological fat blend, addition of taurine, nucleotides, selenium and natural carotenoids to our baby formulae - all of which contribute to a baby's growth and development.
The nutritional properties of all products are based on extensive research across a range of disciplines including food technology, biochemistry, nutrition and clinical assessment. Our New Product Development Team also collaborates on important research projects with Pfizer’s Global Research Teams, a number of Universities and Government Agencies, including the National Dairy Products Research Centre.
TopFort Dodge Laboratories Ireland Limited is located in the Finisklin Industrial Estate, Sligo and has been in operation since 1990. The operation employs around 120 persons and manufacturers a range of both modified live (MLV) and inactivated veterinary vaccines. These vaccines are for the protection of the client animal against diseases caused by a specific range of viruses and/or bacteria. The Sligo operation consists of a Biological Manufacturing Site, Warehouse/Finishing Site and Quality function. These facilities were designed specifically for Veterinary Vaccine manufacture to EU GMP standards. The Irish Medicines Board (IMB) carries out regulatory inspections and the operation is cGMP compliant.
The Manufacturing site consists of multiple clean-room/contained sterile process areas, with a central bio-service area. The manufacturing process involves the aseptic cultivation and viral infection of large-scale cell cultures. Bacterial antigens are also produced using advanced fermentation technology. Products are finished on-site for distribution mostly to the European market.
* The European Commission's approval of the Pfizer acquisition of Wyeth was conditional upon Pfizer's commitment to divest several types of animal health vaccines, pharmaceuticals and medicinal feed additives in the European Economic Area or in specific Member States. Pfizer proposed to divest a number of businesses in several national markets and also offered to divest Wyeth's manufacturing facility in Sligo, Ireland. More information on the case is available at: http://ec.europa.eu/competition/mergers/cases/index/m109.html#m_5476
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.
With the acquisition of Wyeth's Fort Dodge Animal Health business, Pfizer is now the world's leader in the discovery, development and manufacture of veterinary-prescription medicines. And, with a richer pipeline of biological and pharmaceutical products, Pfizer Animal Health will expand its leadership role in meeting unmet, veterinary care needs.
Pfizer Animal Health supports veterinarians and food animal producers who work to ensure a safe, sustainable global food supply from healthy livestock. A full complement of prescription and over-the-counter therapies for the family pet or horse also helps caregivers ensure that their companion animals live longer, healthier lives. Our commitment doesn't stop with our veterinary products. Pfizer Animal Health also provides world-class technical support and services to help our veterinary customers prevent and effectively treat animal illness – in more than 60 countries around the world.
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.