This tour will visit Alexion College Park's Operations headquarters in Blanchardstown, Dublin, including its new BDS Biologics Manufacturing facility which is ongoing and due to commence PPQ batches in 2019. Alexion College Park also incorporates fully operational capabilities including a Secondary Packaging plant, QC Laboratories, QA release and Global Operations functions.
Alexion is significantly expanding its operations in Ireland both in Athlone and in Dublin - the College Park BDS Plant is the Company's only biologics manufacturing facility outside the United States. This € 455 million, four-year project in College Park, Dublin and is expected to create approximately 200 additional full-time jobs on completion, which will bring Alexion's total workforce in Ireland to almost 500 employees. This facility is a 20,000m² facility with 4x 22,000L Bioreactors and associated purification operations.
Helsinn Birex Pharmaceuticals (HBP) is a part of the Helsinn Group. Helsinn is a privately-owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland, USA and China with ca 700 employees. Founded in 1976, the company has become known worldwide for its unique business model focused on the licensing, development and commercialisation of innovative pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas with particular focus on cancer supportive care and cancer therapeutics.
HBP first opened its green site facility in Mulhuddart, West Dublin in 1997 initially as a manufacturing plant for oral solid dose forms and since then has broadened its scope to become the center for Global supply of Commercial products for the group serving all major markets worldwide including EU, US, and Japan. In 2010 the company commenced Chemistry, Manufacturing, and Controls (CMC) development activities with successful launch of its first product in 2014 in the US and in 2018 the company opened a new high containment suite for small scale processing to be used for development and in the future manufacture of new products.
These capabilities are backed up with all necessary support functions including Quality, Analytical, Engineering, etc., and in addition, fully operating drug safety unit and pharmacovigilance activities.
Currently Helsinn Birex employs almost 200 people and is committed to operating to the highest standards of Quality and Sustainability. It has built a consistently strong track record in GMP compliance , employee wellbeing and is a regular winner of EHS awards including
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 Speciality 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.
Grange Castle has significant development operations, and the 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.
Takeda Ireland is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TPC), the number one pharmaceutical company in Japan and one of the world’s top 100 companies.
In 2002 Takeda Ireland - Grange Castle became Takeda's first API manufacturing operation to be located outside Japan and an important strategic site established to produce API for global markets. It is a modern, automated multi-purpose facility with a high focus on Quality and Safety. Grange Castle produces APIs for the treatment of Diabetes, Oncology, Insomnia, Weight loss, Acid related disease, Bipolar disorder and Hypertension.
In 2016 we constructed a new standalone, high containment, state of the art production facility dedicated to the manufacture of our oncology product NINLARO, a treatment for patients with multiple myeloma, for global markets. Construction of this facility commenced in March 2017 with full production targeted for early 2019.
In 2017 a further additional investment was approved for our Grange Castle site to construct a dedicated bioprocessing manufacturing facility to produce Takeda’s first regenerative medicines product including high standard clean room operations (Grade A, B) by 2020. The construction process includes state-of-the art plant delivery through the use of modular building techniques which allows fast facility delivery and limited on-site construction activities.
Takeda Ireland – Grange Castle draws on the expertise of its world-class people, equipment and systems to meet the challenges of competing in our leading-edge markets. With a best-in-class quality and safety record, we have also focused on operational excellence with all of its employees trained in LEAN manufacturing techniques.