The fill finish facility is used for the aseptic filling of biologics including enzyme replacement therapies in the Genzyme rare disease portfolio. The filling and lyophilisation capacity at the site places the Waterford plant at the heart of the Genzyme supply chain. The packaging facility has sachet, vial and bottle packaging lines. An extensive range of product testing and release to market is performed with distribution to over 70 countries worldwide.
The site has invested in state of the art infrastructure and technology, reflecting the niche nature and high value of the products produced there. It also has clinical trial manufacturing capability. The pilot scale facility provides product development, technical transfer and process trouble shooting capability. The Quality Systems have been audited by leading regulatory bodies from around the world and Genzyme Ireland has an excellent quality and compliance track record. Operational excellence is a key site enabler and continuous improvement processes are grounded in best practice and involve those closest to the operations.
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over thirty years. It accomplishes its goals through world-class research and with the compassion and commitment of its employees. With a focus on rare diseases, the company is dedicated to making a positive impact on the lives of the patients and families it serves. Genzyme’s portfolio of transformative therapies, which are marketed around the world, represents groundbreaking and life-saving advances in medicine.
As a Sanofi company, Genzyme benefits from the research and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients.
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Genzyme are constructing the modern high-tech production line to fill the familiar glass vials that contain pharmaceuticals. This is a tightly controlled industrial process involving the removal of pyrogens, freeze drying. These processes are described and the chemistry behind them is examined.
Sterilisation is the name given to the process that eliminates or kills all forms of micro-organisms and their spores. This is, in practice, difficult to achieve. This lesson explains why the methods used depend on the material being sterilised and on the type of organisms present.
This lesson discusses vitamin D and its function in maintaining human health. Its sources are discussed and its various vitamers are identified. The impact of a deficiency and the conditions resulting from deficiency, such as rickets, are discussed. RDAs are also explained. The functions of parathyroid hormone, the symptoms of hyperparathyroidism and hypoparathyroidism, the effect of chronic dialysis on calcium and parathyroid hormone levels and the use of Doxercalciferol as a control are also discussed.
This lesson discusses the function of the thyroid gland and of the hormones it produces. The different kinds of thyroid cancer are summarised as are the main treatment options. Conditions such as hypothyroidism and hyperthyroidism are discussed and the relationship between the pituitary and the thyroid is also outlined.
A major problem associated with organ replacement is the body’s own reaction to the foreign tissue. The risk of rejection can be greatly reduced by matching donors and recipients prior to transplantation.
Hurler syndrome, also known as MPS-I, is a genetic disease whose effects on an individual are varied and severe. It is caused by an error in the production of a single enzyme.
Skin tissue can now be cultured and used for the treatment of skin damage such as extensive burns.