Internationally active in pharmaceuticals and diagnostics
A key activity for Sanquin is contract manufacturing. This involves using our facilities to manufacture products for third parties who provide the raw material. This enables us to achieve economies of scale, so that we can produce plasma medicines at competitive prices – a requirement in today’s international market. The Dutch market also benefits, as plasma products made using Dutch plasma can be made cost-effectively.
David Lowndes, Senior Vice President Supply Chain Management Shire. “Sanquin is an important partner for Shire thanks to its experience and expertise in the manufacture of the human C1-esterase inhibitor Cinryze®. This enhances our ability to meet the needs of patients with hereditary angio-oedema. Thanks to our proven expertise in selling this product, Cinryze has the potential to develop into one of the most important products in Shire’s portfolio.”
Sanquin has worked with the biopharmaceutical company Shire sincelate 2013, and produces the plasma medicine Cinryze from American plasma in cooperation with Shire. This partnership provides very effective medicinal products, available for a considerable time in the Netherlands, to patients with hereditary angio-oedema around the world. The demand for Cinryze continues to grow, consequently, Shire and Sanquin are looking for ways to increase production. The existing joint venture between Sanquin and Shire intensified in 2015, with Shire giving Sanquin access to the manufacturing technique used to make Cinryze. This step strengthened the global availability of an important medicine on which patients throughout the world rely. Shire is involved directly in the improvements related to compliance.
In the context of its collaboration with the US pharmaceutical company Baxter, Sanquin increased its manufacturing capacity for processing Baxalta plasma in 2013 and 2014. In 2015, Sanquin started the preparation of albumin and immunoglobulins that Baxalta will, among other things, use to treat burns and diseases when defence against infections or the body’s own cells has been disrupted.
Quality at Sanquin Plasma Products
Sanquin’s manufacture of semi-finished products and medicines for third parties (CMO production) is undergoing such rapid development that the manufacturing requirements also necessitate the further professionalisation of various manufacturing processes, such as the supply chain, documentation, quality control and product release. In the autumn of 2013, Sanquin received a warning letter from the US Food and Drug Administration (FDA). In it, the FDA pointed out bottlenecks in the medicine manufacturing process for the US market. Consequently, a Compliance Enhancement Programme was launched immediately to improve compliance with US regulations. During a meeting with the FDA in April 2015, the FDA expressed its confidence in the progress Sanquin is making on improving compliance in manufacturing medicines for the US, and the speed with which quality awareness is developing. An FDA-approved party, Quantic, was appointed to supervise manufacturing at Sanquin and CAF (the Belgian plasma fractioning facility whose sole shareholder has been Sanquin since 2015). Regular meetings on further progress were scheduled with the FDA in 2015. The FDA will return to carry out another check in 2016. The continued improvement of processes (both administrative and technical) throughout the entire organisation will remain a key area for attention in the years ahead.
Immunomonitoring is the analysis of a patient´s immune status in its broadest sense. It includes serological determination of specific antibodies and inflammatory mediators, determining antigen-specific immune cells, HLA typing, and the amount of medicine present in the blood (such as biologicals). Immunomonitoring tests are becoming increasingly important as the number of therapies targeting the immune system grows.
Sanquin professionalised its services in this field in 2015. Focussing a section of our website on these services has increased the visibility of a broad range of tests, creating a single point of contact where customers can ask specific questions. A range of Sanquin experts then examine how best to answer the questions, and which types of tests to use. New tests are developed to ensure a full range of possibilities.
Biologicals testing on the rise
Biologicals are therapeutic proteins which help inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. However, some patients develop antibodies against these proteins, causing them not to work or to work less effectively. Sanquin has developed tests to measure the amounts of both biologicals and potential antibodies against biologicals in the blood. This allows more tailored treatment using these very expensive medicines. Sanquin performs these tests itself, but also sells them to third parties. Our diagnostic services for patients treated with biologicals increased by 30% in 2015. A significant proportion of this growth is for patients treated abroad (in Europe, North and South America and Asia).
The first more affordable versions of biologicals were marketed in 2015: biosimilars. They are equally effective, and in 2015 Sanquin announced it can measure them accurately as well. Due in part to the introduction of biosimilars, we have been approached by a growing number of pharmaceutical companies to help support their phase IV (post-marketing) studies.
Sanquin has also been cooperating with a number of international research consortia working on biologicals since 2015: the British PSORT, which studies biomarkers for the treatment of psoriasis, and the French MAGE, which studies therapeutic drug monitoring (TDM) for biologicals.