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Within R&D Plasma my group is responsible for the preclinical development of novel plasma-derived therapeutic protein products as well as the life cycle management of the established plasma product portfolio, focusing on regulatory, production and marketing topics. One of our key objectives is to ensure that Octapharma is optimally using every drop of its precious raw material – human plasma.
I completed my PhD thesis on factor VIII characterisation with Octapharma in 1998, and have been employed with the company since then. In the characterisation of plasma proteins one elucidates the structure of the protein. The goal in purification is to separate and protect the specific protein while optimising product yield. The integrity of the protein has to be maintained throughout the process because the resulting purified plasma component will, ultimately, reach our patients. The protein has to be pure, active and as close to its native state in plasma as possible. Using various analytical techniques, including chromogenic and potency assays, we analyse and profile the structure and properties of the purified plasma protein.
There are so many proteins found in plasma, with different concentrations, molecular weights, half-lives and stabilities. This is a fascinating field and I am proud to be in a position that combines science with the management of people. It is very rewarding to work together on scientifically challenging areas in order to develop products that save lives. We can make a real difference to quality of life, for example by developing new applications for existing products to improve convenience and allow patients to be more independent. This is especially important when it is considered that many of our patients need lifelong treatment.
One way of improving convenience for patients is by developing a product with a reduced volume for intravenous administration, or a subcutaneous application for an existing intravenous product. When embarking on such a project, there are various factors to consider. The formulation of a subcutaneous product must be more concentrated compared with the intravenous product because one cannot infuse a large volume subcutaneously. Therefore the protein must be stable in higher concentrations. We must also ensure that the active ingredient is not degraded when applied subcutaneously.
In March 2016 we held the ground-breaking ceremony for our new R&D centre in Vienna, which will be home to my R&D Plasma group and the Clinical Research & Development (CRD) department. The building has a net floor space of 4,500m2 and consists of six floors with 13 laboratories (1,600 m2) and 39 offices (1,200 m2), accommodating around 100 people – 60 from R&D and 40 from CRD. We have been in our current location for 18 years, so the new building had to be planned with a long-term view considering what the future needs will be, especially as Octapharma continues to grow. The investment in our new home shows Octapharma’s long-term commitment to R&D.