Philippe Muyters opens GMP facility Q-Biologicals, SEPS Pharma and VIB

6 March 2015

​Unique expertise and GMP infrastructure increase international appeal of Flemish biotech sector

This afternoon, the Flemish Minister for Work, Economy, Innovation and Sport, Philippe Muyters opened the new GMP facility of VIB, Q-Biologicals and SEPS Pharma: “Flanders is internationally renowned for the testing of new candidate drugs on healthy volunteers and patients. We are among the global leaders, with the largest number of clinical studies per inhabitant. The step just prior to the clinical studies - particularly the clinical production of candidate drugs - is now also available in Flanders as a result of combining the expertise of Q-Biologicals (clinical production of candidate drugs, particularly biologicals) and SEPS Pharma (clinical production of final dosage forms in which these candidate drugs are formulated) in the brand new GMP facility. This GMP infrastructure was achieved through a substantial investment from VIB, Q-Biologicals and SEPS Pharma.”
Need for GMP infrastructure
New drugs are produced for clinical studies under strictly controlled conditions: not only do they need to be effective, sterile and sufficiently stable; they also need to be free of contaminants. The production process must be reproducible, so that the same quality can always be guaranteed. Furthermore, the production process must be fully traceable and all the steps of the process must be described. This is only possible if you have access to an adequate GMP production infrastructure (Good Manufacturing Practice) linked to a quality system.
Johan Cardoen (Managing Director VIB): “VIB is committing to its role of supporting the Flemish biotech sector through a substantial investment in this new GMP infrastructure. We are convinced that the fact that SEPS Pharma and Q-Biologicals can work under these very tightly controlled conditions is a trump card for the Flemish biotech industry and will result in new investments in our sector in the long term.”
Q-Biologicals and SEPS Pharma have complementary expertise
SEPS Pharma and Q-Biologicals are two young biotech companies located in the Bio-Incubator of VIB on the Ghent Technology Park, with both playing a specific role in the development of new drugs: production and purification of biologicals on the one hand and pharmaceutical product development of candidate drugs for various administration routes, combined with the clinical production of these developed dosage forms, on the other hand. By working together, they provide unique combined expertise to the (Flemish) biotech sector.
Annie Van Broekhoven (CEO Q-Biologicals): “Thanks to the investment and continued support from VIB, we have been able to build up this GMP facility and we are now able to produce biologicals for clinical trials. This allows us to support upcoming and established players in the Flemish biotech sector in the production of their candidate drug, which will definitely provide significant added value for Flanders. Today, we are also announcing our collaboration with SEPS Pharma - our neighbors in the VIB Bio-Incubator - active in the field of formulation and filling. Thanks to the GMP infrastructure and the combined expertise of our companies, we are able to offer a total package to the biopharmaceutical sector. This can definitely shorten the development path of new drugs and result in new innovations.”
Yves Gonnissen (CEO SEPS Pharma): “We are particularly proud that this investment has become a reality and that our new GMP infrastructure is now in use. This will result in an extremely important expansion of our development services with regards to candidate drugs. I wish to emphasize that this investment could only be achieved through the strong support from VIB at various levels, for which we offer our sincere gratitude. We are also particularly pleased to announce today - together with our neighbors at Q-Biologicals - the expansive cooperation regarding production and pharmaceutical product development of biologicals.”
Expertise Q-Biologicals: production of “biologicals”
“Biologicals” include a wide range of biological substances. These are often medical products such as vaccines, therapeutic proteins or antibodies that are used in the treatment of diseases or form the basis for diagnostic tests. With 16 % growth per annum, the production of biologicals is a market exhibiting strong growth. The total global production amounts to more than 2 billion Euros per annum. The Flemish biotech cluster also develops an increasing number of biologicals. Many companies outsource the production and purification of these proteins to third parties. The reason for this is the high standards set for expertise and infrastructure. Q-Biologicals produces and purifies such biologicals.
Expertise SEPS Pharma: pharmaceutical product development and clinical production of candidate drugs
SEPS Pharma focuses on innovative pharmaceutical product development, in particular the formulation and analytical development of liquid and solid dosage forms for oral, parenteral, nasal and buccal administration. The company is specialized in increasing the biological availability and in the development of dosage forms for controlled release of candidate drugs. SEPS Pharma has a strong and wide knowledge base regarding innovative formulation technologies for candidate drugs with specific biopharmaceutical problems such as low solubility and/or permeability.
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