May 19, 2014
During the World Stem Cells Regenerative Congress 2014, Chemelot Campus announces its first step in the realization of the so-called Regeneration Street in Sittard-Geleen (NL), comprising 50,000 m2 of world-leading research, development, manufacturing and innovation in Regenerative Medicine.
The first step is a fully equipped and serviced state of the art building, simply called Regeneration Street nr.1.This will be home to ATMP Manufacturing companies, Research Institutes, a Contract Manufacturing Organization and startups in the fields of Regenerative Medicine and Tissue Engineering. It offers an advanced facility, open for all RegenMed companies, regardless of what stage of development they are in.
Flexible set up
Regeneration Street nr.1 offers flexibility in set up and scalability through an innovative architecture of the interior. The building has a total ground floor size of 2,400m2 with 750m2 clean room facilities.
Regeneration Street nr. 1 is already up and running and capacity will be expanded by Q4 of this year.
Pharmacell as Contract Manufacturing Organization
PharmaCell plays an important role in the realization of Regeneration Street nr. 1. The company rents the facility, using it as the production facility for its larger scale CMO activities. Amongst other products Pharmacell manufactures the Tigenix’ ChondroCelect® product.
PharmaCell will also act as a Service Provider for the facility to ensure that required QC controls are met, which offers other tenants of the facility a significant advantage in time and cost to get their manufacturing up and running according to the highest standards.
New research institute
A significant part of the facility will be rented to the Chemelot Institute for Science and Technology, Chemelot InSciTe. One of the goals of this new research institute is to develop smarter biomedical materials to be able to sustain the ever more expensive health care.
Regenerative Medicine is a new dimension in the Pharma world. Its goal is to invent, build and supply innovative solutions by tapping into the healing powers of our own bodies through the use of autologous or allogeneic cells, in some cases combined with biomaterials that serve as scaffolds or delivery mechanisms for the human cells. The aim is to maintain health care at reasonable costs by moving from a palliative, disease controlling health care system to solutions that actually cure the disease, apart from prevention. This development offers enormous market opportunities for Regenerative Medicine. However, the scientific, technological and definitively the manufacturing developments are still in their infancy. Large progress can be made in terms of cost reduction and production efficiency. Especially because the product that is being manufactured is a living entity, often a patient-specific product. By definition this product differs from patient to patient. These variations require a unique set of skills to define product specifications and to design manufacturing processes that deliver a consistent quality. The Regenerative Medicine industry is estimated to be a $900M industry in 2013. The industry is currently at a tipping point and is positioned to hit its next phase of growth in the coming years. An important indicator that for that is the number of clinical trials that are currently going on: 2,500 disruptive RegenMed-based clinical trials right now, of which over 500 in late stage. With today’s success rate of about 60% from phase III to market approval, this means we can expect over 300 highly innovative products to enter the market. And this brings with it an entirely new set of challenges.
Chemelot and Regenerative Medicine
Amongst others these challenges concern optimizing and scaling up manufacturing processes, expanding production capabilities and facilities. This is where Chemelot Campus comes in. With its unique expertise in high tech and R&D infrastructures, scalable production plants and Good Manufacturing Practices, related to innovative industries, Chemelot Campus is committed to play a defining role in the coming years. This commitment is stimulated by the fact that two of the three approved ATMPs (Advanced Therapy Medical Products) in Europe are produced in the (Dutch) province of Limburg, where Chemelot Campus is located. Chemelot Campus is accelerating the commercial manufacturing of living human cells for medical treatment, the production of living tissue and (in the distant future) completely new organs. Globally there are over 700 companies with patents and innovations in this field. Many of these will need dedicated manufacturing facilities with skilled and trained employees and the appropriate QC systems. Preferably in a scalable and modular manner, so that the facilities can grow and develop as the individual company develops.
About Chemelot Campus
Chemelot Campus is an Open Innovation Campus in Sittard-Geleen, The Netherlands. Chemelot Campus offers a vibrant community of innovative world leading companies and knowledge institutes, state of the art high tech R&D and manufacturing infrastructures, Venture Capital and Business Development services to the companies on the campus and companies that establish a subsidiary. Over fifty companies currently present at Chemelot Campus are focused on Research & Development in the fields of Performance Materials, Bio-based Materials and Biomedical Materials. Biomedical Materials comprise Regenerative Medicine, Tissue Engineering, Drug Delivery Systems, Medical Coatings and Implants. With its location at the axis of the cross-border region Netherlands-Belgium-Germany and the offices of the European Parliament, the campus is a European stepping stone for global expansion. This unique position attracts innovative companies, unique knowledge institutes and visionary investors. Chemelot Campus is a junction where entrepreneurs and companies accelerate each other’s growth and students create and find their new jobs.
Pharmacell is a GMP certified company, headquartered in Maastricht (NL). Being a global leader as CMO in Regenerative Medicine the company recruits clients worldwide in the field of cell therapy and Regenerative Medicine and performs the manufacturing of these companies for the European market.
About Chemelot InSciTe
The Chemelot Institute for Science and Technology, Chemelot InSciTe is a unique Public-Private Collaboration of the Eindhoven University of Technology, Maastricht University/Medical Center, DSM and Chemelot Campus. One of the goals of Chemelot InSciTe is to develop smarter biomedical materials to be able to sustain the ever more expensive health care. Chemelot InSciTe combines the forces, knowledge and expertise of talented scientists, pioneering R&D focused companies and innovative laboratories active in the field of Biomedical Materials. The founding fathers have jointly invested €40M for the coming 6 years, the total budget will be €80 million, thereby stimulating both employment and the further development of knowledge and activity in the Limburg region and beyond. For biomedical applications, the institute will be working on, among other things, materials for new blood vessels, materials by means of which cartilage can repair itself and regenerate in the body, and clever miniature ‘containers’ of medicines that are placed in the eye to prevent and treat eye infections.
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For more information:
Chemelot Campus B.V.
+31 6 19271669