FMC BioPolymer AS
About FMC BioPolymer AS
FMC BioPolymer AS is one of the leading manufacturers of biopolymers for pharmaceutical and biomedical applications. The Company manufactures ultrapure alginate as well as ultrapure chitosan and hyaluronan in NovaMatrix. NovaMatrix is not a separate legal entity but a business unit of FMC BioPolymer AS. Key focus areas for NovaMatrix are: regenerative medicine, drug delivery systems, and advanced wound care applications. FMC BioPolymer AS/NovaMatrix provides biomaterials for both research as well as commercial applications on a global scale.
Relevant experience in relation to the project
FMC BioPolymer has research and production facilities where ultrapurification of alginate and chitosan takes place (low endotoxin) in a monitored clean room. Equipment required for characterization of biopolymers include a 400 MHz Varian NMR, three Waters size exclusion chromatographs (SEC) with in-line refractive index detection and coupled to Wyatt DAWN HELEOS multi-angle laser light scatter detectors (for determining molecular mass and polydispersity). The laboratory is equipped with two oscillatory rheometers (Physica, Bohlin) for determining the rheological properties of gels (visco-elastic storage moduli, gel strength) and a texture analyzer (Stable MicroSystems) for compression force measurements. Additionally, FMC BioPolymer has a tissue culture laboratory for culturing cells under sterile conditions and equipped with a fluorescence confocal microscope and a flow cytometer, and a separate microbiological laboratory. In addition, there is a separate laboratory equipped with a specialized hypoxia work station for cell experimentation at controlled, reduced oxygen concentration. FMC BioPolymer/NovaMatrix is accredited ISO 9001, ISO 13485 and ISO 22442 compliant. Manufacturing and quality control of Active Pharmaceutical Ingredient (API) products is performed in accordance with ICH Q7 guideline.
Contributions to the AnastomoSEAL Project
Two technology platforms developed by FMC BioPolymer/NovaMatrix will be available to the Consortium:
- Self-gelling alginate – an all-alginate system with controllable gelation kinetics;
- Ultrapure alginate foam with controllable degradation profiles;
- Industrial process technology and risk analysis aspects;
- IPR evaluation.
The interaction of biomaterials, scaffolds and matrices with living cells is an important aspect in the development of drug delivery systems and in regenerative medicine. FMC BioPolymer has ongoing safety and toxicology studies for both products (alginate and chitosan) and formulations (gels and solid matrices). In addition, the Company has expertise in cell-based therapy using alginate formulations.
FMC BioPolymer AS Staff Members Involved in AnastomoSEAL
While there are currently about 200 employees in the whole of FMC BioPolymer AS, about 20 employees are involved in NovaMatrix, the business unit responsible for pharmaceutical and biomedical applications.
Personnel currently involved in this project are:
Michael Dornish, Ph.D. – Scientific Director with responsibilities to coordinate and progress research in biomedical uses of biopolymers for drug delivery, cell encapsulation and tissue engineering applications. He is a EUROTOX toxicologist with responsibility for safety and toxicology documentation of FMC’s ultrapure biopolymers as well as creating and maintaining international standards and guidelines for biopolymers.
Therese Andersen, Ph.D. – Senior Scientist with a PhD in alginate biomaterials and instrumental in development of scaffold IP. Main contribution to the project will be development of patch prototypes, scale-up of patch manufacturing processes and material characterization.
Pia Auk-Emblem, M.Sc. – is involved in several tasks in NovaMatrix Applications group as a Project Manager/R&D Scientist. She joined midway in the project and she participates in development of documents related to risk management and design control in addition to preparation of prototypes.
MSc Dzenana Cengic – has a background from chemical engineering and is situated in Brussels where she is a Technical Support Manager. She will be responsible for market evaluations and identification of potential partners for continuation of the project in addition to tasks related agreements and legal activities.
Former personnel involved in the project are:
Jan Egil Melvik, Ph.D. – R&D Manager with more than 20 years experience with development of alginate hydrogel systems for biomedical applications and inventor of several related patents.
Terje Svendsen – Production Manager
Christine Markussen, M.Sc. – young scientist with a background from biotechnology and polymer characterization. She was during the first year of the project responsible for preparation of prototypes and project management activities.
Relevant prior art (Patents)
US6,642,363 – Mooney, D.J., Bouhadir, K.H., Wong, W.K. and Rowley, J.A., “Polymers containing polysaccharides such as alginates or modified alginates”.
US 7,790,699 – Melvik, J.E., Dornish, M., Onsoyen, E., Berge, A.B., and Svendsen, T., “Self-gelling alginate systems and uses thereof” (also filed as WO 2006/044342).
US 2008/0033392 – Gaserod, O., Andersen, T., Melvik, J.E., Dornish, M. and Riley, P.J., “Gelled Composite” (also filed as WO 2007/103209).
US 2007/0254016 – Andersen, T., Kristiansen, A. and Joslin, S., “Biodegradable foam” (also filed as WO 2007/103208).