Developments

Bone substitutes with novel controlled drug release technology

One of our customers has designed a novel drug release technology, which allows a controlled antibiotic release over a defined period of time. The designed product is a combination of a polymer with a lipid-based reservoir system. This specific product is designed for bone void filling and is used as an advanced bone substitute due to the long-lasting antibiotic release. EMCM has aligned the manufacturing process into a fully classified GMP process. Ongoing activities include the scale-up of the manufacturing with respect to the critical manufacturing parameters as well as the quality guidelines.


Development, upscale and tech-transfer of recombinant products

EMCM is working on a technology transfer project for another global company. A recombinant protein has been designed by the customer which will be applied in the dental field. The product has been developed on a R&D scale and includes multiple critical steps during its manufacturing such as freeze-drying, crosslinking reactions and sterilisation. Therefore, EMCM has aligned the manufacturing of the product in an early-stage in order to maintain all product properties. The production process will be translated in an upscaled process as well validation into our qualified cleanrooms and handling procedures.

Safe, clean and innovative human tissue products

EMCM is continually involved in the manufacturing and servicing of tissue banks with the supply of bone allograft tissues, using elements of its proprietary eCOO® Technology know-how. This includes the manufacturing of bone tissue grafts which are processed using scCO2 and investigating product enhancements using cell lysates and bioactive compounds such as growth factors and antibiotics. The end products are rendered with superior properties in sterility, purity and with lower traces of harmful toxic residues. Compared to conventional fresh bone allografts, the scCO2 processed bone material has a significantly lower risk of transmitting donor specific proteins to the recipient minimising graft rejection and an inflammatory response. The end products are thus enhanced with external triggers (drugs, bioactive peptides) and increased levels of osteointegrative features.

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