Manufacturing Authorisation and European Approval to Produce Allogeneic Bone Cell Therapy Products.
BONE THERAPEUTICS, he leading international biopharmaceutical company focused on innovative cell therapy products for the treatment of bone diseases, announces that it has been awarded both ‘Tissue Establishment and ‘GMP’ Accreditation for the manufacturing of its ALLOB® allogeneic bone cell therapy product, being initially developed for the treatment of impaired fractures.
The Tissue Establishment (i.e., Intermediate Structure) Accreditation is a pre-requisite for the manufacture of allogeneic cell therapies, and will permit Bone Therapeutics to have enhanced control over the ALLOB® production line. Bone Therapeutics’ Intermediate Structure will be able to process, preserve, store and distribute human tissues upon their release from LTCG, the Tissue Bank. Bone Therapeutics will work in collaboration with the LTCG, the accredited Tissue Bank from the CHU Sart-Tilman based in Liège, Belgium and headed up by Prof. Yves Beguin.
This approval further strengthens Bone Therapeutics’ cell product manufacturing capabilities. In addition to the allogeneic platform, Bone Therapeutics has autologous ‘Production Establishment Accreditation’ and manufacturing authorisations, which enables the Company to work on PREOB®, its autologous bone cell product, and manage all product design, engineering, validation, production and quality assurance to the highest GMP standards.
Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics, commented: “Being awarded with ALLOB® manufacturing authorization is great news for Bone Therapeutics. This recent accreditation follows an earlier Manufacturing Authorization for our lead product, PREOB® and we are delighted that we have the necessary approvals to enable the onward development of both products.“