bioMD signs lab facilities deal with RPH

Perth-based medical device company bioMD Ltd subsidiary Celxcel Pty Ltd has signed a deal with Royal Perth Hospital's Cell & Tissue Therapies WA division of Laboratory Medicine, to provide its biotherapeutic manufacturing facility services to the company.

Celxcel will utilise the facilities to manufacture all the bioimplant tissue patches required for human trials, biocompatibility testing and ongoing small volume clinical requirements.

The full text of a company announcement is pasted below

bioMD Limited is pleased to announce that its subsidiary, Celxcel Pty Ltd, has signed a Services Agreement for the provision of Biotherapeutic Manufacturing Facility Services with "Cell & Tissue Therapies WA" (CTTWA), Division of Laboratory Medicine, Royal Perth Hospital.

Celxcel will utilise the facility to manufacture all the product required for human trials, biocompatibility testing and ongoing small volume clinical requirements.

CTTWA is a newly established manufacturing unit at Royal Perth Hospital. The unit was developed to meet the demands of current and emerging biotherapies and the increased regulatory requirements of manufacturing in the area of tissue and cell-based therapies.

CTTWA not only provides cell and tissue therapies for WA patients but also has a mandate to promote research and development of emerging cell and tissue therapies.

Dr Richard Herrmann, the Director of CTTWA, said, "The facility is a multi-disciplinary facility that was set up to serve many clinical specialties across WA and support approved public and commercial therapeutic manufacturing. Our first major commercial service agreement with bioMD and Celxcel indicates the value to the WA biotechnology sector of such a facility. The synergies between our facility's knowledge and strengths and Celxcel's tissue processing technology will be further explored."

Mr Michael Bennett, Managing Director of bioMD and Celxcel, said, "We are extremely pleased to have secured a services agreement with a tissue manufacturing unit that has excellent infrastructure and comes with both GMP and Therapeutic Goods Administration (TGA) licensing already in place."

"The manufacturing of our bioimplant tissue patches for both our upcoming human clinical trial and international, independent biocompatibility testing will now proceed within a modern and regulatory-approved facility. It also gives us the ability to produce small batch runs for ongoing clinical evaluation and to provide product for incorporation into new and emerging medical devices. We also look forward to a co-operation with CTTWA in further product development."

Celxcel will commence utilising the facility immediately with the incorporation of our operating procedures into the overall QA Program of CTTWA.