great post and a little salt added
Vivos owned patented technology which makes the production of Y-90 particle more cost-effective, lesser time and much tinier, all these make PNNL(Battelle) having no choice to continue licensing the original patents to Vivos. This is good and great because of Vivos leading the way to commercialize it in more effective ways.
RICHLAND, WA / ACCESSWIRE / July 11, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a late stage radiation oncology focused medical device company today announced that a new proprietary process has been developed that significantly improves originally licensed technology on the company's Y-90 RadioGel™ device.
After five months of effort, the AMI team have finalized an improved manufacturing process for our yttrium phosphate particles. We conducted more than thirty process development runs to achieve the most cost-effective process to reproducibly give us the small particles that we desire.
Small particles perfuse further into the tumor and reduce the number of injections required for dose coverage in large tumors. In parallel, we concentrated on reducing the time and cost required for manufacturing and increasing the batch yield. As an example, one production step was reduced from 20 hours to just an hour. Product yield increased from 80% to 99.99%. The process is elegantly simple, but based on fundamental understanding of the underlying chemistry involved.
IsoTherapeutics, a key manufacturing and testing contractor, did a very professional job working with our team to explore all of the key manufacturing variables.
AMI Interim CEO and President Dr. Mike Korenko stated, "This is a significant improvement over the technology that was originally licensed to AMI from the Pacific Northwest National Laboratory. This new proprietary process is an important part of our intellectual property and will reduce our manufacturing costs to position AMI to make a profit on future sales.
The manufacturing process has now been institutionalized in a formal Standard Operating Procedure, which is needed to ensure a safe reproducible product for animal and human therapy and it is the protocol required by the Food and Drug Administration."
Dr. Korenko added, "This accomplishment required a great deal of effort and is a major step in executing our business plan, which I outlined in my first letter to Shareholders January 2017."
AMI previously created the Standard Operating Procedures for the hydrogel (RadioGel™). We are now working on the Quality Assurance and Quality Control Plans and to convert all process activities to GMP (Good Manufacturing Processes) which is a FDA requirement. This will complete the entire disciplined manufacturing process requirements.
