Specialist Support for the Bone Substitute Industry

Background

The bone substitute industry in an industry that has been around for about 25 years in which a man made porous material is created from a material, hydroxyapatite, consisting of two elements.

The material is mixed into a paste and then surgeons paste it into the spine or skull and blood vessels are allowed to then grow through it.

Agenda1 selected because theyve been working with this industry for a number of years and so have a wide range of experience concerning the industry. Theyve dealt with a range of bone manufacturing companies.

Offer GMP and XRD work.

Upto fifty percent of bone is made up of a modified form of the inorganic mineral hydroxyapatite.

Found in teeth and bones and used as a filler to replace amputated bone or as a coating to promote bone ingrowth into prosthetic implants.

Resources

X-ray Diffraction

X-ray Fluorescent

ICP

Skilled team of scientists that understand the pharmaceutical and medicinal world.

Methods

Developed methods, agreed validation process and then carried out validation work.

Sample preparation methods also had to be developed.

XRF

XRD

ICP

Results

Single certificate of analysis provided which matches the client specification. Quality control procedure in place to investigate any results that are out of the specification bounds.