Berkeley Advanced Biomaterials

Company Background

Berkeley Advanced Biomaterials (BAB) manufactures high-quality, cost-effective skeletal repair resorbable biomaterials. The company offers the entire range of biologics from synthetics to allografts. Berkeley Advanced Biomaterials is a licensed Tissue Bank that has been accredited by AATB. The Ostetic products (Bi-Ostetic™ and Cem-Ostetic®), are based on hydroxyapatite (HAP) technology. These products are available in granule, block and injectable putty formulations. Ostetic products have been in use both overseas and in the U.S. since 2003 (1a).

Berkeley Advanced Biomaterials was incorporated in the state of California in October 1996. BAB specializes in producing hydroxyapatite (HAP) and calcium-based materials. The company has developed several implantable bioresorbable medical devices used in orthopaedic and spine surgery in the USA and Europe (2).

Suppliers & Buyers

Orthofix International has entered into an agreement with BAB wherein Orthofix will market and distribute an FDA-cleared line of bone repair resorbable biomaterials engineered by BAB for trauma and reconstruction applications.  Under the agreement, Orthofix will market and sell this line of BAB resorbable biomaterials that will be packaged for Orthofix as granules, blocks, moldable putty and putty-injection kits. This line of osteoconductive bone scaffold biomaterials based on nanocrystalline hydroxyapatite technology is engineered to resorb quickly, thereby allowing bone to remodel rapidly (3). 

Strategic Partnerships

Berkeley Advanced Biomaterials has collaborated with many universities for studies and experiments including the Department of Pharmaceutical and Administrative Sciences at Creighton University (4).

Innovation and Technology

During the last two decades, significant progress has been made in the area of drug delivery systems. Drug delivery in the future will require sophisticated devices that are controlled, self-regulated, and can release drugs only at target sites. With the recent developments in micro-encapsulation technology, HAP micro-spheres are being considered for drug delivery applications. HAP has the advantage of being bio-compatible, bio-resorbable and highly binding to a variety of molecules (e.g. proteins, enzymes, antibody fragments, nucleic acids, and some sub-classes of IgG). This has opened the potential for using HAP to deliver a large variety of drugs in many clinical applications (4).

A study of HAP implants for the treatment of bone infections was recently performed in collaboration with Professor A. K. Dash from the Department of Pharmaceutical and Administrative Sciences at Creighton University. HAP micro-spheres containing ciprofloxacin were prepared by precipitation followed by a spray drying process. The drug load in the micro-spheres ranged from 0.25-2% (w/w). SEM, powder X-ray diffraction, and Differential Scanning Calorimetry showed that the surface morphology of the micro-spheres was rough and that the drug was present at a molecularly dispersed state in the HAP. Implants (5x8 mm) were made by pressing the powder into small cylinders. The mechanism of in vitro drug release from the implant was found to be controlled by diffusion in the matrix. For this set of experiments, complete release of the drug occurred within 10 hours. The release rate can be increased by increasing the concentration of the drug and decreased by introducing diffusion barriers in the implants (4).

Bone is a complex structure with macro- and micro-pores. The pores are mostly interconnected to allow body fluid to carry nutrients and provide a medium where interfacial reactions between hard tissue and soft tissue can occur. Two types of bone structures have been described: cancellous and cortical structures. Cancellous bone differs from cortical bone in being open-spaced and trabecular. Since osteons average between 180 and 250 µm in diameter and intercommunicate through Volksmann canals, the size of the interconnected pores have similar dimensions. Berkeley Advanced Biomaterials’  research is focusing in developing high strength synthetic biomaterials such as CPA and HAP ceramics. The ceramics are either sintered porous or dense calcium-based mixtures (including HAP and TCP). Our research team recently completed an extensive characterization of the sintering behavior of their narrow size distribution powder. BAB also has completed a study of the phase transformations that can occur in their sintered micro-porous HAP. Their research team is now designing high strength three-dimensional cellular biomaterials (4).

Products

  • Cem-Ostetic®
  • Bi-Ostetic™
  • GenerOs™
  • DBM putty, gel, crunch, and strips (1b).

Sources

  1. Ostetic (2010). Retrieved on October 1, 2013
    1. “Overview” from www.ostetic.com/index.html
    2. “Products” from www.ostetic.com/products.html  
  2. AZoNano (2013). “Berkeley Advanced Biomaterials Inc.” Retrieved on October 1, 2013 from www.azonano.com/suppliers.aspx?SupplierID=623
  3. Business Wire (2005, April 26). “Orthofix in Agreement with Berkeley Advanced Biomaterials to Market and Distribute Bone Repair Resorbable Biomaterials for Trauma and Reconstruction Applications.” Retrieved on October 1, 2013
  4. Berkeley Advanced Biomaterials Inc. (2013).  “Current Research and Applications.” Retrieved on October 1, 2013 from www.hydroxyapatite.com/research.html