Biotechnology
Tepha’s proprietary technology utilizes genetic engineering to produce its designer PHA biomaterials, TephaFLEX material and TephELAST material, which can be converted into a wide range of products that restore, repair, or improve tissue function. The fundamental technology is based upon novel methods for producing a class of these natural PHA materials. In fact, these polymers are synthesized in nature by numerous microorganisms, and they have been recognized as the fifth class of naturally occurring biopolymers (along with the polyamino acids, polynucleic acids, polysaccharides, and polyisoprenoids).1 Unlike the other naturally occurring biological polymers, however, the PHA polymers are thermoplastic, i.e. they can be repeatedly softened with heat and hardened with cooling. As such, these polymers can be processed much like many of the plastics we use today.
Tepha’s biomaterials are produced by proprietary transgenic fermentation processes, similar in some respects to those used to produce biopharmaceuticals, but with substantially higher yields of product. The company is able to control the composition of the biomaterial through the appropriate selection of genes, production vehicles, feedstocks, and pathway engineering methods.
The attributes of Tepha's PHA polymers present significant advantages in medical device applications. In vivo studies have shown that the company's biomaterials are biocompatible and less inflammatory than PGA and PLA, and they degrade by cell-friendly processes into metabolites that already exist in humans while some of the competing biomaterials, in contrast, release highly inflammatory acids that can impair this process. Typically, degradation rates of Tepha’s PHA biomaterials can range from a few weeks to approximately one year. This range allows the Company to develop its biomaterials for products requiring prolonged strength retention, such as sutures for use in orthopedic procedures or materials for ligament repair.
Until recently, the widespread use of this class of biomaterials had been limited by the lack of commercially viable production technology. However, in the 1980's researchers at the Massachusetts Institute of Technology made a major breakthrough in the development of new biological production systems, when they successfully isolated the genes responsible for making these polymers in microorganisms. Tepha’s sister company, Metabolix, Inc. (NASDAQ: MBLX) first took up the challenge of using this discovery to develop transgenic systems for the commercial production of such polymers, and the firm successfully developed several transgenic fermentation methods for producing different polymers. This allowed the development of production technology that could be used to produce these biomaterials in commercial scale, and Tepha has further developed the production process and the medical applications for these PHA polymers.