About Bionext
Bionext® is an enterprise dedicated to develop and provide biotechnology solutions which create value to our customers.
Rapid progress has been made in recent years in the field of biomedical materials, which utilize both natural and synthetic polymers and which can be used in a variety of applications, including wound closure, drug delivery systems, novel vascular grafts, or scaffolds for in vitro or in vivo tissue engineering.
Several microbial derived polysaccharides have interesting physical and biological properties and are particularly useful in various biomedical applications. Microbial Cellulose (MC), a polysaccharide synthesized in abundance by Acetobacter xylinum, has already been used quite successfully in wound-healing applications, proving that it could become a high-value product in the field of biotechnology.
Bionext® has effective control of the technological process and has applications for patents filed both in Brazil and abroad. The company is already producing in large scale from selected strains. Moreover, it has developed its own equipment necessary for the manufacturing and final processing of the end products.
Bionext® has its own labs for Quality Control and Research & Development.
In order to certify Bionext® main products in the major international markets, the factory was designed to operate in compliance with the Good Manufacturing Practices – GMP requirements whose criteria are required for approval by the Food and Drug Administration – FDA, the federal agency in the United States responsible for ensuring that foods and drugs are safe and effective.
Procedures also abide by the requirements set forth by ANVISA in Brazil – (Brazilian National Health Surveillance Agency) and by similar regulatory agencies for pharmaceutical products in the European Community.