Fina Biosolutions announces that the United States Patent and Trademark Office has issued a patent for expression and purification of the conjugate vaccine protein CRM197 in E. coli. CRM197 is a key component of many vaccine formulations utilized worldwide.
"Our goal is to reduce the vaccine cost barrier and grant people in need access to life-saving vaccines," said Dr. Andrew Lees, Founder and CEO of Fina Biosolutions. "We couldn't be more pleased to announce that we succeeded in creating a needed vaccine protein, CRM197, in an efficient and more cost-effective way. Our proprietary method of production will help people around the world protect themselves, their children and their loved ones from pneumonia, meningitis and more."
Prior to Fina Biosolutions' new method of production, the CRM197 protein was manufactured by Corynebacterium diphtheriae at low yields or was available commercially at high cost. Limited access to the protein hindered vaccine development and increased vaccine production costs considerably, especially for emerging market manufacturers. The recently-granted patent is for Fina Biosolutions' revolutionary new method of CRM197 expression, which produces the protein at very high yields without the need for Corynebacterium diphtheriae. The CRM197 manufactured by this method is soluble, properly-folded and expressed in the cytoplasm of E. coli, a bacterium commonly used in biotechnology.
With this invention, low-cost production of a valuable vaccine component is now possible and opens the door to manufacturing conjugate vaccines at lower costs. Corresponding applications have been filed and are issued or pending in many other countries. The issuance of the United States patent 10,093,704 closely follows the allowances of corresponding applications in Australia, New Zealand and South Africa. Fina Biosolutions markets CRM197 under the tradename EcoCRM®, for E. coli CRM197. The protein has been evaluated extensively in preclinical studies, including vaccines for infectious diseases, cancer, addiction treatment and Alzheimer's. EcoCRM® is available for licensing.