28 September 2018 - - The United States Patent and Trademark Office has issued a patent for expression and purification of the conjugate vaccine protein CRM197 in E. coli, US-based biotechnology company Fina Biosolutions said.

CRM197 is a key component of many vaccine formulations utilized worldwide.

Prior to Fina Biosolutions' new method of production, the CRM197protein was manufactured by Corynebacterium diphtheriae at low yields or was available commercially at high cost. Ltd. 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.

Many vaccine components do not induce an immune response unless linked (conjugated) to a protein, such as CRM197. CRM197 is a widely used component of conjugate vaccines, including the world's best-selling vaccine, Prevnar13 (Pfizer's pneumococcal vaccine).

CRM197 is also a component of vaccines for Haemophilus influenzae b, meningococcal and many vaccines in development. CRM197 is a genetically detoxified diphtheria toxin.

Fina Biosolutions is a privately-owned R and D biotechnology company located in Rockville, MD. The company provides laboratory services and technology in the field of conjugate vaccines.

Chemistry developed by Fina Biosolutions scientists is used in GlaxoSmithKline's pneumococcal conjugate vaccine, Pfizer's meningococcal conjugate vaccine and others.

Fina Biosolutions and scientists collectively hold fourteen patents in the field of conjugate vaccines, with several currently used in some of the most important vaccines on the market.