HIGH QUALITY, CONSISTENT, SCALABLE, AND COMPLIANT
CRM197, a non-toxic diphtheria toxin mutant used as a carrier protein, helps enhance antigen immunogenicity in conjugate vaccines used to prevent diseases such as pneumonia, meningitis, and Hib.
Our PeliCRM197® customers are investigating a wide variety of other applications for this promising carrier protein in immunotherapies, neurodegenerative diseases, and anti-addiction vaccines.
PeliCRM197 is produced in the Pfenex Expression Technology®, which has an extensive regulatory and safety record, with five marketed products utilizing the Pfenex platform.
the only CRM197 you can buy that’s used in marketed vaccines
Primrose Bio’s PeliCRM197® is offered in various grades and sizes and provides a reliable, high-quality supply of this essential vaccine component for developers. CRM197 produced with Pfenex Expression Technology® is found in VAXNEUVANCE®, Pneumosil®, and MenFive®.
Vaxneuvance® is a registered trademark of Merck, Inc. Pneumosil® and MenFive® are registered trademarks of Serum Institute of India Pvt. Ltd.
Scalability
Guaranteed supply of research and CGMP grade PeliCRM197 from milligrams to kilograms throughout development and commercialization. Seamless transition from research to commercial production.
Support
Supported by a Drug Master File (DMF) filed with the US FDA to simplify your regulatory submissions. A comprehensive Regulatory Support Package is available for customers outside the USA.
Quality
Highest purity CRM197 commercially available (Hickey JM, et al., JPS 2018).
Compliance
The only commercially sold recombinant CRM197 used in marketed vaccines, with GMP certification since 2011.
Regulatory Support
A Drug Master File (DMF) for PeliCRM197® is maintained with the US FDA to simplify your regulatory filings. Upon request, we provide a Letter of Authorization (LOA) to permit reference to the PeliCRM197® DMF in your applications. This saves you time and effort by not needing to describe PeliCRM197 as a starting material in your submissions and enables the FDA to reference the DMF in their review of your dossier. For submissions outside the US FDA, we provide a Regulatory Support Package containing the technical information needed for inclusion in your drug application. Please contact us to request your necessary documents.
References
The amino-acid sequence of two non-toxic mutants of diphtheria toxin: CRM45 and CRM197
Giannini, G., et al. Nucleic Acids Research, May 25, 1984.
Analytical Comparability Assessments of 5 Recombinant CRM197 Proteins from Different Manufacturers and Expression Systems
Hickey, J.M., et al., Journal of Pharmaceutical Sciences, July 2018.