HIGH QUALITY, CONSISTENT, SCALABLE, COMPLIANT CRM197
PeliCRM197 is produced in the Pfenex Expression Technology®, which has an extensive regulatory and safety record, with six marketed products utilizing the Pfenex platform.
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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.
PeliCRM197® Lyophilized (1mg)
CRM197 is a non-toxic mutant of diphtheria toxin having a single amino acid substitution of glutamic acid for glycine. CRM197 is a well-defined protein and functions as a carrier for polysaccharides and haptens making them immunogenic.
SEE DETAILS
Description
PeliCRM197® diphtheria toxin mutant, recombinant. Research grade.
Product Background
CRM197, a non-toxic mutant of diphtheria toxin having a single amino acid substitution of glycine to glutamic acid at position 52, is a well-defined protein and functions as a carrier for polysaccharides and happens boosting immunogenicity. CRM197 is found in many marketed conjugate vaccines. PeliCRM197® has been produced using the Pfenex Expression Technology® platform since 2007 and has the most industry experience of any other commercial CRM197 available.
Production Organism
Pseudomonas fluorescens
Storage
Store at 2-8 °C upon receipt
Purity
> 95% CRM197 by RP-HPLC
Endotoxin
< 100 EU/mg of protein
Dimers and high molecular weight impurities: < 5% by SE-HPLC
Uses
Before use, aseptically reconstitute lyophilized PeliCRM197® with sterile deionized water.
$250.00
PeliCRM197® Lyophilized (20mg)
CRM197 is a non-toxic mutant of diphtheria toxin having a single amino acid substitution of glutamic acid for glycine. CRM197 is a well-defined protein and functions as a carrier for polysaccharides and haptens making them immunogenic.
SEE DETAILS
Description
PeliCRM197® diphtheria toxin mutant, recombinant.
Source
Pseudomonas fluorescens
Storage
Store at 2-8 °C upon receipt
Purity
> 95% CRM197 by RP-HPLC
Endotoxin
< 100 EU/mg of protein
Dimers and high molecular weight impurities
< 5% by SE-HPLC
Uses
Before use, aseptically reconstitute lyophilized PeliCRM197® with sterile deionized water to a concentration of 4 mg/mL CRM197.
$2,000.00
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.
Partner with Primrose Bio
For nearly 15 years, PeliCRM197 has been the industry standard where the highest quality and supply consistency for CRM197 matters the most: your products.
