Getting to Market with High Quality, Consistency, Scalability, and Compliance

A non-toxic mutant of diphtheria toxin, our commercially proven PeliCRM197® carrier protein enhances the immunogenicity of antigens used in conjugate vaccines. Conjugate vaccines have been highly effective in preventing bacterial infections and have played a significant role in reducing the burden of diseases like pneumonia, meningitis, and Hib infections, particularly in children.

Currently, our PeliCRM197® customers are investigating a wide variety of other applications for this promising carrier protein in immunotherapies, neurodegenerative disease drugs, and anti-addiction vaccines. PeliCRM197® is produced in the Pfenex Expression Technology® and has an extensive safety record, with five approved and marketed products utilizing the Pfenex technology.

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 CGMP availability since 2011.

approved and marketed

Pneumococcal vaccines using PeliCRM197® produced by our Pfenex Expression Technology® have been approved by the FDA, European Medicines Agency (EMEA), and World Health Organization (WHO) for their respective territories. Pfenex produced CRM197 is used in Merck’s VAXNEUVANCE™, and Serum Institute of India Private Limited’s (SIIPL) Pneumosil® and MenFive®. 

CRM197 is a non-toxic mutant of diphtheria toxin having a single amino acid substitution of glycine to glutamic acid at position 52. It is a well-defined protein and functions as a carrier for polysaccharides and happens, making them immunogenic.

CRM197 is used as a carrier protein in a number of approved conjugate vaccines for diseases caused by S. pneumoniae, H. influenzae b and N. meningitidis. Additional research and development areas include immunotherapies and anti-addiction vaccines.

PeliCRM197® is a recombinant, soluble CRM197 produced in Pseudomonas fluorescens using the Pfenex Expression Technology® platform. Our industry-proven PeliCRM197® has the same amino acid sequence, structure and function as protein produced in C. diphtheriae, as shown in physicochemical and in vivo studies. 

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

Species
Corynebacterium diphtheriae

Storage
Store at 2-8 °C upon receipt

Purity
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. Reconstituted PeliCRM197® should be stored at 2-8 °C.

$2,000.00

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.

Source
Pseudomonas fluorescens

Species
Corynebacterium diphtheriae

Storage
Store at 2-8 °C upon receipt

Purity
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. Reconstituted PeliCRM197® should be stored at 2-8 °C.

$250.00