BENZONASE(R) SUITABLE FOR BIOPHARMACEUTICAL PRODUCTION EMPROVE(R) BIO (C15-1291-407)

General description

Benzonase^® endonuclease acts as an unspecific endonuclease, degrading both DNA and RNA to small 3–5 base pairs (< 6 kDa) fragments with no base preference. It is the ideal tool for nucleic acid removal in virus vector and vaccine manufacturing as demanded by regulators. Additionally, the use of Benzonase^® endonuclease increases the yield in virus purification, protects downstream chromatography and filter devices from fouling, and reduces feed stream viscosity.

Benzonase^® endonuclease is the smart solution for DNA removal in viral vaccine and viral vector production and has proven its value for over 30 years. Balancing efficiency and regulatory compliance by delivering reliability and high-quality due manufacturing under good manufacturing practices (GMP ICH Q7). Our extensive documentation packages of Emprove^® dossiers and the availability of a FDA Drug Master File type II, supports you in filing your vaccine manufacturing process to the authorities.

Our SAFC^® portfolio of high-quality products for biopharmaceutical processing withstands strict quality control procedures and is produced according to MQ-500 requirements as defined by the M-Clarity program.

M-Clarity Program

As part of our EMPROVE^® Program, our raw materials are offered with EMPROVE^® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.

Our comprehensive portfolio of downstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Ranging from non-GMP grades for low-risk application, to IPEC-PQG GMP for higher-risk applications, we have products covering all your manufacturing needs.

Application

Used for the removal of nucleic acid from protein samples.

Biochem/physiol Actions

Digests native or heat-denatured DNA and RNA.

Analysis Note

Appearance (description): clear
Appearance (color): colourless
Activity (DNA; pH 8.0; 30 min; 37 °C): ≥ 250 U/µl
Spec. activity (calc. on protein): ≥ 1.1E+06 U/mg
Identity (electrophoresis): passes test
Purity (calc. on protein): ≥ 99.0%
Proteases: not detectable
Colony count (aerobic bacteria): <10 CFU in 100 000 U
Colony count (Yeasts and moulds): <10 CFU in 100 000 U
Endotoxines (LAL-test): <0.25 EU in 1000 U

Legal Information

Benzonase is a registered trademark of Merck KGaA, Darmstadt, Germany

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany