Ensure product purity, consistency and GMP-compliant workflows – from process development to commercialization.
Our GMP-grade enzymes* are specifically developed for regulated biopharmaceutical applications, offering end-to-end quality control, full traceability and scalability from early development through clinical and commercial manufacturing.
Manufactured in GMP-compliant, ISO-certified facilities, our enzymes support your drug development pipeline with the performance and compliance needed for clinical and commercial success. Whether you’re developing biologics, cell and gene therapies or mRNA-based therapeutics, we provide enzyme solutions you can trust.
Start with our Molecular Biology Grade (MBG) enzymes, engineered to match the performance profile of GMP-grade counterparts to reduce revalidation efforts and accelerate your path to market. In addition to our GMP-grade enzymes, we offer flexible, on-demand enzyme manufacturing services to meet your production timelines and scale requirements.
Compliant and scalable enzyme manufacturing
Full traceability and quality systems
Key attributes of QIAGEN GMP-grade enzymes
| Attribute | Specification |
|---|---|
| Endotoxins | ≤ 0.25 EU/kU |
| Bioburden | ≤ 10 CFU per 100,000 U (aerobic bacteria, yeast, mold) |
| Purity | Validated by SDS-PAGE/HPLC |
| Activity | Functional activity is tested to ensure batch suitability |
| Animal-Origin-Free | AOF raw materials and finished products |
| Ampicillin-Free | Beta-lactam-free fermentation |
| Stability | Shelf-life verified through ongoing stability studies |
QIAGEN bioprocessing product catalogue
| Workflow | Product | Catalog number | Product description |
|---|---|---|---|
| Cell and gene therapy (viral vector purification) |
EN32-B10 EB32-B50 EN32-050 EN32-250 |
Robust salt-active endonuclease removing DNA and RNA impurities in bioprocessing workflows, highly active over a broad pH range |
|
| EN32-001 | A specialized assay designed for the quantitative detection of residual Saltonase content in intermediates, semi-finished, and finished biological products |
||
| In vitro transcription | P7180L | DNA-dependent RNA polymerase with high specificity for the T7 promoter used in IVT |
|
| Y9380L | An enzyme catalyzing the hydrolysis of pyrophosphate to inorganic phosphate (PPi), enhancing the efficiency of nucleotide synthesis |
||
| RT35-020 | Protein protecting RNA molecules from degradation by ribonucleases, ensuring the integrity and stability of RNA |
||
| RNA modification | P7460L | Addition of a polyadenylate tail to the 3' end of RNA molecules, enhancing their stability and translation efficiency |
|
| Purification |
RP102N | High-purity serine protease effectively digests all protein impurities in bioprocessing workflows |
*Disclaimer for Drug Manufacturers
“GMP-grade” is a marketing term used by QIAGEN for enzymes manufactured in compliance with established quality standards, including ISO 13485, US QSR (21 CFR 820) and ISO 9001. These enzymes are biopharma-suitable, meet stringent purity requirements and are free from animal-origin materials (AOF) used in the manufacturing processes and final product. They are produced in a dedicated lane and with AOF-compliant equipment. The “GMP-grade” enzymes do not contain beta-lactam antibiotics and have low endotoxin and bioburden levels. When incorporated into drug manufacturing processes, they are considered ‘inactive ingredients’ and are not intended to remain in the final drug product. It is the customer’s responsibility to ensure the safety and compliance of the final end-use product, including adherence to all relevant legal and regulatory requirements, as well as to verify that the enzymes perform and function as specified.