This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
|Articles|May 1, 2019
- Pharmaceutical Technology\'s In the Lab eNewsletter-05-01-2019
- Volume 14
- Issue 5
Kit Identifies Endonuclease Impurities for Gene Therapy
Cygnus Technologies has developed the EndonucleaseGTP ELISA Kit to quantitate and detect residual endonuclease impurities in recombinant vaccines and viral vectors used for gene therapy.
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The EndonucleaseGTP ELISA Kit from Cygnus Technologies detects and quantitates residual endonuclease impurities in recombinant vaccines and viral vectors used for gene therapy. With a detection limit of ~0.06 ng/mL, the kit is three times more sensitive than the only other commercially available assay for detection and quantitation of these endonuclease impurities, according to the company. The kit also contains all the necessary, ready-to-use reagents for 96 analyses in microplate format, including a set of calibrated endonuclease standards. The assay can be easily integrated into desired workflow points-from process development to quality control to lot release testing.
Articles in this issue
over 7 years ago
The Importance of Particle Characterizationover 7 years ago
New Sensors for Measuring and Monitoring Cell Growthover 7 years ago
Robotic Solution Simplifies and Speeds Endotoxin Detectionover 7 years ago
Improvement in CAR T-Cell Therapy Removes Severe Side Effectsover 7 years ago
QC Lab Extends Capabilities at Cambrex’s Milan Facilityover 7 years ago
FDA Issues Bispecific Antibody Development Guidanceover 7 years ago
Protagen Protein Services, BioAnalytix Merge into CROAdvertisement
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