PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
|Articles|May 2, 2019
- Pharmaceutical Technology-05-02-2019
- Volume 43
- Issue 5
New Kit Identifies Endonuclease Impurities
The EndonucleaseGTP ELISA Kit from Cygnus Technologies detects and quantitates residual endonuclease impurities in recombinant vaccines and viral vectors used for gene therapy.
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
Closed Systems for Aseptic Fill and Finishover 7 years ago
Contract Packaging Growsover 7 years ago
New Pneumatic Pressesover 7 years ago
New Size for AODD Pumpover 7 years ago
1000-Gallon Pivoting Triple Shaft Mixerover 7 years ago
Bioprocessing Facilities and FDA Inspection Problemsover 7 years ago
FDA Faces Challenges After Gottliebover 7 years ago
The Auditor Vs. Inspector Issueover 7 years ago
Avoiding Excipient Variabilityover 7 years ago
Working for the Greater GoodRelated to this article
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
Karthik Iyer, Eli Lilly, details an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.
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