The Skyrizi approval pairs an interleukin-23 antibody with an on-body injector for 720 mg subcutaneous induction in adults, per phase 3 AFFIRM data.
|Articles|March 15, 2002
- BioPharm International-03-15-2002
- Volume 15
- Issue 3
Validation of Quantitative PCR Assays?Addressing Virus Contamination Concerns
by Archie Lovatt, Donna McMutrie, John Black, and Iain Doherty Q-One Biotech Ltd. Real-time quantitative PCR has revolutionized the detection and quantification of viral contaminants. Quantitative PCR assays can detect noncytopathic viruses that have recently become a concern in testing for biopharmaceutical safety. High versatility reproducibility, and throughput of such assays decrease the time spent in development, testing, and regulatory compliance.
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Articles in this issue
over 24 years ago
Inside Washington: Biotech Manufacturing ? Obstacle or Opportunity?over 24 years ago
Guest Editorial: Warning Letters ? A Symptom?over 24 years ago
The Importance of Freezing on Lyophilization Cycle Developmentover 24 years ago
Business Benefits of Computer Systems Validationover 24 years ago
A System Developer's Approach to ValidationAdvertisement
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Gilead agrees to acquire PepStar’s oral IL-23R peptide program for $1.275 billion, Zymeworks licenses its DLL3-targeted trispecific T-cell engager ZW209 to Roche, and the US Treasury proposes adding biotechnology to its outbound investment restrictions.
FNIH CEO Dr Julie Gerberding will open the October 25-28 meeting with a talk on using AI, adaptive trials, and alternative methods in drug development.
Insilica's Dr Thomas Luechtefeld argues process traceability, not benchmark accuracy alone, determines whether AI toxicology decisions can be trusted.
Phase 1 HCXT-2001, an oral macrocyclic IL-23R peptide, could be paired with emvistegrast as a daily oral IBD treatment, according to Gilead.
Roche gains exclusive global rights to ZW209, a DLL3×CD3×CD28 trispecific T-cell engager designed for CD28 co-stimulation. A phase 1 study in small cell lung cancer and other neuroendocrine tumors is underway.
A Treasury proposed rule would restrict certain US investments in biotechnology in China and other countries of concern, raising questions about how cross-border licensing and joint venture deals will be treated.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
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