In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|April 15, 2003
- BioPharm International-04-01-2003
- Volume 16
- Issue 4
Virus Inactivation in the 1990s and into the 21st Century
by Gail Sofer, BioReliance Dorothy C. Lister, and Jeri Ann Boose Smallest of the microorganisms, viruses depend on other cells ? like those used by biopharmaceutical manufacturers ? for reproduction. And viruses and drug products are idiosyncratic: Both the inactivation process and the product strongly influence the successful outcome. In this conclusion to the virus inactivation series, model ivruses are used to represent single- and double-stranded DNA and RNA viruses, to enable you to reach conclusions about effective inactivation methods for a range of viruses.
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Articles in this issue
over 23 years ago
Getting Ready for Risk-Based GMPsover 23 years ago
GMP Issues: Breaking Groundover 23 years ago
Guest Editorial: Benchmarking Biotechover 23 years ago
Optimized Nutrient Additives for Fed-Batch Culturesover 23 years ago
Inside Washington: GMP Progress ReportAdvertisement
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FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
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Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Gene-corrected nula-cel freed all 3 RESTORE patients from transfusions, with sickle hemoglobin below 20% in the 2 followed for over 6 months.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
Matt Truppo, Richard Jaenisch, and Brian Drapeau examine AI's impact on drug success, human oversight, data governance, and biopharma's future.
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