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|November 15, 2002
- BioPharm International-11-01-2002
- Volume 15
- Issue 11
Employing Near-Infrared Spectroscopic Methods of Analysis for Fermentation Monitoring and Control: Part 1, Method Development
by S. Alison Arnold, Linda M. Harvey, and Brian McNeil from the Strathclyde Fermentation Center, Strathclyde, Scotland; and Jeffrey W. Hall, Foss NIRSystems Although rarely available, timely process information about fermentation biomass, substrates, intermediates, and nutrients is required to make control decisions. NIR spectroscopy offers the opportunity to improve fermentation processes by incorporating rapid, nondestructive, multiconstituent analyses of fermentation broth media directly into fermentation monitoring and control strategies.
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Inside Washington: Major Changes Ahead for FDAalmost 24 years ago
Bioinformatics Databases ? Questions of Copyrightalmost 24 years ago
European Editor's Report ? An Industry Comes of Agealmost 24 years ago
Guest Editorial: Back to the Beginningalmost 24 years ago
You Have Failed . . . A Case Study in Warning Letter Remediationalmost 24 years ago
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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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