FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|May 1, 2004
- Pharmaceutical Technology-05-01-2004
- Volume 2004 Supplement
- Issue 3
Implementing Total Organic Carbon Analysis for Cleaning Validation
Author(s)Brian Wallace
Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.
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The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ingredient suppliers, the use of AI in quality control, and more.
Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
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