2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
News|Articles|May 1, 2004
- Pharmaceutical Technology-05-01-2004
- Volume 2004 Supplement
- Issue 3
Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative
Author(s)James P. Agalloco
FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.
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Articles in this issue
over 22 years ago
Implementing Total Organic Carbon Analysis for Cleaning Validationover 22 years ago
The Future of Aseptic Processing?An Updateover 22 years ago
Analysis of Environmental Microbiology Data from Cleanroom SamplesAdvertisement
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Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
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Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
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