This year’s AAPS PharmSci 360 highlighted AI transparency, computer modeling in formulation, oral peptide delivery, and new business models.
|Articles|March 15, 2002
- BioPharm International-03-15-2002
- Volume 15
- Issue 3
Business Benefits of Computer Systems Validation
Author(s)Mary Jo Veverka
by Mary Jo Veverka Accenture Significant amounts of time and effort are spent on validating computer systems. Companies that want efficient, high-quality systems can avoid considerable consts by incorporating CSV capabilities throughout systems development.
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Articles in this issue
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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
A System Developer's Approach to ValidationAdvertisement
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FDA approves Sun Pharma’s Ilumya for active psoriatic arthritis, BioMarin licenses a subcutaneous Fabry enzyme replacement therapy from GC Biopharma and Hanmi, and Lonza expands bioconjugation capacity in Visp to meet rising ADC demand.
In the second part of an interview for BioPharm International’s AAPS PharmSci 360 2026 coverage, Nanoform’s Chris Worrall shares 18-month stability data for a 414 mg/mL trastuzumab suspension and explains how ultra-high-concentration formulations could shorten administration and support at-home injection.
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Lonza's Visp expansion adds 3 multiproduct suites at up to 1200 L plus 500-L single-use capacity to scale commercial ADC production from 2028.
The first-in-class molecule, licensed to Dianthus as DNTH212 outside Greater China, is designed to block type 1 interferon production and BAFF/APRIL-driven B-cell activity with a single drug.
HM15421/GC1134A could become the first subcutaneous enzyme replacement therapy for Fabry disease, with BioMarin paying $70 million upfront.
The IL-23p19 inhibitor tildrakizumab becomes the third drug in its class approved for psoriatic arthritis, and the only one given exclusively by a healthcare provider.
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