PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
|Articles|July 2, 2014
- Pharmaceutical Technology-07-02-2014
- Volume 38
- Issue 7
Laboratory Filter-Dryer Enables Scalability
Author(s)Melanie Sena
Laboratory Filter-Dryer Enables Scalability
The GFD laboratory nutsche filter–dryer from Powder Systems Limited, originally developed in glass, is available in metal to allow higher pressures. The laboratory- scale unit can be used for feasibility studies and trials before scaling up to a commercial-scale agitated nutsche filter dryer (ANFD). The stainless-steel 316 L or alloy C22 versions allow better replication of the pressures in commercial ANFD. The Mini Lab GFD unit has a total volume of 0.3 L that can filter a cake volume up to 0.1 L and is suitable for laboratory-scale trials. The Lab GFD size includes a removable filtration basket of 0.01-m² for a cake volume of 0.5 L for small-scale synthesis. The Maxi Lab GFD filters a cake volume of 5 L with 0.05-m² filtration area.
Articles in this issue
about 12 years ago
Trends in Manufacturing and Equipmentabout 12 years ago
The Mainstreaming of Continuous Flow API Synthesisabout 12 years ago
Health Systems Raise the Bar on Reimbursing New Drugsabout 12 years ago
Data Integrityabout 12 years ago
Environmental Monitoring System Improves Efficiencyabout 12 years ago
Automating Online Sampling of Bioprocessesabout 12 years ago
Sieve Shakers Ensure Reliabilityabout 12 years ago
Sterilization of Blow-Fill-Seal Equipment for Aseptic FillingRelated to this article
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
Karthik Iyer, Eli Lilly, details an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.
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