Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
News|Articles|September 2, 2004
- Pharmaceutical Technology-09-02-2004
- Volume 28
- Issue 9
Design of an Aseptic Process Simulation
Author(s)Francis Roganti, Richard J. Boeh
The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.
Advertisement
Articles in this issue
about 22 years ago
In the Spotlight-September 2004about 22 years ago
Promoting Quality in Drug Manufacturingabout 22 years ago
Automation in a Digital, Webbed, and Wireless Ageabout 22 years ago
September 2004about 22 years ago
Early Development Still Driving CRO Performanceabout 22 years ago
Particulate-Free PalletsAdvertisement
Related to this article
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.
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.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Advertisement
Advertisement