Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
News|Articles|October 2, 2020
- Pharmaceutical Technology-10-02-2020
- Volume 44
- Issue 10
Automated Perfusion System
Cytiva announced that it is launching the Xcellerex Automated Perfusion System (APS), a device aimed at simplifying processes and reducing risks when intensifying upstream operations.
Cytiva announced that it is launching the Xcellerex Automated Perfusion System (APS), a device aimed at simplifying processes and reducing risks when intensifying upstream operations. Integrated with Cytiva’s Xcellerex XDR bioreactors, the APS system comes equipped with filter switching, liquid management, and cell bleed to reduce risk of human error and increase process robustness, a company press release said. The system also eliminates bottlenecks along the perfusion process, which increases productivity and output.
Articles in this issue
about 6 years ago
Unique Molecules Push Formulation Boundariesabout 6 years ago
Development of a Validated Method of Testing for NDMA in Ranitidineabout 6 years ago
Masking Taste: A Key Attribute to Successabout 6 years ago
Factoring Stability in the Biologic Drug Mixabout 6 years ago
Improving Agility Through Scalabilityabout 6 years ago
Modernizing Bioprocessing for Gene Therapy Viral Vectorsabout 6 years ago
Scaling Up Fastabout 6 years ago
Viewpoint: Digitizing Processes to Align with GMP Requirementsabout 6 years ago
Unlocking the Key Changes to Annex 1about 6 years ago
Strategizing for Rapid Changeovers in Biologics ManufacturingRelated 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.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
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PharmTech AI Pulse Check episode 2 covers AI data governance, API-gated journals, watermarking limits, and why attribution beats detection in GxP.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.