FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
|Articles|January 1, 2016
- Pharmaceutical Technology-01-02-2016
- Volume 40
- Issue 1
Kneader Extruder
The Ross AMK Kneader Extruder combines the technologies of a double-arm mixer with an extrusion screw.
The Ross AMK Kneader Extruder combines the technologies of a double-arm mixer with an extrusion screw. The sigma blades of the extruder turn at different speeds and opposite reversible directions. During the mix cycle, the extrusion discharge screw assists in cutting and reducing solids while continuously moving materials within reach of the mixing blades. Once mixing is complete, the discharge screw is reversed and utilized to empty the trough. The extruder comes in sizes from 2 to 4000 liters and is available in both Class IV strength (low to mid-range horsepowers) and Class V strength (high horsepowers).
Articles in this issue
almost 11 years ago
Parenteral Packaging: 2021almost 11 years ago
Politics and Pricing Will Challenge Manufacturers in 2016almost 11 years ago
Managing Market Expansion’s Effect on Proceduresalmost 11 years ago
Phase-Appropriate Formulation and Process Designalmost 11 years ago
Reducing the Documentation Burden in Process Validationalmost 11 years ago
Reducing the Environmental Impact of Manufacturingalmost 11 years ago
Cleaning Limits—Why the 10-ppm Criterion should be Abandonedalmost 11 years ago
Using Deterministic Container Closure Integrity Testingalmost 11 years ago
The Market Consolidates for Better Servicealmost 11 years ago
Global Drug DirectionsRelated to this article
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.
Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
MASH and cardiomyopathy AI collaboration: AstraZeneca pays insitro $40M upfront for target discovery, then leads clinical development and CMC planning.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
NVIDIA’s $250M, five-year compute donation funds UK agentic AI safety research, with implications for how GMP teams validate and govern autonomous AI.
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