The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
|Articles|March 2, 2020
- Pharmaceutical Technology-03-02-2020
- Volume 44
- Issue 3
Double Planetary Mixer
The Double Planetary Mixer from Ross is scalable through 1000-gallon production models and is offered in a sanitary turnkey configuration that features a stainless-steel workbench for the mixer and discharge system.
The Double Planetary Mixer from Ross is scalable through 1000-gallon production models and is offered in a sanitary turnkey configuration that features a stainless-steel workbench for the mixer and discharge system.
The sanitary four-gallon Double Planetary Mixer & Discharge System Model DPM/DS-4S (pictured) includes type 316 stainless steel on the interior and exterior, electropolished to a 150-grit (#4) finish. The mixer’s jacketed mixing vessel and high viscosity blades are equipped to produce thick gels, pastes, putties, and other semi-solids at precise temperatures. The sealed gearbox and stirrer shafts guarantee complete cleanability and eliminate cross-contamination between batches.
Articles in this issue
over 6 years ago
Drug Production Draws Multiple Contendersover 6 years ago
Coronavirus Response: Reaction or New Reality?over 6 years ago
Embracing Change Managementover 6 years ago
Isolator Head for Microbial Air Samplingover 6 years ago
Compressor-Free Plate Sealerover 6 years ago
Double Clamshell Barrel Continuous Processorover 6 years ago
Challenges in Clinical Manufacturing for Topical Drugsover 6 years ago
Stability Testing: The Crucial Development Stepover 6 years ago
Keeping Toxicity to a Minimumover 6 years ago
Noteworthy Historical Cases of Adverse Drug ReactionsRelated to this article
Regulators will test pharma companies against their own internal AI policies. Jaenisch, Muraru, and Pandey explain how to build defensible, inspection-ready AI practices.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how its connected technology can enhance anticounterfeiting and how data are handled within the product.
Celtic Renewables won the CPHI Award for Sustainable Pharma Excellence for its green chemicals used in pharmaceutical manufacturing. Bettina Brierley, chief commercial officer, talks about the adoption, capacity, and pricing of biosolvents.
Terry Katz, CEO and cofounder of ForgeStop Technology Corporation, explains the company’s CPHI Award-winning connected product technology and how it helps to combat drug counterfeiting.
FDA approved pimicotinib for TGCT based on a 56% response rate; its Project Orbis review signals tighter global launch planning for manufacturers.
Bettina Brierley, chief commercial officer at Celtic Renewables, discusses commercialization of biosolvents for pharmaceutical manufacturing.
From AI validation to microstructure imaging, AAPS PharmSci 360 speakers pushed toward faster drug development backed by stronger evidence. Here are PharmTech's biggest takeaways.
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