Displaying 1–25 of 71 results for Emil W. Ciurczak, Contributing Editor
A review of IFPAC Annual Meeting 2018 from contributing editor Emil W. Ciurczak.
Interviews with product experts about select hardware/software products applicable to PAT/QbD, highlighting key features of each instrument/program
Hand-made to assembly lines, now, to automated production
A new attitude was clearly on display at IFPAC 2017
Trends include continuous manufacturing, biosimilars, supply chain security and smaller instrumentation
There are a number of points of view and opinions on how good or necessary biosimilars actually are
Packaging does much more than serve as a place for the label
Why so many pharmaceutical companies can’t “just do” PAT
Or, what have we forgotten?
Neither rain, nor sleet, nor snow could keep me from finding the lastest technology at IFPAC 2016 conference.
The Continuous Manufacturing (CM) program at Rutgers University continues
Instrument and PAT vendors are continually innovating, unveiling new systems or significant new features at PittCon
Instrument and PAT vendors are continually innovating, and 2015 is no different
The quest for “knowing exactly what’s in the soup”
PAT groups must improvise when validating a process analysis. In many cases, several metrics are not based on current practices
Complexity and lean staff often create a non-compliant operational culture; fortunately there are ways to fight the malaise
U.S. regulators want more than release tests to prove biosimilar safety and efficacy
Time, space, utilities and labor ARE all saved by using continuous manufacturing in lieu of current production methods.
Newer monitoring technologies can provide real insight into solid-dose forms in process
Efficiencies from well applied PAT and QbD principles have the potential to re-align orphan drug cost structures
U.S. regulators are telegraphing plans to reorganize, bucking its resistance-to-change zeitgeist
Conflicting goals between the FDA and Congress are creating an interesting “tug of war” across the Generics space
PAT-based analysis methodologies help see, quality and quantify subtle changes in doasge forms
There were a number of misconceptions (e.g., samples have to be ground, since there is no way to account for particle size) that held back method development in Pharma for years.
Either true or simulated, moving bed chromatography has real potential to speed the flow downstream