Displaying 1–25 of 52 results for Aegis Analytical
Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing.
New enterprise manufacturing process intelligence software capabilities expand Accelrys' footprint in downstream product development and commercialization operations.
While U.S. drug products are of high quality, there has been an increasing trend towards manufacturing problems, resulting in recalls, disruption of operations and drug shortages. Companies are missing billions of dollars of potential additional revenue, and necessary medications are sometimes ...
Aegis Analytical Corporation, in conjunction with Pharmaceutical Manufacturing Magazine, conducted a survey of pharmaceutical and biotech manufacturers in order to better understand current practices for gathering and analyzing manufacturing process data. This paper summarizes the key trends and ...
Software Suite Delivers Extended Data Platform to Third Party Applications
Critical to any PAT effort is having a single point of easy, on-demand access to all relevant data, in a context thats meaningful to diverse groups of users. But data must be presented in a way that facilitates the identification and understanding of cause-and-effect relationships. Justin Neway,...
Quality by Design is breathing new life into quality systems and process analytical technology.
A quick check of the fundamentals will help you approach manufacturing analytics with the right statistical mindset.
Aegis Analytical's Justin Neway goes into further detail on the necessity of process development and manufcturing being on the same team in this audio presentation.
Implementing a new IT paradigm for on-demand data is as much an organizational issue as it is a technological one.
Predictable outcomes lead to greater manufacturing efficiency and speed time to value.
As process manufacturers search for ways to trim costs and boost revenue whether that be by increasing yield or speeding time to value they can view the FDAs inspections and PAT recommendations as opportunities to better understand manufacturing processes across the organization. Todays IT ...
When it comes to reducing technology transfer risk, the secret sauce is really process understanding. The desired state for manufacturing is a design based on a mechanistic understanding that provides real-time quality assurance (rather than expecting quality to be tested in).
Life-science companies that adopt quality by design (QbD) into their overall operations are expected to achieve the desired state of manufacturing. So concludes the Q10 document from the EMEA, US FDA, and the International Conference on Harmonisation of Technical Requirements for the ...
In part two of a video interview taped at Interphex 2008, Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing with Editor-in-Chief Agnes Shanley.
In this video interview taped at Interphex 2008, Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing with Editor-in-Chief Agnes Shanley.
In a recent talk, Ajaz Hussain, former FDA Deputy Director of the Office of Pharmaceutical Science (OPS), reminisces about the Agency's 21st Century initiative and looks ahead to challenges yet to be addressed.
This year's event builds upon the success of the 2005 show, with increases in both exhibitors and educational sessions.
Process improvement and Quality by Design become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time instead on productive science-based collaboration. This is the best way to undertake the ...
When is an aspirin tablet like a yacht? According to Jack Carroll, the answer to this riddle lies in five S-factors: Staff, Select, Strategize, Spend and finally, Supplant a GMP-tested product line with its parallel PAT counterpart.