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Articles by Phil DeSantis
Aligning Environmental Monitoring Expectations with Scientific Realities
Introduction The global healthcare industry supplies parenteral products providing patient treatment. These products require rigorous control of contaminants.
01.11.21 -- The AAV Vector Challenge With Selecta's Dr. Carsten Brunn
Article | By Bruce C. Simpson, Thermo Fisher Scientific The most common storage is ultra-low temperature storage, but the fastest growing is cryogenic, in vapor-phase liquid nitrogen. This transition is huge. Chain of temperature and custody data is imperative. Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing This is the first installment in a three-part series that examines the causes of protein aggregation and practical steps you can take to mitigate the risk.
12.03.20 -- Advancing The State Of Aseptic Processing: Let's Get Serious
By Phil DeSantis It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination to result in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.
Advancing The State Of Aseptic Processing Let’s Get Serious Original
By Phil DeSantis Having spent over 50 years in the pharmaceutical industry, I have reached a state of frustration so great that I am almost at the point of doing something that I have never really considered… retiring.
Commentary: Performance fees - new hope for active managers?
In 1994, Jeff Bezos founded Amazon.com, which from humble beginnings created the "Amazon effect" that would redefine customer experiences and distribution. Twenty-five years after its creation, Amazon proved it could modernize distribution in any industry with a relentless focus on giving consumers the edge. Amazon changed the rules, and not every retailer was prepared to play the new game. The same is true in asset management today.
Facilities And Equipment Risk Management A Quality Systems Approach
This two-part article focuses on risk management of facilities and equipment. It describes how a risk-based approach to facilities and equipment management fits into an integrated, effective quality systems structure. The principles discussed are equally applicable to all quality systems. The focus is on facilities and equipment because they represent a broad range of risk to product quality and are one of the key quality systems commonly identified in the pharmaceutical manufacturing industry.
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