Cheryl Platco

Data Integrity Issues in Microbial Testing
Sunday, October 15, 2017
A lack of data integrity often is “just fraud,” says Howard Sklamberg, FDA deputy commissioner for global regulatory operations and policy. read more
Data Integrity Issues in Microbial Testing
Tuesday, October 10, 2017
A lack of data integrity often is “just fraud,” says Howard Sklamberg, FDA deputy commissioner for global regulatory operations and policy. read more
Resolution of Low Endotoxin/ Lipopolysaccharide Recovery (LER/LLR)Testing
Saturday, July 30, 2016
The Low Endotoxin (LER) and Lipopolysaccharide Recovery (LLR) phenomena have been debated as a Limulus Ameobocyte Lysate (LAL) test validity issue peculiar to therapeutic monoclonal antibodies for over three years. The FDA... read more
Understanding the Limulus Amebocyte Lysate and Rabbit Pyrogen Tests for Low Endotoxin Recovery Studies
Wednesday, September 30, 2015
The use of purified lipopolysaccharide (LPS) as a surrogate contaminant for natural endotoxin currently remains a controversial and misunderstood subject. Soon after the FDA published a questions and answers document1 ... read more
Low Lipopolysaccharide Recovery versus Low Endotoxin Recovery in Common Biological Product Matrices
Monday, September 01, 2014
Low endotoxin recovery (LER) was first described publicly at the PDA Annual Meeting in Orlando Florida, in April, 20131 but the phenomenon has been observed by pharmaceutical scientists for years, mostly as classical “... read more

Cheryl Platco

Articles by Cheryl Platco

Data Integrity Issues in Microbial Testing

Data Integrity Issues in Microbial Testing

Resolution of Low Endotoxin/ Lipopolysaccharide Recovery (LER/LLR)Testing

Understanding the Limulus Amebocyte Lysate and Rabbit Pyrogen Tests for Low Endotoxin Recovery Studies

Low Lipopolysaccharide Recovery versus Low Endotoxin Recovery in Common Biological Product Matrices

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