Impurity profiling
The stringent regulatory norms and the efforts for the control of impurities in pharmaceutical produ...
Design of experiment in assessing robustness and qualification of a cell based potency assay
The method was previously qualified in a thaw for use format with a precision of 10% and bias/accura...
Safe Handling of Highly Active Compounds
Our facility located in Lexington, Kentucky is a unique parenteral manufacturing site that uses isol...
The Benefits of Isolator Technology
Isolator technology has become increasing more popular in the use of high-potency drug manufacture....
Using FMEA as a Risk Assessment Technique
Failure mode effects analysis (FMEA) is a form of risk assessment using a step-by-step approach to i...
Cleaning Verification Method by HPLC – UV: How Fast Can We Go?
Cleaning verification represents the start and finish of each batch in pharmaceutical manufacturing....

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