P. R. McAllister

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The ability to prepare consistent biopharmaceutical products depends extensively on possession of banked and characterized cell substrates and on development of production processes which can be validated. While the attributes that define cell characterization have been extensively detailed by ICH and the regulatory agencies in the past decade, little has(More)
For products derived from continuous cell lines, regulatory agencies worldwide require that the purification process be validated for its ability to remove or inactivate potential contaminants such as viruses and virus-like particles. New guidance suggests a requirement for statistical evaluation of these studies but the industry has yet to develop such(More)
A new series of phosphonium salts was examined for effects on the cholinergic nervous system of Schistosoma mansoni. Studies were conducted using both an activity-monitoring and fluorescent-labeling technique. The activity method gave more definitive results, indicating that some poly(methylene)bis(triphenylphosphonium) salts and some(More)
Juxtaposition of the atrial appendages is a rare congenital cardiac anomaly almost universally associated with severe conotruncal abnormalities, especially transposition of the aorta. This presentation describes a case of right sided juxtaposition of the atrial appendages without concomitant conotruncal malformations. This finding contradicts previous(More)
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