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Pharmaceutical Sciences
is housed at four sites: Summit, N.J., for pharmaceutical development,
analytical chemistry and strategic planning; Kenilworth, N.J., for
quality assurance and clinical supplies; Union, N.J., for chemistry
development and biotechnology development; and Lucerne, Switzerland,
which maintains a full slate of functions. The key deliverables
from Pharmaceutical Sciences are clinical supplies, CMC registration
dossiers, scaled processes for active pharmaceutical ingredient
and drug product, analytical methods specifications and devices
packages.
The breadth and depth of this operation underscores the important
role Pharmaceutical Sciences plays in shepherding products through
clinical development and product registration, and afterward, through
life-cycle management. These products range from small molecule
chemical entities to the highly complex biological molecules emerging
from the biotechnology discovery programs. Though primarily a development
group, its analytical, organic and physical chemists, biochemists
and chemical engineers first get involved in the late stages of
product discovery, providing the chemical and pharmaceutical product
characterization data essential to selecting the right molecule
to progress into development.
The critical path for Pharmaceutical Sciences, starting from the process for making the active pharmaceutical ingredient from discovery, is to develop and scale it up from gram to kilo amounts that are sufficient for toxicology studies and initial clinical trials. Typically, a new chemical synthesis is discovered and developed to produce the drug needed for later development.
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