The primary purpose of an analytical program is not to satisfy the regulatory agencies but to assure success of the clinical program. At Althea we strike a balance between achieving a phase-appropriate understanding of your product and rapid, cost-effective execution of an analytical program.
The primary purpose of an analytical program is not to satisfy the regulatory agencies but to assure success of the clinical program. In order to do that, it is essential that a thorough understanding of the science behind the analytics.
SEPARATION SCIENCE
“Separation science” is a term not heard too often in the biopharmaceutical community, but it’s at the heart of everything we do. Separation science is the study of processes and materials for the separation of specific molecules, usually when these are present in very complex mixtures. It is an enabling science in that it is fundamentally necessary for all subsequent measurements and determinations, as well as purifications.
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PROTEIN SCIENCE
If separation science is the engine that powers the modern analytical laboratory, protein science is its fuel. Without a thorough understanding of the biochemistry and biophysics of proteins, it’s impossible to evaluate the significance of analytical results or even to determine what analytical procedures are appropriate for a given product. What’s more, protein science is at the heart of every aspect of drug development from choice of an appropriate clone to purification and formulation.
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biotech and pharmaceutical companies from pre-clinical development through commercial supply.
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