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Science & Innovation

Analytical Science in Drug Development and Manufacturing

Analytic ScienceOf all the many contributors to the drug development process, analytical scientists are critical, yet sometimes overlooked and underappreciated. Without the efforts of this dedicated group of researchers, medicines would not make it to the patients who need them.

Pharmaceutical companies want to ensure that their medicines are effective with acceptable risk profiles. Such quality assurances rely on the roles of analytical scientists whose work informs each step from drug design and formulation through manufacturing, packing and storage.

In the early stages, analytical scientists help characterize and interpret the molecules that serve as the active drug ingredients in new medications. Chemists, structural biologists, pharmacists and allied scientists apply their expertise to determining the structure, function and manufacture of such molecules, which can be small molecules, peptides, proteins or conjugates. Their work predicts how a molecule should act in the body and identifies adjustments to improve the efficacy or safety profile.

For example, when designing a biologic therapy, such as an enzyme replacement therapy (ERT), analytical scientists ensure that the manufactured protein subunits that comprise the man-made molecule of the treatment are assembled to be structurally in the right place in three dimensions.  If one fold is off by a few degrees, the therapy might not be able to bind to its target receptor, leading to off-target binding or none at all, negating the intended effect and possibly causing adverse events.

Based on the scientists' analyses, the design of a molecule and its formulation with other inactive ingredients in the medicine can be tweaked to improve delivery, safety profile, mechanism of action and duration of effect.  Their subsequent characterization of a therapy's physical and chemical aspects contributes to the documentation required by regulatory agencies for initial design concept reviews through filing for approval considerations.  Such data are necessary for the development of novel therapies as well as reformulated treatments.  

In planning later stages of a drug on its road to commercialization, analytical scientists assess the manufacturing process, creating quality and validation tests for each batch to ensure the medicine is not contaminated and fulfilling other requirements that satisfy the FDA-mandated current Good Manufacturing Practices (cGMP).1 They also test the stability of products to ensure that as they journey through the supply chain to the patient, the medicine remains stable.

Analytical scientists use highly sophisticated software, tools and instruments, such different kinds of chromatography or spectrometry, to help assess the individual components of a compound, for example when checking the purity of a sample. Some of the work requires the development of custom ingredients, or reagents, to perform tests on novel compounds. 

The field of analytical science is incredibly dynamic with a singular focus on providing life-changing medications for patients who need them.  As such, the dedication and hard work of the individuals who dedicate their careers to this discipline are impacting the lives of patients every day.

References

  1. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

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