10 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m
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Measurement Science
P
recompetitive research is increasingly being considered as a
cost-effective way to find solutions to widespread problems
in the bio/pharmaceutical industry and advance innova-
tions for the benefit of patients. Christopher Welch, PhD,
is principal with consulting firm Welch Innovation and serves as
the director of the Indiana Consortium for Analytical Sciences and
Engineering, a joint venture between Purdue University, the Uni-
versity of Notre Dame, and Indiana University. Welch spoke with
Pharmaceutical Technology about trends in pharmaceutical analy-
sis, the advantages of precompetitive research, and the consortium's
planning of a proposed Center for Bioanalytic Metrology, sponsored
by the National Science Foundation (NSF).
Trends
PharmTech: What have been the most significant developments for
pharmaceutical analysis in recent years?
Welch: I see a lot of different threads coming together, making this
a very exciting time for the field of pharmaceutical analysis. Over
the past few years, the requirement to quantify potential mutagenic
impurities at very low levels has created a real need to increase the
sensitivity of analytical methods, leading to a focus on maximizing
signal, minimizing noise, and the widespread adoption of mass spec-
trometry detection in chromatographic QA/QC [quality assurance/
quality control] testing. Supercritical f luid chromatography (SFC)
has long been the preferred analytical technique for stereochemi-
cal analysis in non-GMP pharmaceutical research, but in the past
few years it has finally broken through to become a staple in GMP
analytical testing to support pharmaceutical manufacturing. This
Precompetitive Research
Spurs Innovation in
Pharmaceutical Analysis
Industry–academia
collaborations, such as the
Indiana Consortium for
Analytical Sciences and
Engineering's proposed
Center for Bioanalytic
Metrology, seek to address
unmet needs in measurement
science.
Jennifer Markarian is
manufacturing editor at
Pharmaceutical Technology.
Jennifer Markarian
