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« FORMULATION AND DEVELOPMENT
Figure 3. Study Information Workflow
from vendors and within pharmaceutical companies. This presents a
need and opportunity to build an ELN infrastructure that is flexible,
can meet the general requirements of most users and has the
ability to evolve over time. Overall, our successful implementation
and integration of these two powerful platforms, along with
instrumentation and databases, demonstrates that both these vendors
have platforms that can be connected, used and further developed to
meet the future ELN needs of scientists.
Use Case: Dynamic
Procedural Support
Biogen's interest in Next Generation Lab Capture operates on the
premise of establishing a digital standard operating procedure (SOPs)
for routine laboratory operation. We envision the digital SOP as one
of two key input platforms for an information workflow that delivers
scientific information into outputs such as reports and insights. The
second platform involves standardized instrument data and file
structures. A simplified schematic of the digital workflow is shown in
Figure 4. With this approach, our expectation is that treating scientific
information to make it FAIR (Findable, Accessible, Interoperable, and
Reusable) will increase efficiency and create both direct and indirect
value from the application of experimental data.
Currently, the written SOP is interpreted for practical use into
makeshift spreadsheets or ELN templates that provide features of
method guidance, preparative calculations, recording of materials
and equipment, recording of experimental observations, capture
of raw data, data analysis, and summarization of results. These tools
are an interpretation of the written method and have the inherent
risk of being inaccurate or not applicable to the exact laboratory
setting. Moreover, because they require typing, information is often
not recorded in real time. In most cases these tools are not transferred
to receiving laboratories in Quality and CROs who have their own
infrastructure for managing scientific information.
The Apprentice technology offers the promise of an interactive human
readable document that aligns with our vision of a digital SOP. Listed in
Table 1 is a series of features Apprentice offers that effectively captures
the experimental metadata of a laboratory workflow and guide the
operator through the method. Within the Apprentice environment,
we were able to create an annotated SOP from an existing document
(Figure 5). This allowed the document to be interactive, capturing the
procedure in a stepwise workflow that can be consistently executed,
tracked, and confirmed. We were able to complement the process
Figure 4. Laboratory Digital Information Workflow
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APR January/February 2022

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