Company: Bristol-Myers Squibb
Liaison(s): Edward Crabbe
Bristol-Myers Squibb is a New York City
headquartered global biopharmaceutical company
that is actively discovering, developing, and
commercializing therapeutics for serious life-changing
conditions such as HIV and cancer. In 2015, the
publically traded company generated $16.6B in
revenues, invested $5.9B in R&D costs, and holds
a current market cap of roughly $109B as of Q1
2016. Bristol-Myers Squibb has commercialized 12
new medicines within the past 7 years, including the
immuno-oncology drug OPDIVO®, which generated
$942M of revenue in 2015.
Bristol-Myers Squibb employs scale down models of
their large-scale manufacturing processes for process
characterization and improvement. Scale down models
allow for extensive empirical testing that would
otherwise be cost prohibitive at production scale.
While a number of scale dependent process parameters
such as power per unit volume (P/V) and volumetric
mass transfer coefficient (kLa) have been used in
scale down models, limited information has been
gathered on evaluating the best practices for evaluating
performance of scale down bioreactors.
The Bristol-Myers Squibb TMP Team benchmarked
the current scaling best practices reported in industry
and academia. Design of Experiment (DoE) and
Quality by Design (QbD) were then incorporated into
an experimental framework to establish scalability
between bench and production scales. This framework
was subsequently implemented into a bioreactor
study conducted at KGI. The study replicated process
development projects carried out in industry and was
used to validate the team’s experimental methodology.
The experimental framework and data generated from
the study were analyzed, allowing the synthesis of
a roadmap for developing scale-down and scale-up
models. This approach can be used by Bristol-Myers
Squibb Process Scientists for future work. The results
of the work have been communicated to BMS through
regular presentations and a full report that was
completed at the end of the project.
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