Bioprocessing is an endeavor with some specific challenges associated with it, such as how we might implement single-use technologies or gain regulatory approval for new drugs. It
seems to me, however, that it is easy to become so focused on topics such as
these that we overlook applying established methods and practices used in a
broad array of industries to improve our own. One such framework that could be
applied to our sector is an analysis of the 4Vs of volume, variety, variation
and visibility. Considering these parameters can help us make decisions about
how to best organize biopharmaceutical manufacturing operations.
Volume: The number of doses of
a biopharmaceutical to be manufactured varies considerably between drug
products. Blockbuster products and products used to manage chronic diseases
over long periods of time might be manufactured in large volumes. Due to the
specific nature of biopharma drugs the patients that will respond to them can
be small and the number of doses required not nearly so many. Orphan drugs for
treating relatively rare diseases are a good example of products where the
number of doses per year to be manufactured might be very low. Taking this to
an extreme, personalized medicines and cell therapies are likely to be required
is such small volumes that they are challenging existing industry processing
technologies, supply networks and regulatory frameworks in order that they can
be successfully commercialized.
Variety: Often linked by an inverse
relationship to volume, variety refers to the number of different products an
operation must deliver. In the above example of personalized medicine the
variety of products to be produced may be very high as the products are in
essence customized to the patient receiving them. Less variety tends to imply
higher volume production and perhaps less operational complexity.
Biopharmaceutical companies often strive to develop platform manufacturing
processes capable of delivering a variety of products within their portfolio
without adding to this complexity.
Variation: The degree to which
demand for the product varies can have a significant impact on operation
design. This variation can be more predictable, such as with the seasonal flu
vaccines or less predictable, perhaps driven by competitor or regulatory
activity. Responding to variations in demand can be a significant challenge for
the biopharmaceutical industry where making process changes including process
scale-up be a slow process with technical and regulatory challenges. Failure to
design operations with sufficient agility to respond to demand fluctuations can
result in increased lead times and patients not receiving medicines at the time
they are required.
Visibility: Biomanufacturing
operations are typically exposed to a high level of internal and external
scrutiny due to the regulated nature of the industry. Process visibility is a
term often used to describe operations that deliver services in which the customer
is typically heavily involved in their design and operation. An example in
biologics manufacturing are the use of Contract Manufacturing Organizations
(CMOs). Once the decision has been made to outsource production, the management
of the relationship between customer and contractor must be given significant
attention to ensure successful delivery of drugs to patients and the sponsor
must address issues such as relinquishing of some control.
Consideration of the 4Vs can
help shape the design of biomanufacturing operations. For instance, high
volume-low variety operations are typically more repetitive in nature and may
suggest continuous biomanufacturing is an appropriate strategy. Companies
requiring a small number of doses of a large number of products will need to design
operations that permit a greater level of complexity and more intermittent processes.
It is a framework worth reviewing when considering the future design of
your companies bioprocessing footprint.
Join me at #BPIconf
Contact me at nick.hutchinson@parker.com
Dr Nick Hutchinson has a Masters and Doctorate in
Biochemical Engineering from University College London, UK where he focused on
laboratory tools for rapid bioprocess development and characterization. He then
worked at Lonza Biologics in an R&D function investigating novel methods
for large-scale antibody purification before moving to an operational role
scaling-up and transferring manufacturing processes between Lonza sites in the
UK, Spain and USA. Nick now works in Market Development at Parker domnick
hunter where his focus is in bringing Parker's strengths in Motion &
Control to Bioprocessing. This will enable customers to improve the quality and
deliverability of existing and future biopharmaceuticals.
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