PO Q1 2021 - 22

CONTRACT MANUFACTURING

Adapting Bioprocessing to Meet
the World's Changing Demands
Priyanka Gupta
Head of Market Entry Strategy for Protein Based Therapeutics
Sartorius

One key decision point is deciding on a bioreactor. There are fedbatch bioreactors (all materials are input and harvested at the same
time) and perfusion bioreactors (actively replaces cell media and
retains viable cells that allows product to be constantly harvested).
Switching to a perfusion stage bioreactor can improve productivity
three to tenfold.

Among the many lessons learned during the COVID-19 pandemic is
the need for large biopharma companies to be able to pivot quickly
to meet emerging threats and demand for novel products. While this
redirection typically costs time and money, there is significant room
for efficiency if the right tools are in place. Many of these fall under
the umbrella of Process Intensification (PI). While PI may not be the
right decision for every company, we aim to provide some of the key
considerations to determine if this is the right approach for you.

Another important component is data modeling and analytics.
Modeling can provide your team with quantitative insight about
how decisions will improve processes, which helps teams understand
what is worth the most investment. High-throughput data collection
tools can help feed these models and allow them to provide better
insight as well.

The Basics of Process Intensification
Process intensification is a holistic framework to maximize overall
productivity. This can be done by increasing productivity through
implementation of process changes, reducing timelines, decreasing
footprints, decreasing costs, and improving flexibility. The concept is
by no means a new one, but it has become increasingly popular in
recent years, and we expect this trend to continue in 2021 as we see
the need for fast and flexible bioprocesses increase.1

Reduced Timelines
To reduce timelines means to decrease the amount of time it takes to
bring the product through the manufacturing cycle to market. This
is especially important when companies are competing with others
to be the first to market with a product for a new indication or for a
product that is the first of its kind, like a biosimilar after a biologic's
patent has recently expired.

Clearly, creating a more efficient bioprocess is a positive thing, but the
benefits get a little more granular than just saving time and money.
They can also make the company more agile, which is increasingly
important. The COVID-19 pandemic underscored the need to pivot
quickly. Facilities that were making a whole host of other therapeutics
must now manufacture vaccines against SARS-CoV-2. Process
intensification can help make this redirection more realistic by not
only allowing the biopharma to operate with more flexibility but also
by offsetting the costs and time typically lost when straying from the
original plan.

Timelines can be decreased by leveraging high density cell banks.
This reduces the growth steps usually needed in a seed train. Another
option is to add a perfusion bioreactor at the N-1 stage. This is just in
the seed train before the production bioreactor. This method allows
manufacturers to not completely switch over to perfusion bioreactors
but instead implement a hybrid option that can still save days on
production time. Compared to other options like dynamic perfusion,
this is also much easier to implement. Additionally, timelines can
be improved by transitioning from stainless steel bioreactors to
single-use products. Along with added flexibility that makes it easier
to switch more quickly to other products or batches, single-use
technologies typically require much less downtime to operate and
are quicker to scale up production.

There are five main pillars of process intensification that we outline below.

Increased Productivity
This refers to making more of the product with a decreased or
similar amount of a different metric, such as time, footprint, or cost.
Productivity can be accomplished in many ways.
Pharmaceutical Outsourcing |

| January/February/March 2021

PO Q1 2021

Table of Contents for the Digital Edition of PO Q1 2021

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