PO Q1 2021 - 25

SECTION TITLE
CONTRACT MANUFACTURING

bioreactors and continuous processes. While these are more
productive, they may make it harder to reduce facility footprint.
However, there are ways to reduce the amount of the tradeoff in many
cases. For example, buying a premade solution. To make sure you are
considering all the alternatives, it is important to be working with an
experienced bioprocessing partner who can help provide this insight.

The Future of Process Intensification
While it is clear that PI is becoming more widely adopted in the
biopharma industry, each company must determine how exactly they
can best implement these changes to their current processes. While
there are many benefits, there are also initial upfront investments and
regulatory concerns to factor in.

Industry Challenges
Ideally, an optimized bioprocess would be fully automated. But
this can cause challenges. If the company chooses to implement
automated technologies throughout the bioprocess, they will likely
have issues integrating these solutions if they are from different
vendors. The industry must focus on solutions, such as collaborations
between vendors, that allow these technologies to communicate
with each other if we are going to reap the full benefits of automation.

Regulatory

A good bioprocessing partner can help biomanufacturers understand
if making major changes, introducing a few new technologies, or
maintaining the current workflow is the best decision. A complete
overhaul may not be necessary to receive some benefits. The partner
will consider factors such as molecule, stage of the product, facility
size, current facility setup, manufacturing capacity, currently available
solutions, and timeline needs to help the biopharma make this
decision. If deciding to only intensify one part of the bioprocess, it will
also be important to understand how that change will impact the rest

Companies may be hesitant to introduce process intensification into
their manufacturing workflow because it could disrupt regulatory
processes. If a company is in the late stages of clinical research and
are making significant changes, this could mean major delays or
complications with regulatory approvals while minor changes can be
incorporated more seamlessly. However, if you have good reasoning
and data to justify why the change was made, the FDA may be
more open to working with your company to minimize regulatory
disruptions. It also is important to weigh the savings because even
if there are delays, there could still be long-term advantages that will
make up for the initial loss. Recognizing the importance of process
intensification and continuous manufacturing adoption, the FDA is
dedicating resources to make sure that proper approval pathways
are in place.2 They have also created an Emerging Technology Team
that provides support for navigating the review process for newer
methods, such as this. Ultimately, it pays to plan ahead and to
understand how process intensification may impact your regulatory
situation - but it's not necessarily a dealbreaker.
pharmoutsourcing.com |

of the process and manufacturing network.

References
1. Langer, E., 2021. Biomanufacturing: Demand for Continuous Bioprocessing Increasing Bioprocess Development Forum. [online] Processdevelopmentforum.com. Available at:
.
2. U.S. Food and Drug Administration. 2019. FDA Statement On FDA'S Modern Approach To
Advanced Pharmaceutical Manufacturing. [online] Available at: .

Priyanka Gupta has been working with Sartorius since 2007, where today, she
is the Head of Market Entry Strategy for Protein Based Therapeutics. She holds
a Master's in Chemical Engineering from Florida State University in Tallahassee,
FL. Most recently, she developed process models to understand the economic
impact of implementing Process Intensification for various modalities and
scales. Prior to that, she was a downstream application scientist. Before
joining Sartorius, Gupta was a Process Development Scientist, Downstream at
Amgen for more than four years.
| January/February/March 2021

http://www.Processdevelopmentforum.com http://www.processdevelopmentforum.com/articles/biomanufacturing-demand-for https://www.fda.gov/ http://www.pharmoutsourcing.com

PO Q1 2021

Table of Contents for the Digital Edition of PO Q1 2021

PO Q1 2021 - Cover1
PO Q1 2021 - Cover2
PO Q1 2021 - 1
PO Q1 2021 - 2
PO Q1 2021 - 3
PO Q1 2021 - 4
PO Q1 2021 - 5
PO Q1 2021 - 6
PO Q1 2021 - 7
PO Q1 2021 - 8
PO Q1 2021 - 9
PO Q1 2021 - 10
PO Q1 2021 - 11
PO Q1 2021 - 12
PO Q1 2021 - 13
PO Q1 2021 - 14
PO Q1 2021 - 15
PO Q1 2021 - 16
PO Q1 2021 - 17
PO Q1 2021 - 18
PO Q1 2021 - 19
PO Q1 2021 - 20
PO Q1 2021 - 21
PO Q1 2021 - 22
PO Q1 2021 - 23
PO Q1 2021 - 24
PO Q1 2021 - 25
PO Q1 2021 - 26
PO Q1 2021 - 27
PO Q1 2021 - 28
PO Q1 2021 - 29
PO Q1 2021 - 30
PO Q1 2021 - 31
PO Q1 2021 - 32
PO Q1 2021 - 33
PO Q1 2021 - 34
PO Q1 2021 - 35
PO Q1 2021 - 36
PO Q1 2021 - 37
PO Q1 2021 - 38
PO Q1 2021 - 39
PO Q1 2021 - 40
PO Q1 2021 - 41
PO Q1 2021 - 42
PO Q1 2021 - 43
PO Q1 2021 - 44
PO Q1 2021 - 45
PO Q1 2021 - 46
PO Q1 2021 - 47
PO Q1 2021 - 48
PO Q1 2021 - Cover3
PO Q1 2021 - Cover4
https://www.nxtbookmedia.com