www.biopharminternational.com Partnerships for Outsourcing eBook May 2023 BioPharm International
®
23
Manufacturing
Process validation is also more straightforward;
by using a bracket validation design, no additional
validation is necessarily needed. Scale-out manu-
facture also means that in the event of failure (de-
pendent on the root cause), the entire batch is not
lost but rather only one unit. With more options now
available for successful process intensification, scale-
out has become an increasingly attractive option to
ATMP manufacturers.
Key lessons
There are many important considerations that must
be made when scaling processes for ATMP produc-
tion. Offering f lexibility as well as scalability, SUTs
are well-suited to ATMP manufacturing, particularly
when scaling out. With advancements in SUTs and
their availability in varying sizes, the adoption of these
technologies is likely to become increasingly more pop-
ular. However, manufacturers will still face challenges
when scaling with SUTs and will need to understand
and consider all process parameters that may be im-
pacted at changing scales.
References
1. Mordor I ntel l igence. Biologics Market– Grow th ,
Trends, COVID-19 Impact, and Forecasts. 2022–2027
(accessed March 2022).
2. B o y d Te c h n o l o g i e s . T h e R i s e o f S i n g l e - u s e
Bioreactors: Why Make the Switch? www.boydtech.
com. June 21, 2018.
3. Pharmaceutical Technologies. The Logistics of Ex-
tending the Footprint of Advanced Therapy Trials.
www.pharmaceutical-technology.com. Sept. 14, 2021.
4. Stanton, D. Update: Thermo Fisher Sca ling Sin-
gle-use Bioreactors Up to 5,000 L . w w w.biopro-
cessintl.com. Sept. 25, 2019.
5. Pall. Improve Productivity and Reliability of our
Critical Upstream Operations by Investing in the
Right Cell Culture Technology Solutions. https://
www.pall.com/en/biotech/technologies/cell-culture-b.
html (accessed March 2022).
6. Corning. Ascent FBR System: Adherent Cell Biore-
actor System. https://www.corning.com/worldwide/
en/products/ life-sciences/products/ bioprocess/as-
cent-f br-system.html (accessed May 2022).
7. Cor n i n g. Cor n i n g A s ce nt: Fi xe d B e d R e a c t or
System: Sca l i ng f rom P rocess Development to
Production with an Attachment-dependent Cell
Growth Platform. https://www.corning.com/catalog/
cls/documents/brochures/CLS-BP-050.pdf (accessed
March 2022).
8. BioPhorum. Justification of Small-Scale Models:
A n i ndust r y Perspec t ive. w w w.biophor um . com.
May 5, 2021 ■.
Hanns-Christian Mahler
is Chief Enablement Officer (CEO)
& Board Member, ten23 health.
Andrea Allmendinger, PhD,
Chief Scientific Officer at
ten23 health.
Considering Biologic Drug Development
and Manufacturing Holistically
In this episode of BioPharm International
®
's sister
publication, Pharmaceutical Technology
®
's, Drug Solutions
podcast, Felicity Thomas, European/Senior Editor, talks
to Hanns-Christian Mahler, CEO and board member, and
Andrea Allmendinger, chief scientific officer, both at ten23
health—a contract development and manufacturing
organization dedicated to human-centric and sustainable
pharmaceutical development—about some of the
hurdles facing developers and manufacturers of biological
therapies. Hanns-Christian and Andrea take a closer look
at some of the solutions being used within industry to
overcome these challenges and focus on the issue of
sustainability within this sphere. Finally, they touch upon
some of the other potentially important future trends that
will impact biologic drug development and manufacturing.
For more podcast episodes,
visit PharmTech.com!
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