PharmTech.com Bio/Pharma Outsourcing Innovation eBook 2023 Pharmaceutical Technology
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21
Manufacturing
Scale-out versus scale-up
Changing the scales of an existing facilit y, for ex-
ample, ceiling height, autoclave capacities, f loor
weight loads, gas supply capacities, liquid handling
size units, and seed train changes can be associated
with significant challenges. Consequently, scale-out
is often seen as a more viable alternative to scale-up,
providing manufacturing f lexibility and better adap-
tation to market f luctuations. SUTs are particularly
well-suited for this strategy.
Process validation is also more straightforward; by
using a bracket validation design, no additional valida-
tion is necessarily needed. Scale-out manufacture also
means that in the event of failure (dependent on the
root cause), the entire batch is not lost but rather only
one unit. With more options now available for success-
ful process intensification, scale-out has become an in-
creasingly 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 Intel ligence. Biologics Market – Growth,
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 Scaling 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. Corning. Corning Ascent: Fixed Bed Reactor Sys-
tem: Scaling from Process Development to Produc-
tion with an Attachment-dependent Cell Growth
Plat for m. ht tps://w w w.cor ning.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.
Drug Solutions Podcast: Outsourcing vs. Insourcing in Biopharma:
Determining the Best Strategy: Part 2
Pharmaceutical Technology presents the Drug Solutions podcast, where the editors will chat with industry experts from
across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest ques-
tions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.
In this episode of the Drug Solutions Podcast, Meg Rivers discusses outsourcing strategies in biopharma with Jeff Hen-
derson, key account manager of Vetter. In part two of this outsourcing series, Meg Rivers and Jeff Henderson, key account
manager of Vetter, discuss:
• What the biopharma industry currently tends to outsource
• Outsourcing strategies the biopharma industry should be utilizing
• Internal tasks the biopharma industry should consider outsourcing more in development and manufacturing
• What the biopharma industry should reconsider outsourcing and instead perform in-house
• What organizations are choosing not to outsource and why
• And more
For more podcast episodes, visit our website!
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