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BioProcess
International
DIGITAL EDITION
ARCHIVE
June 2024 | Volume 22 | Number 6
https://www.bioprocessintl.com
BioProcess
International
Covering the whole development process
for the global biotechnology industry
OUTSOURCING
· Planning, Oversight, and Due Diligence
in Technology Transfer
· Digital Platforms for Collaborative
Research and Development
· Emerging CDMO Partnerships Enable
CGT Success
· India and USA Team Up for Drug
Discovery and Development
· Setting Specs for Cleanroom Ops
· Bioreactor Fluid Flow and Mixing
GMP Production Where
and When You Need It.
CAPABILITIES INCLUDE:
Drug Substance (DS) Manufacture
· 262,000 L bioreactor capacity, expanding to 588,000 L by 2026
· Single-use/disposable bioreactors
· Scale-out manufacturing paradigm
· Fed-batch or
BioProcess International DIGITAL EDITION ARCHIVE
June 2024 | Volume 22 | Number 6 https://www.
GMP Production Where and When You Need It. CAPA
BioProcess International Highlights . . . . . .
JUNE 2024 https://www.bioprocessintl.com/eBooks B
FROM THE EDITOR A s you read
BioProcess Insider The BioProcess Insider portal
ARE YOU LOOKING FOR EXPERTS IN MICROBIAL PRODUC
BPINSIDER efficiency of big pharmaceutical compan
)2&86ɊON... PROCESS DEVELOPMENT Keys to Suc
monitoring, including reviews, feedback sessions,
The path to SUCCESSFUL technology transfer is muc
Enable better vaccines with TrypsiNNex® Int
)2&86ɊON... BIOPROCESS 4.0 Transforming Bio
real time, irrespective of geography. They can no
Figure 2:ɄAlthough digital collaboration platform
)2&86ɊON... ADVANCED THERAPIES Elevating th
In the next three to five years, the rise of arti
Companies can significantly ENHANCE their talent
)2&86ɊON... BUSINESS US–India Collaborative I
To support those goals, the Indian governmen
the global magnetic resonance imaging (MRI) equip
FIND US AT BOOTH #4649 AT THE BIO INTERNATI
BIOPROCESS TECHNICAL Extending the Visible Resid
7DEOH ɄFrom three observation angles and lightin
7DEOH ɄVisible residue limit (VRL) testing of cou
Continuing to lead the way in RNA manufacturing
7DEOH ɄSummary of results from visible residue li
Our results were similar for coupons spotte
BIOPROCESS TECHNICAL Establishing a Life Cycle f
particles, such as those that carry microorganism
7DEOH ɄPore size results Sample Reference
preparation. However, the observed particle count
BIOPROCESS TECHNICAL Lessons in Bioreactor Scale
7DEOH ɄComparison of parameters used for calculat
)LJXUH ɄPitched-blade and paddle (Rushton) impell
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)LJXUH ɄThe radial flow pattern induced by Rushto
That fluid stream gets divided in half, with one
)LJXUH ɄMixing times measured in a 400-L stirred
REFERENCES Note: To refer back to part 1,
SUPPLIER SIDE High Aggregate Levels with Enginee
)LJXUH ɄTypical operating ranges for intermediate
7DEOH ɄHost-cell protein (HCP) classification and
ASK THE EXPERT Turning Biologic Innovation into
and filings all meet stringent regulatory standar
ASK THE EXPERT Moving Towards Scalable AAV
scientists ran and analyzed two culture processes
ELU·CIDA·TION Artificial Intelligence Overdrive
Automated Cell Culture Analyzers Test menus speci