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BioProcess
International
DIGITAL EDITION
ARCHIVE
September 2022 | Volume 20 | Number 9
www.bioprocessintl.com
BioProcess
International
Covering the whole development process
for the global biotechnology industry
UPSTREAM
PRODUCTION
· Raman Spectroscopy for Upstream PAT
· 20 Years of Upstream Advances, Part 2
· Partnerships in Allogeneic Cell Therapy
· The Relationship Between Quality-Risk
and Knowledge Management
· Applications for Synthetic Biology
· Methods to Derive Mesenchymal
Stromal Cells from Umbilical Cords
• FEATURED REPORT:
Process Monitoring and Control
Quality.
Trust ours to enable yours.
10of10
approved CAR-T and
gene therapies use our
technologies for
product lot release
Trust your gene therapy and vaccine development
to the highest
BioProcess International DIGITAL EDITION ARCHIVE
September 2022 | Volume 20 | Number 9 www.bioproc
Quality. Trust ours to enable yours. 10of10
BioProcess International Highlights . . . . . . .
STRONGER AS ONE One Source WuXi XDC -
SEPTEMBER 2022 www.bioprocessintl.com/eBooks Our
SNAP AND PRODUCE. With the ease of operation of
FROM THE EDITOR J ust coming off our bi
BioProcess Insider The BioProcess Insider digital
BPINSIDER adoption to be achieved by 2030. That o
EMERGING THERAPIES BPI THEATER Improvements an
BPI THEATER EMERGING THERAPIES The Future of A
FOCUS ON... COMPLIANCE Building a Solid
Figure 2: Knowledge management and quality risk m
quality product are clear. But adoption of KM in
Figure 6: The risk–knowledge infinity cycle as ap
Accelerate Your Upstream Process Development with
Figure 7: Knowledge management process model (ada
Look critically at the knowledge captured du
20 YEARS OF BPI Hardware, Software, and Wet
Unlike ZFNs and TALENs before it, the CRISP
nitrogen tanks. To mitigate risks that could comp
Process
ADVANCES RELATED TO CELL-THERAPY SYSTEMS A key di
exchange of groundbreaking information and knowle
FOCUS ON... LOGISTICS Future Supply-Chain
As an allogeneic cell therapy advances to higher-
Because donor starting material can be used to ma
BIOPROCESS INTERNATIONAL IS CELEBRATING OUR 20TH
BIOPROCESS TECHNICAL Synthetic Biology for Ada
established a novel hypoxia-responding cell syste
Phosphorylated NFAT5 enters nuclei and activates
Invites you to become the HERO J
12 Huang YM, et al. Maximizing Productivity
An integrated end-to-end solution for the glob
BIOPROCESS TECHNICAL Raman Spectrometric PAT Mo
to larger process volumes. Noncontact measurement
Figure 4: Raw spectral data from the Ambr and 10-
YOUR THERAPEUTIC Microbial-based Large Molecu
Figure 5: Comparing observed and predicted plots
BIOPROCESS TECHNICAL Deriving Mesenchymal Strom
Figure 1: Umbilical cord lining and Wharton's jel
Figure 2: Morphological differences were observed
We Meet Your Single Use Process Monitorin
PRODUCT PREVIEW - PLANNED AVAILABILITY EARLY 2023
Figure 3: (LEFT) To compare mean ± SD population
Figure 4: To determine the median fluorescence in
ATCC cGMP & cGTP Cell Banking and cGMP Bioreposit
Figure 5: Potency and genetic stability of cultur
Figure 6: Secreted proteins from cells cultured a
gov, 2020; https://ClinicalTrials.gov/show/ NCT04
BIOPROCESS TECHNICAL Opportunities in the Field
culture media, host cell proteins, DNA, monoclona
Figure 2: Control of host-cell impurities Delete
DISCLOSURES Probiomed S.A. de C.V. develops, manu
SUPPLIER SIDE A Plug-and-Produce GMP Plant for C
and liquids through sterile and fully enclosed tu
Figure 1A: Layout of the CliniMACS cell factory i
standardizes a central manufacturing process and
SUPPLIER SIDE Overcoming Challenges in Viral Vect
maturity. Product knowledge, testing, and optimiz
SUPPLIER SIDE Twenty Years of Innovation Reflec
agents and occurrences of cell-line instability c
ASK THE EXPERT Comprehensive Virus Clearance Eva
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ASK THE EXPERT Leveraging Prior Knowledge t
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ASK THE EXPERT Mass Photometric Analysis of Ade
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THE LARGEST BIOPROCESSING EVENT FOR LEARNING HOW
ELU·CIDA·TION Market Growth for Biopharmaceutical
PendoTECH® TFF Process Control System an extrem
DEVELOPING BIOLOGIC DRUGS IS