<br />
FEATURED REPORT<br />
Manufacturing Complexities<br />
of In Vivo and Ex Vivo<br />
Gene<br />
Therapies<br />
DECEMBER 2025<br />
01 Building the Future of Gene-Therapy<br />
Manufacturing with Viral Vectors<br />
Andrew Detzel, Christopher Nieder,<br />
Francisco Gonzalez, and Robert Brousseau<br />
04 6HWWLQJ6SHFLȴFDWLRQVIRU&$577KHUDS\<br />
According to Program Development Phase<br />
Alicja Fiedorowicz<br />
10 From Complexity to Control in Cell and<br />
Gene Therapy Analytics<br />
Olympia Pachoumi<br />
18 Operational Agility in Action: A Case<br />
Study of Cross-Border Technology<br />
Transfer for Viral-Vector<br />
Manufacturing<br />
Mark Woodyer, Lee Davies,<br />
and Quentin Bazot<br />
IMAGE BY ADOBE STOCK<br />
(HTTPS://STOCK.ADOBE.COM)<br />
BioProcess<br />
International<br />
It's noisy out there! B<a title="December 2025 - Featured Report page 1" href="https://secure.viewer.zmags.com/publication/0e678168?page=1"> FEATURED REPORT Manufacturing Complexi</a>
<a title="December 2025 - Featured Report page 2" href="https://secure.viewer.zmags.com/publication/0e678168?page=2"> BioProcess International It's noisy out there! </a>
<a title="December 2025 - Featured Report page 3" href="https://secure.viewer.zmags.com/publication/0e678168?page=3"> Building the Future of Gene-Therapy Manufacturing</a>
<a title="December 2025 - Featured Report page 4" href="https://secure.viewer.zmags.com/publication/0e678168?page=4"> developers are researching suspension-culture met</a>
<a title="December 2025 - Featured Report page 5" href="https://secure.viewer.zmags.com/publication/0e678168?page=5"> such as high-performance liquid chromatography (H</a>
<a title="December 2025 - Featured Report page 6" href="https://secure.viewer.zmags.com/publication/0e678168?page=6"> Setting Specifications for CAR-T Therapy Accordin</a>
<a title="December 2025 - Featured Report page 7" href="https://secure.viewer.zmags.com/publication/0e678168?page=7"> ideal specification strikes a balance between acc</a>
<a title="December 2025 - Featured Report page 8" href="https://secure.viewer.zmags.com/publication/0e678168?page=8"> A NUANCED, risk-based approach to specification s</a>
<a title="December 2025 - Featured Report page 9" href="https://secure.viewer.zmags.com/publication/0e678168?page=9"> associated neurotoxicity syndrome, ICANS). For ex</a>
<a title="December 2025 - Featured Report page 10" href="https://secure.viewer.zmags.com/publication/0e678168?page=10"> product quality, sponsors also may justify the re</a>
<a title="December 2025 - Featured Report page 11" href="https://secure.viewer.zmags.com/publication/0e678168?page=11"> and regulatory alignment, but also a deep commitm</a>
<a title="December 2025 - Featured Report page 12" href="https://secure.viewer.zmags.com/publication/0e678168?page=12"> From Complexity to Control in Cell and Gene Thera</a>
<a title="December 2025 - Featured Report page 13" href="https://secure.viewer.zmags.com/publication/0e678168?page=13"> )LJXUH ɄProcess development for cell and gene the</a>
<a title="December 2025 - Featured Report page 14" href="https://secure.viewer.zmags.com/publication/0e678168?page=14"> material, process characterization and monitoring</a>
<a title="December 2025 - Featured Report page 15" href="https://secure.viewer.zmags.com/publication/0e678168?page=15"> process parameters. The platform integrates on- a</a>
<a title="December 2025 - Featured Report page 16" href="https://secure.viewer.zmags.com/publication/0e678168?page=16"> A promising strategy for real-time monitoring of </a>
<a title="December 2025 - Featured Report page 17" href="https://secure.viewer.zmags.com/publication/0e678168?page=17"> Catapult is to combine high-throughput, high-cont</a>
<a title="December 2025 - Featured Report page 18" href="https://secure.viewer.zmags.com/publication/0e678168?page=18"> Photo 1: Technologies such as Roche's LumiraDx mu</a>
<a title="December 2025 - Featured Report page 19" href="https://secure.viewer.zmags.com/publication/0e678168?page=19"> Emerging surrogate markers, enabling techno</a>
<a title="December 2025 - Featured Report page 20" href="https://secure.viewer.zmags.com/publication/0e678168?page=20"> Operational Agility in Action A Case Study of Cro</a>
<a title="December 2025 - Featured Report page 21" href="https://secure.viewer.zmags.com/publication/0e678168?page=21"> )LJXUH ɄProject timeline; QC = quality control, S</a>
<a title="December 2025 - Featured Report page 22" href="https://secure.viewer.zmags.com/publication/0e678168?page=22"> )LJXUH ɄProcess-flow diagram for validating analy</a>
<a title="December 2025 - Featured Report page 23" href="https://secure.viewer.zmags.com/publication/0e678168?page=23"> )LJXUH ɄOperator training overview for (LEFT) ups</a>
<a title="December 2025 - Featured Report page 24" href="https://secure.viewer.zmags.com/publication/0e678168?page=24"> )LJXUH ɄAnion-exchange (AEX) chromatogram (benchm</a>
<a title="December 2025 - Featured Report page 25" href="https://secure.viewer.zmags.com/publication/0e678168?page=25"> · Ensure analytical-method equivalency throu</a>