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CBER director offers a candid take on industry challenges
Tuesday, October 06, 2026
During the keynote at ARM’s Meeting on the Mesa, Karim Mikhail, recently selected to lead CBER after serving as the center’s acting director, offered a candid look at the challenges regulators face in accelerating the development of ...
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Putting a cost model behind Treg manufacturing
Thursday, October 01, 2026
Esmond Lee, senior scientist at the Singapore-based research institute, set out the work in an interview at Sartorius's Process Intensification Forum in Hyderabad, India.
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CDMO roundtable: How can sponsors and CDMOs better align on timelines and IP expectations?
Tuesday, September 22, 2026
We invited cell and gene therapy CDMOs to discuss the most common pressure points in sponsor relationships.
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Exclusive: Behind the scenes of the Kincell-Cellipont merger
Thursday, September 17, 2026
Kincell Bio and Cellipont Bioservices have completed their merger to form Kincellis Advanced Therapies, bringing together complementary cell therapy platforms, 140,000 square feet of manufacturing space and more than 250 employees across ...
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Solving the viral vector bottleneck
Wednesday, September 16, 2026
While gene therapies have demonstrated transformative clinical benefit, their adoption remains limited by manufacturing challenges and cost.
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Scaling the next generation of cell therapies
Wednesday, September 09, 2026
Cell expansion has evolved from a necessary manufacturing step into one of the defining challenges of modern cell therapy, sitting at the intersection of biology, engineering, manufacturing and quality. As the field expands into new ...
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RNA rocks on
Tuesday, September 01, 2026
As the next generation of RNA therapeutics takes the CGT stage, the technology is moving beyond its COVID-era breakout role. It could enable new approaches to in vivo CAR-T, address diseases beyond the reach of conventional gene replacement...
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Global by default
Wednesday, August 26, 2026
For many CGT companies, the U.S. has long been the default starting point for new ventures. In recent years, that model appears to be weakening, as more companies look beyond the U.S. earlier in their development.
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RNA's comeback tour
Wednesday, August 19, 2026
RNA’s reputation may have been forged by a pandemic, but its future will likely be determined by something far less dramatic: the steady accumulation of clinical data, regulatory milestones and, ultimately, patient benefit
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CGT’s unfinished business
Monday, August 17, 2026
Developers who build regulatory strategy into their manufacturing planning from the outset and design to the highest applicable cross-regional standard, will be better positioned to navigate complexity and deliver therapies to patients.
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CDMO roundtable: Who owns risk? How are you improving knowledge transfer?
Monday, August 17, 2026
We invited cell and gene therapy CDMOs to discuss the most common pressure points in sponsor relationships.
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What cell and gene therapy CDMOs want sponsors to know
Tuesday, August 11, 2026
In this roundtable series, CDMOs describe what works — and what doesn’t — in sponsor relationships
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