Manufacturing
Principal Scientist Anders Cai Holm Hansen explains how CDMO AGC Biologics uses its global, single-use network and a strategy emphasizing “scale-out” manufacturing, to derisk demand uncertainty, speed timelines and conserve cash for emerging drug developers.
The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial clients as it works to expand the plant’s capacity to 172,000 liters.
In this episode of Denatured, you’ll hear from Jason Jones, head of global business development at Cellular Origins and Alexander Seyf, founder & CEO of Autolomous. They discuss how the push to scale cell and gene therapy manufacturing is accelerating interest in automation, digitization, robotics and deeper collaboration across the ecosystem.
As cell and gene therapy developers face rising pressure to produce therapies faster and at lower cost, the industry is leaning on robotics, digital systems and partnerships to bridge the gap between innovation and delivery.
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.
Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early testing, smart IP and regulatory planning, and scalable CMC choices can help founders reach first-in-human faster.
BioNTech envisioned the site making hundreds of millions of vaccines a year, but has since shifted its pipeline to other modalities while mRNA technology continues to face headwinds in the U.S.
While some large companies could start paying the full tariff in 120 days, many products, including orphan drugs, cell and gene therapies, and antibody-drug conjugates, will enjoy exemptions that waive or greatly reduce the levies.
After Eli Lilly achieved the milestone approval of the weight loss pill Foundayo, Novo Nordisk launched a full-court press to defend oral Wegovy, which has been enjoying a record-breaking launch since January.
As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a resubmission for FDA approval.
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