Drug Delivery
In this webinar, experts from SK pharmteco’s European and North American sites share practical experience addressing these challenges across the linker-payload development lifecycle—from facility and containment strategy through process and analytical development, scale-up, cleaning, and final product release. Case-based examples will illustrate how integrated chemistry, engineering, analytical, and industrial hygiene strategies can reduce technical risk and support the rapid transition of emerging ADC programs into GMP manufacturing.
FEATURED STORIES
Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies.
After mastering mass-market mRNA production during the pandemic, the industry now needs to achieve the timely delivery of individualized vaccines to thousands of patients.
Thanks in part to the revolution cell therapy brought to treating blood cancers, the modality is now showing promise in some autoimmune applications. This expansion is poised to yield even wider benefits.
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With sales of the oral GLP-1 medicine rising quickly, executives reassured investors that Novo has secured production capacity to support continued growth.
Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
Aside from its manufacturing and distribution footprint, ITM Isotope Technologies Munich will give Telix Pharmaceuticals the late-stage ITM-11, being developed for gastroenteropancreatic neuroendocrine tumors. The asset was rejected by the FDA last month for manufacturing concerns.
The market approval for Fayuvi, which was rejected in 2025 due to manufacturing problems, comes shortly after Ultragenyx got the FDA nod for its first gene therapy last month.
Learn what manufacturing challenges lie ahead, how to equip your team to protect your program from avoidable manufacturing and regulatory setbacks and forge partnerships that can withstand the next five years of industry turbulence.
After reviewing Bausch & Lomb’s response to its observations, the FDA questioned whether the company is committed to implementing significant design remediations.
The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.
GSK is consolidating its vaccine manufacturing operations to one site—located in Canada—amid the pharma’s recent $2.5 billion savings campaign.
After years of price pressures, the trade group argues “the economics of generics have deteriorated to the point where sustainability of the industry is in peril.”
Scholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party manufacturer.