Manufacturing
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the design of their facilities.
After years of contraction, investors see biotech reentering a growth cycle driven by scientific progress, asset quality and renewed conviction in oncology, obesity and neuroscience innovation.
AstraZeneca has risen as one of pharma’s most prolific investors in China, including a $630 million pledge last week for full rights to AbelZeta’s cell therapy for cancer.
Cellares, which last year became the first company to receive the FDA’s new advanced manufacturing technology designation, expects to support clinical production this year and offer commercial-scale manufacturing services in 2027.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
True inspection readiness is about the integrity of a company’s entire system.
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
Genentech, a member of the Roche Group, plans to open the facility in 2029 to ramp up capacity to make obesity candidates, including the dual GLP-1/GIP receptor agonist CT-388.
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies including Novo Nordisk see hurdles to implementing the changes.
With inspections always on the table, LOTTE Biologics is pushing a proactive, quality first culture across its dual hubs in Syracuse and Songdo, backing its new single‑use ADC facility with rigorous training, self‑audits and real‑time regulatory surveillance.
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