Beyond OEB5: Is OEB6 really the next standard for high-potency pharma?
Few areas of pharmaceutical manufacturing have attracted as much investment in recent years as high-potency containment. The expansion of oncology…
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Oral solid dose at a turning point: Scaling for the next generation of therapies
As the first oral GLP-1 receptor agonists launch in 2026, we are reminded yet again of the enduring importance of…
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How China’s rise as a biopharma innovation hub is reshaping global dealmaking strategies
A new Intelligence Briefing from GlobalData Healthcare suggests that China is becoming an increasingly strategic component of international growth strategies…
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Why Most FDA Warning Letters Share a Single — and Fixable — Root Cause
When a warning letter from the U.S. Food and Drug Administration (FDA) lands on a quality leader's desk, the instinct…
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What drives time-to-randomization in oncology trials?
In the United States, an estimated 2,041,910 new cases of cancer were diagnosed in 2025, with 618,120 people dying from…
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How DFE Pharma supports confident continuous manufacturing decisions
For pharmaceutical manufacturers, the question is whether a specific formulation can perform consistently under continuous conditions. That requires evidence on…
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The rare disease revolution: The state of play for CGTs in orphan diseases
Rare diseases are chronic conditions that affect between 3.5% and 5.9% of the global population. About 80% of rare diseases…
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Develop site-centric protocols to optimize enrollment and maximize performance
In an attempt to meet regulatory expectations, clinical trials are challenged by highly complex protocol design. But these study plans…
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Remedying the paper trail: Manufacturing a digital route to compliance
Regulatory investigators’ remit extends beyond routine standard operating procedure (SOP) reviews; they watch how operators work, how equipment is qualified,…
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How to avoid common contamination control mistakes in new aseptic facilities
Rising biologics approvals worldwide are driving demand for sterile manufacturing infrastructure. GlobalData reports that approvals increased from 106 in 2015…