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FDA Looks to Accelerate Biosimilar Drug Development

The FDA has gone on to propose certain new policies in order to accelerate biosimilar drug development and at the same time also lower the cost pertaining to biosimilar agents when it comes to cancer as well as any...

Onshoring of Drug Product Manufacturing to Massachusetts

Moderna is set to expand its US manufacturing capabilities through the onshoring of drug product manufacturing to its present Moderna Technology Center - MTC located Norwood, Massachusetts, in a move that involves an investment of over $140m. By way of this onshoring,...

Cyclical Saviors: Cyclodextrins and Patient-Centric Drug Design

Explore how cyclodextrins in advanced biopharma delivery enhance drug stability, bioavailability, patient access and new formats for innovative treatments.

Innovations in Clinical Packaging and Labeling for Global Studies

The sophistication of clinical trial management continues to advance at an unprecedented pace, and nowhere is this transformation more evident than in clinical packaging and labeling solutions. As trials become increasingly global, complex, and patient-centric, packaging has evolved from...

Decentralized Clinical Trials: New Demands on Clinical Supply Strategies

The clinical research landscape is experiencing a significant paradigm shift toward decentralized and hybrid trial models that fundamentally alter how clinical supplies are managed, distributed, and tracked. Decentralized clinical trials (DCTs), which enable patients to participate from their homes...

The Rise of Pharma 4.0: Digital Twins, AI and Predictive Manufacturing

The pharmaceutical manufacturing industry stands at a transformative inflection point. For decades, manufacturing processes operated based on established protocols perfected through empirical experience and regulatory validation. While effective, these traditional approaches rely heavily on retrospective quality assurance, periodic environmental...

Advanced Sterile Manufacturing: Innovations Driving Aseptic Precision

Sterile pharmaceutical manufacturing represents one of the most technically demanding and highly regulated aspects of pharmaceutical production. The stakes are exceptionally high—any compromise in sterility assurance can render entire batches unusable or, worse, lead to contaminated products reaching patients...

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