BioPharma
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...
BioPharma
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,...
BioPharma
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.
BioPharma
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...
BioPharma
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...
BioPharma
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...
BioPharma
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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